Meibomian Gland DysfunctionNCT05577910
Vectored Thermal Pulsation, Intense Pulsed Light, and Eyelid Warm Compress Therapies for MGD
A study testing Vectored thermal pulsation (VTP) therapy, Intense pulsed light with meibomian gland expression (IPL+MGX) therapy and Eyelid Warm Compress Therapy (EW) in people with Meibomian Gland Dysfunction, run by Chinese University of Hong Kong at 4 sites in Hong Kong.
Trial summary
Meibomian gland dysfunction (MGD), closely associated with Dry Eye Disease (DED), is a chronic condition where terminal ducts are obstructed and/or glandular secretion changes. The efficacy of traditional treatment options, e.g. eyelid warm compress therapy (EW) is limited with low compliance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- Vectored thermal pulsation (VTP) therapy, Intense pulsed light with meibomian gland expression (IPL+MGX) therapy and Eyelid Warm Compress Therapy (EW)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 4 sitesHong Kong
- Study dates
- 8 Oct 2022to 26 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age with no upper age limit;
- Agree to attend follow-up visits and comply to treatment regimen;
- Symptomatic dry eye TFBUT (average of 3 times) ≤ 5 seconds and OSDI ≥ 13;
- Mild to moderate (level 3-4) MGD on at least one eye;
- Fitzpatrick skin type 1-4.
Who cannot join
- Contact lens wear 3 months before or during the study period;
- Use of topical (including anti-glaucomatous, cyclosporin, antibiotics) or systemic medication known to affect (worsen or improve) MGD 3 months before or during the study period;
- Major systemic (e.g. Sjogren's syndrome), dermatologic (e.g. Rosacea) known to affect MGD or ocular conditions (including thyroid eye disease, recurrent conjunctivitis, ocular allergies);
- Ocular procedures (excluding uncomplicated cataract operation) 3 months before and any ocular procedure during the study period;
- History of vision correction surgery or plan to undergo the procedure during the study period;
- Dermatological treatment (including chemical peeling, laser, IPL or energy device in the periocular and facial region) 6 months before or during the study period;
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- Contraindications to IPL therapy (including recent sun-burn, photosensitivity, active or pigmented skin lesions, cancer, implants, tattoos, semi-permanent makeup in the periocular area);
- Contraindications to VTP therapy (ocular surgery, ocular injury, ocular herpes of eye or eyelid, and ocular inflammation 3 months before the study; active ocular infection, etc.)
- Women who are pregnant, nursing, planning pregnancy, or of childbearing potential not using a reliable method of contraception.
Trial locations and contacts
4 sites in 1 country.
Hong Kong4 sites
Hong Kong Eye Hospital
Kowloon, Hong Kong
The Chinese University of Hong Kong Eye Centre (CUHKEC)
Kowloon, 000000
The CUHK Medical Centre (CUHKMC)
Shatin, 000 000
Prince of Wales Hospital
Shatin, 000000
About this study
Official title: Vectored Thermal Pulsation, Intense Pulsed Light, and Eyelid Warm Compress (VIEW) Therapies for Meibomian Gland Dysfunction- A Randomized, Assessor-masked, Active-controlled Clinical Trial
Meibomian gland dysfunction (MGD), closely associated with Dry Eye Disease (DED), is a chronic condition where terminal ducts are obstructed and/or glandular secretion changes. The efficacy of traditional treatment options, e.g. eyelid warm compress therapy (EW) is limited with low compliance. This study aims to (1)compare the efficacy and safety of two emerging alternatives- vectored thermal pulsation(VTP) or intense pulsed light and meibomian gland expression(IPL + MGX) with EW therapy; (2)identify factors predicting outcome.
This is a prospective, randomized, assessor-masked, active-controlled clinical study. 360 participants (360 study eyes) with mild-to-moderate MGD will be randomized by minimization into three arms equally, receiving either VTP by TearScience-LipiFlow® Thermal Pulsation System (month 0), IPL by Lumenis®️M22 with MGX (month 0, 1, 2, 3) or EW (twice daily). Lubricating eye drops (3% Hypromellose) will be provided for all subjects throughout the study period(15 months). Tear film breakup time will be assessed as primary outcome at month 6, 15. Serial measurements of MG, tear-film, DED-related parameters, intraocular pressure, compliance to EW, factors associated with outcomes and treatment-related complications will be conducted at baseline and each follow-up visit by masked observers at baseline and eight follow-up evaluation (month 0, 1, 2, 3, 4, 6, 9, 12, 15).
Read the detailed description
Dry eye disease (DED) is an emerging, under-recognized and under-treated epidemic of the 21st century. It is one of the commonest reasons seeking eye consultation worldwide. Depending on the diagnostic criteria, geographic location and population concerned, prevalence of DED ranges from 30 to over 50% in the Asia Pacific regions compared to around 5-10% in the United States. Up to 90% of DED is closely associated with meibomian gland dysfunction (MGD), a chronic and progressive condition characterized by terminal duct obstruction, qualitative and/or quantitative changes in the glandular secretions (meibum) which causes tear instability by increasing tear evaporation and subsequently increased tear osmolarity, ocular surface inflammation, epithelial damage and ocular surface disease. Studies suggest that MGD affects between 5-20 % of Caucasians and over 60% of Asians populations.
Conventional treatments for MGD including self-administered eyelid hygiene, eyelid warm compress therapy (EW), artificial tears, including lipid-containing lubricants are limited in their efficacies for moderate to advanced disease. Prescription medications (topical steroids, topical and oral antibiotics, topical immunomodulatory agents e.g. cyclosporine and oral omega-3 essential fatty acids) have demonstrated efficacies in improving symptoms and signs of MGD; however side-effects including preservative-related adverse events, development of antibiotic resistance, cost, accessibility, off-label use, and the need for ongoing treatments often limit their long-term use.
Despite the described range of available options, management for MGDs is often considered unsatisfactory and frustrating by clinicians and patients. Compliance to long-term, home-based self-administered therapies is known to be suboptimal while practitioner-administered treatment including meibomian gland expression (MGX) provides transient relief.
Intense pulsed light (IPL) therapy is widely used in cosmetic dermatology as well as therapeutically for a wide range of skin conditions with favourable efficacy and tolerability. Concurrent MGD improvements were observed serendipitously in patients undergoing IPL for rosacea. With growing interest in combining IPL+MGX as practitioner-administered physical therapy for MGD, recent review and meta-analysis showed its effectiveness and safety while calling to investigate its effect beyond 6 months after the last IPL treatment.
Vectored thermal pulsation (VTP) is approved by FDA as another practitioner-administered physical therapy for MGD. The device covers both the cutaneous and mucosal surfaces of the eyelids; the rear portion of the device provides heat to the MG, and the front portion gives mechanical stimulation to the eyelid skin. It evacuates the MG of the upper and lower eyelids simultaneously with minimal discomfort while protecting the cornea, rendering the experience for patients generally favorable. Recent meta-analysis showed that a single 12-minute VTP was more efficacious than EW in treating MGD.
Knowledge gaps:
Level I evidence comparing efficacies between two promising practitioner-administered therapies VTP and multi-session IPL+MGX with standard self-administered twice-daily EW for MGD is currently lacking. The onset and offset of therapeutic effects, time course of multi-session IPL+MGX, single-session VTP or twice-daily EW on MGD up to 15-month post-treatment initiation or 12-month post last session of IPL have not been studied either in an RCT setting. These important gaps will be addressed in this application.
Primary Objective:
To compare the efficacy and safety of 1-session vectored thermal pulsation (VTP) or 4-session intense pulsed light and meibomian gland expression (IPL+MGX) with twice-daily eyelid warm compress (EW) therapy for meibomian gland dysfunction (MGD).
Secondary Objectives:
- To compare the course of MGD among groups over 15 months (12-month after final IPL+MGX);
- To identify factors predicting responses and compliance to therapies.
Hypotheses:
- Both 1-session VTP and 4-session IPL+MGX are more efficacious than twice-daily EW in improving MGD;
- MGD improves earlier after VTP;
- MGD improvement lasts longer after 4-session IPL+MGX.
Study design:
This is a prospective, randomized, assessor-masked, 3-arm (1:1:1), active-controlled trial of 360 subjects with meibomian gland dysfunction contributing one study eye. For subjects with both eyes eligible, the eye with the fewest quality of expressed meibum, thinnest lipid layer, or the lowest TFBUT values (in this order) will be selected as the study eye.
A total of 360 patients with symptomatic MGD will be recruited from the participating hospitals coordinated by the Chinese University of Hong Kong (CUHK) Research Clinic, the CUHK Eye Centre (CUHKEC), Department of Ophthalmology and Visual Science, Faculty of Medicine, The CUHK.
Randomization will be carried out by a computer-generated minimization program. Minimization is a dynamic process to reduce the imbalance between trial arms with respect to a range of predefined prognostic variables, and a randomization schedule is therefore not drawn up in advance. A form describing the baseline characteristics of each subject according to these minimization criteria: gender, age, and quality of expressed meibum from the study eye. Treatment allocation will be sent to the unmasked trial coordinator for arrangement at baseline (month 0).
Enrolled patients will be randomized into one of the following groups, 1 month after recruitment during the 15-month study period receiving bilateral treatment of:
Group A: 1-session VTP at month 0; Group B: 4-session IPL+MGX at month 0,1,2,3; Group C: twice daily EW for 15 months.
All patients will be given one single topical lubricant (Hypromellose, 3mg/ml) to be used as frequently as needed from recruitment to study exit (total 16 months).
IPL or VTP is given by unmasked treating investigators not involved in data collection. Follow-up investigators collecting the data are masked to participants' treatment assignment. This information can be disclosed upon request after the completion of the study. Unmasked trial coordinators will ensure masking by reminding and accompanying each patient before and during visit. Treatment-related complications will be evaluated by all participants in a standard datasheet regardless of group assignment. Follow-up investigators will be asked if they know each participant's group assignment at each visit and why.
Tear film breakup time will be assessed as the primary outcome (month 6 and 15). Serial measurements of MG, tear-film, DED-related parameters, intraocular pressure, compliance to EW, factors associated with outcomes, and treatment-related complications will be conducted by masked investigators at baseline and eight follow-up evaluations (month 0, 1, 2, 3, 4, 6, 9, 12, 15).
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- Vectored thermal pulsation (VTP) therapy, Intense pulsed light with meibomian gland expression (IPL+MGX) therapy, Eyelid Warm Compress Therapy (EW), Topical eye drops (Hypromellose, 3mg/ml)
- Keywords
- Meibomian Gland Dysfunction, Dry Eye Disease, Vectored Thermal Pulsation therapy, Intense Pulsed Light therapy
- Medical subject headings
- Meibomian Gland Dysfunction, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vectored thermal pulsation (VTP) therapyDevice
VTP purchased from TearScience®️ is an automated thermal pulsation system that is designed to heat and simultaneously evacuate the meibomian gland contents. It is performed by the unmasked treating investigators as described by the equipment manufacturer. In brief, one to two drops of topical anesthesia are applied prior to the bilateral application of the activators. The inner portion of the activator applies a constant temperature of 42.5°C to the tarsal conjunctiva of upper and lower eyelids. Simultaneously, the outer portion of the activator applies directional, pulsatile pressure to the external eyelid surfaces (maximum 6 psi) for the 12-minute treatment cycle. Participants will receive one session of VTP treatment only (month 0).
Intense pulsed light with meibomian gland expression (IPL+MGX) therapyDevice
IPL is delivered using the proprietary "dry eye mode" setting of the Lumenis®️ M22TM system per the Toyos protocol. Pulse intensity (11-14 J/cm2) is inversely related to the Fitzpatrick skin phototype of each participant and will be used for the same patient throughout the study. IPL will be delivered to four overlapping zones inferior to each eye and a fifth pulse applied temporally adjacent to the lateral canthus four times. Both eyelids are closed and sealed with IPL-Aid disposable eye shields. MGX is immediately performed on both upper and lower eyelids of each eye and pain will be minimized by topical anesthetic. Participants will receive four-session IPL and MGX treatment (month 0, 1, 2 ,3).
Eyelid Warm Compress Therapy (EW)Behavioural
EW using warm wet towel to each eye is performed twice daily for 10 mins. A treatment diary will be given for patients randomized to EW for daily recording which will be reviewed and recorded by the unmasked study coordinator at each study visit.
Topical eye drops (Hypromellose, 3mg/ml)Drug
All patients will be given one single topical lubricant (Hypromellose, 3mg/ml) to be used as frequently as needed from recruitment to study exit (total 16 months).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | One session VTP at month 0. Receives: Device: Vectored thermal pulsation (VTP) therapy; Drug: Topical eye drops (Hypromellose, 3mg/ml) |
| Group B | Experimental | Four sessions IPL+MGX at month 0,1,2,3. Receives: Device: Intense pulsed light with meibomian gland expression (IPL+MGX) therapy; Drug: Topical eye drops (Hypromellose, 3mg/ml) |
| Group C | Active comparator | Twice daily EW for 15 months. Receives: Behavioral: Eyelid Warm Compress Therapy (EW); Drug: Topical eye drops (Hypromellose, 3mg/ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Tear film breakup time (TFBUT) at 6 months
Sodium fluorescein will be instilled in both eyes of the subject. A follow-up investigator will do the examination by slit lamp. Tear film breakup time (TFBUT) is the time to initial breakup of the tear film after a blink is measured three times and taken average.
Measured: 6 months
Change from baseline Tear film breakup time (TFBUT) at 15 months
Sodium fluorescein will be instilled in both eyes of the subject. A follow-up investigator will do the examination by slit lamp. Tear film breakup time (TFBUT) is the time to initial breakup of the tear film after a blink is measured three times and taken average.
Measured: 15 months
Secondary outcomes (21)
Change in Ocular Surface Disease Index (OSDI)
The 12-item symptom frequency-based questionnaire Ocular Surface Disease Index (OSDI) is self-administered by patients at each study visit for assessment of dry eye disease (DED) related symptoms and its severity. Final OSDI score is calculated by dividing the product of the total sum of score and 25 by the total number of answered questions, with a range from 0 to 100 (normal: 0-12, mild dry eye disease: 13-22, moderate dry eye disease: 23-32, severe dry eye disease: >33).
Measured: 15 months
Change in Standard Patient Evaluation of Eye Dryness (SPEED)
The Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire is self-administered by patients at each study visit for monitoring dry eye symptoms progression throughout the study. Final SPEED score is calculated by summating the score of all answered questions, with a range from 0 to 28 (mild dry eye symptoms: 0-4, moderate dry eye symptoms: 5-7, severe dry eye symptoms: >8).
Measured: 15 months
Change in symptom Assessment iN Dry Eye (SANDE)
The 2-item frequency- and severity-based visual analog scale Symptom Assessment iN Dry Eye (SANDE) questionnaire is self-administered by patients at each study visit to evaluate the frequency and severity of dry eye symptoms. Final SANDE score is calculated by obtaining the square root of the product of the frequency of symptoms score and the severity of symptoms score, with a range from 0 (minimal degree of dry eye symptoms) to 100 (maximal degree of dry eye symptoms)
Measured: 15 months
Change in ocular comfort index (OCI)
The Ocular Comfort Index (OCI) questionnaire is self-administered by patients at each study visit to evaluate the topical treatment outcome of dry eye symptoms. The final OCI score will be linearly rescaled which ranges from 0 (minimal degree of dry eye symptoms) to 100 (maximal degree of dry eye symptoms).
Measured: 15 months
Change in dry eye questionnaire (DEQ-5)
The Dry Eye Questionnaire (DEQ-5) is self-administered by patients at each study visit for assessment of the frequency and intensity of dry eye symptoms. The final DEQ-5 score is calculated by summating the score of all answered questions, with a range from 0 to 22. A score greater or equal to 6 is considered positive for dry eye symptoms.
Measured: 15 months
Change in tear film breakup time (TFBUT)
Sodium fluorescein will be instilled in both eyes of the subject. A follow-up investigator will do the examination by slit lamp. Tear film breakup time (TFBUT) is the time to initial breakup of the tear film after a blink is measured three times and taken average.
Measured: 15 months
Change in non-invasive keratograph break-up time (NIKBUT)
Non-invasive keratograph break-up time (NIKBUT) is measured using automated detection of the first break-up by Keratograph 5M (OCULUS, Wetzlar, Germany), while the subject maintains fixation and is requested to refrain from blinking. Three break-up time readings are averaged in each case for both eyes.
Measured: 15 months
Change in bulbar conjunctival hyperaemia
Bulbar conjunctival hyperaemia is evaluated by Keratograph 5M (OCULUS, Wetzlar, Germany) according to the proprietary JENVIS grading scale from 0 to 4.
Measured: 15 months
Change in lower tear meniscus height (TMH)
The lower tear meniscus height (TMH) is assessed using high magnification pre-calibrated digital imaging by Keratograph 5M (OCULUS, Wetzlar, Germany), and three measurement points (nasal and temporal limbus, pupil center) of the lower meniscus are averaged.
Measured: 15 months
Change in lipid layer thickness (LLT)
Lipid layer thickness (LLT) of the tear film as determined with LipiView II (TearScience, Morrisville, NC). Minimum, Maximum and Average thickness in nm will be measured.
Measured: 15 months
Change in tear interferometric fringe pattern
Tear interferometric fringe pattern is graded according to the modified Guillon-Keeler system with LipiView II (TearScience, Morrisville, NC). It will be graded according to the modified Guillon-Keeler system: grade 1, open meshwork; grade 2, closed meshwork; grade 3, wave or flow; grade 4, amorphous; grade 5, colored fringes; grade 0, non-continuous layer (non-visible or abnormal colored fringes).
Measured: 15 months
Change in meiboscore
The meiboscore grading scale uses a 0 to 3 grading scale by LipiView II (TearScience, Morrisville, NC) infrared meibography on both superior and inferior eyelids, with a grade of 0 representing no meibomian gland atrophy, with grades of 1, 2, and 3 representing 1% to 33%, 34% to 66%, and ≥67% of glands lost, respectively.
Measured: 15 months
Change in meibograde
Meibograde is evaluating gland distortion, gland shortening, and gland dropout by LipiView II (TearScience, Morrisville, NC) infrared meibography on both superior and inferior eyelids. Each of these characteristics is graded from 0-3, like the meiboscore, and then they are summed to give a total score of 0-9 per eyelid.
Measured: 15 months
Change in partial blinking rate
Partial blinking rate is reported as the percentage of incomplete blinks, which recorded by LipiView II (TearScience, Morrisville, NC).
Measured: 15 months
Change in schirmer's test (ST)
Schirmer's test (ST) will be performed by standard filter paper strips without anesthesia for 5 mins in both eyes at the same time. The wetting length by tears in each strip is recorded. The strips will be collected in sterile centrifuge tubes respectively for laboratory tests.
Measured: 15 months
Change in Lid margin and eyelash abnormalities
Lid margin and eyelash abnormalities will be accessed by a slit lamp, including lid margin thickening, rounding, notching, foaming, telangiectasia, meibomian gland capping, staphylococcal lash crusting, seborrheic lash crusting, Demodex lash cylindrical collarettes, madarosis, poliosis, and trichiasis.
All items will be graded based on a four-point scale: grade 0, absent; grade 1, mild; grade 2, moderate; grade 3, severe.
Measured: 15 months
Change in corneal and conjunctival staining score
Corneal and conjunctival damage is evaluated by corneal and conjunctival staining scores according to the Oxford grading system (six-point scale). Fluorescein sodium will be Instilled in both eyes. The staining of the eyes will be examined by follow-up investigators with a slit lamp under cobalt blue light.
Scores range from 0-5 ( absent to severe).
Measured: 15 months
Change in lid wiper epitheliopathy (LWE)
Lid wiper epitheliopathy (LWE) is evaluated relative to Korb's grading. Only the superior eyelid will be examined on the linear area of staining and severity of staining.
The linear area of staining is graded on a three-point scale (grade 0, <2 mm; grade 1, 2-4 mm; grade 2, 5-9 mm; grade 3, ≥10 mm).
The severity of staining is graded on a four-point scale (grade 0, none; grade 1, slight; grade 2, mild; grade 3, moderate; grade 4, severe).
The total grade was the sum of the grading score of the linear area of staining and severity of staining.
Measured: 15 months
Change in expressibility of meibomian glands in the meibomian glands yielding liquid secretion (MGYLS) (the inferior eyelid)
Expressibility of the inferior eyelid meibomian glands is assessed with the Meibomian Gland Evaluator (TearScience, North Carolina, USA) applied just inferior to the nasal, central, and temporal aspects of the inferior eyelid margin.
The meibomian glands yielding liquid secretion (MGYLS) is the total number of glands which yielding lipid secretions at the nasal, central, and temporal aspects of the eyelid margin (5 glands each part).
Measured: 15 months
Change in expressibility of meibomian glands in proportion of meibomian orifices yielding lipid secretions (the inferior eyelid))
Expressibility of the inferior eyelid meibomian glands is assessed with the Meibomian Gland Evaluator (TearScience, North Carolina, USA) applied just inferior to the nasal, central, and temporal aspects of the inferior eyelid margin.
The proportion of meibomian orifices yielding lipid secretions is graded on a five-point scale: 0, more than 75% (4-5 glands); 1, 50% to 75% (3 glands); 2, 25% to 50% (2 glands); 3, less than 25% (1 gland); 4, none (0 gland).
Measured: 15 months
Change in quality of expressed meibum
Each gland in each area is assessed for expressibility and graded according to a 4-point scale (grade 0, no secretion; grade 1, inspissated/ toothpaste-like expression; grade 2, cloudy fluid secretion; and grade 3, clear fluid/normal secretion). The sum scores of 15 glands will be between 0 and 45.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start8 Oct 2022
- Primary completion1 Dec 2024
- Study completion26 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, assessor-masked, 3-arm (1:1:1), active-controlled trial of 360 subjects with meibomian gland dysfunction contributing one study eye. For subjects with both eyes eligible, the eye with the most meibomian gland dropout (meiboscore), fewest expressible meibomian glands, thinnest lipid layer, or lowest TFBUT values (in this order) will be selected as the study eye. Enrolled patients will be randomized into one of the following groups, 1 month after recruitment during the 15-month study period receiving bilateral treatment of: Group A: 1-session VTP at month 0 Group B: 4-session IPL+MGX at month 0,1,2,3 Group C: twice daily EW for 15 months Topical lubricating eye drops (Hypromellose, 3mg/ml) will be the monotherapy for all subjects.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelvin Kam Lung Chong, MD, Chinese University of Hong Kong
- Investigators
- Kelvin KL Chong, MBChB, Principal investigator, The Department of Ophthalmology & Visual Sciences, the Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577910
- Sponsor's protocol ID
- HMRF-08190266
- Status last verified
- Mar 2026
- First submitted
- 27 Sep 2022
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Nelson JD, Craig JP, Akpek EK, Azar DT, Belmonte C, Bron AJ, Clayton JA, Dogru M, Dua HS, Foulks GN, Gomes JAP, Hammitt KM, Holopainen J, Jones L, Joo CK, Liu Z, Nichols JJ, Nichols KK, Novack GD, Sangwan V, Stapleton F, Tomlinson A, Tsubota K, Willcox MDP, Wolffsohn JS, Sullivan DA. TFOS DEWS II Introduction. Ocul Surf. 2017 Jul;15(3):269-275. doi: 10.1016/j.jtos.2017.05.005. Epub 2017 Jul 20. No abstract available.
PubMed 28736334Schein OD, Munoz B, Tielsch JM, Bandeen-Roche K, West S. Prevalence of dry eye among the elderly. Am J Ophthalmol. 1997 Dec;124(6):723-8. doi: 10.1016/s0002-9394(14)71688-5.
PubMed 9402817Chan TCY, Chow SSW, Wan KHN, Yuen HKL. Update on the association between dry eye disease and meibomian gland dysfunction. Hong Kong Med J. 2019 Feb;25(1):38-47. doi: 10.12809/hkmj187331. Epub 2019 Jan 31.
PubMed 30713149Schaumberg DA, Nichols JJ, Papas EB, Tong L, Uchino M, Nichols KK. The international workshop on meibomian gland dysfunction: report of the subcommittee on the epidemiology of, and associated risk factors for, MGD. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1994-2005. doi: 10.1167/iovs.10-6997e. Print 2011 Mar. No abstract available.
PubMed 21450917Nelson JD, Shimazaki J, Benitez-del-Castillo JM, Craig JP, McCulley JP, Den S, Foulks GN. The international workshop on meibomian gland dysfunction: report of the definition and classification subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1930-7. doi: 10.1167/iovs.10-6997b. Print 2011 Mar. No abstract available.
PubMed 21450914Thode AR, Latkany RA. Current and Emerging Therapeutic Strategies for the Treatment of Meibomian Gland Dysfunction (MGD). Drugs. 2015 Jul;75(11):1177-85. doi: 10.1007/s40265-015-0432-8.
PubMed 26130187Wladis EJ, Bradley EA, Bilyk JR, Yen MT, Mawn LA. Oral Antibiotics for Meibomian Gland-Related Ocular Surface Disease: A Report by the American Academy of Ophthalmology. Ophthalmology. 2016 Mar;123(3):492-6. doi: 10.1016/j.ophtha.2015.10.062. Epub 2015 Dec 23.
PubMed 26707417Dry Eye Assessment and Management Study Research Group; Asbell PA, Maguire MG, Pistilli M, Ying GS, Szczotka-Flynn LB, Hardten DR, Lin MC, Shtein RM. n-3 Fatty Acid Supplementation for the Treatment of Dry Eye Disease. N Engl J Med. 2018 May 3;378(18):1681-1690. doi: 10.1056/NEJMoa1709691. Epub 2018 Apr 13.
PubMed 29652551Lam PY, Shih KC, Fong PY, Chan TCY, Ng AL, Jhanji V, Tong L. A Review on Evidence-Based Treatments for Meibomian Gland Dysfunction. Eye Contact Lens. 2020 Jan;46(1):3-16. doi: 10.1097/ICL.0000000000000680.
PubMed 31834043Foulks GN, Nichols KK, Bron AJ, Holland EJ, McDonald MB, Nelson JD. Improving awareness, identification, and management of meibomian gland dysfunction. Ophthalmology. 2012 Oct;119(10 Suppl):S1-12. doi: 10.1016/j.ophtha.2012.06.064.
PubMed 23034341Sabeti S, Kheirkhah A, Yin J, Dana R. Management of meibomian gland dysfunction: a review. Surv Ophthalmol. 2020 Mar-Apr;65(2):205-217. doi: 10.1016/j.survophthal.2019.08.007. Epub 2019 Sep 5.
PubMed 31494111Aketa N, Shinzawa M, Kawashima M, Dogru M, Okamoto S, Tsubota K, Shimazaki J. Efficacy of Plate Expression of Meibum on Tear Function and Ocular Surface Findings in Meibomian Gland Disease. Eye Contact Lens. 2019 Jan;45(1):19-22. doi: 10.1097/ICL.0000000000000535.
PubMed 30252688Toyos R, McGill W, Briscoe D. Intense pulsed light treatment for dry eye disease due to meibomian gland dysfunction; a 3-year retrospective study. Photomed Laser Surg. 2015 Jan;33(1):41-6. doi: 10.1089/pho.2014.3819.
PubMed 25594770Wladis EJ, Aakalu VK, Foster JA, Freitag SK, Sobel RK, Tao JP, Yen MT. Intense Pulsed Light for Meibomian Gland Disease: A Report by the American Academy of Ophthalmology. Ophthalmology. 2020 Sep;127(9):1227-1233. doi: 10.1016/j.ophtha.2020.03.009. Epub 2020 Apr 21.
PubMed 32327256Tashbayev B, Yazdani M, Arita R, Fineide F, Utheim TP. Intense pulsed light treatment in meibomian gland dysfunction: A concise review. Ocul Surf. 2020 Oct;18(4):583-594. doi: 10.1016/j.jtos.2020.06.002. Epub 2020 Jul 3.
PubMed 32629039
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vectored Thermal Pulsation, Intense Pulsed Light, and Eyelid Warm Compress (VIEW) Therapies for Meibomian Gland Dysfunction- A Randomized, Assessor-masked, Active-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05577910
- Acronym / sponsor ID
- HMRF-08190266
- Conditions
- Meibomian Gland Dysfunction
- Keywords
- Meibomian Gland Dysfunction, Dry Eye Disease, Vectored Thermal Pulsation therapy, Intense Pulsed Light therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 8 Oct 2022 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 26 Jan 2025 (actual)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Meibomian gland dysfunction (MGD), closely associated with Dry Eye Disease (DED), is a chronic condition where terminal ducts are obstructed and/or glandular secretion changes. The efficacy of traditional treatment options, e.g. eyelid warm compress therapy (EW) is limited with low compliance. This study aims to (1)compare the efficacy and safety of two emerging alternatives- vectored thermal pulsation(VTP) or intense pulsed light and meibomian gland expression(IPL + MGX) with EW therapy; (2)identify factors predicting outcome.
This is a prospective, randomized, assessor-masked, active-controlled clinical study. 360 participants (360 study eyes) with mild-to-moderate MGD will be randomized by minimization into three arms equally, receiving either VTP by TearScience-LipiFlow® Thermal Pulsation System (month 0), IPL by Lumenis®️M22 with MGX (month 0, 1, 2, 3) or EW (twice daily). Lubricating eye drops (3% Hypromellose) will be provided for all subjects throughout the study period(15 months). Tear film breakup time will be assessed as primary outcome at month 6, 15. Serial measurements of MG, tear-film, DED-related parameters, intraocular pressure, compliance to EW, factors associated with outcomes and treatment-related complications will be conducted at baseline and each follow-up visit by masked observers at baseline and eight follow-up evaluation (month 0, 1, 2, 3, 4, 6, 9, 12, 15).
Detailed description
Dry eye disease (DED) is an emerging, under-recognized and under-treated epidemic of the 21st century. It is one of the commonest reasons seeking eye consultation worldwide. Depending on the diagnostic criteria, geographic location and population concerned, prevalence of DED ranges from 30 to over 50% in the Asia Pacific regions compared to around 5-10% in the United States. Up to 90% of DED is closely associated with meibomian gland dysfunction (MGD), a chronic and progressive condition characterized by terminal duct obstruction, qualitative and/or quantitative changes in the glandular secretions (meibum) which causes tear instability by increasing tear evaporation and subsequently increased tear osmolarity, ocular surface inflammation, epithelial damage and ocular surface disease. Studies suggest that MGD affects between 5-20 % of Caucasians and over 60% of Asians populations.
Conventional treatments for MGD including self-administered eyelid hygiene, eyelid warm compress therapy (EW), artificial tears, including lipid-containing lubricants are limited in their efficacies for moderate to advanced disease. Prescription medications (topical steroids, topical and oral antibiotics, topical immunomodulatory agents e.g. cyclosporine and oral omega-3 essential fatty acids) have demonstrated efficacies in improving symptoms and signs of MGD; however side-effects including preservative-related adverse events, development of antibiotic resistance, cost, accessibility, off-label use, and the need for ongoing treatments often limit their long-term use.
Despite the described range of available options, management for MGDs is often considered unsatisfactory and frustrating by clinicians and patients. Compliance to long-term, home-based self-administered therapies is known to be suboptimal while practitioner-administered treatment including meibomian gland expression (MGX) provides transient relief.
Intense pulsed light (IPL) therapy is widely used in cosmetic dermatology as well as therapeutically for a wide range of skin conditions with favourable efficacy and tolerability. Concurrent MGD improvements were observed serendipitously in patients undergoing IPL for rosacea. With growing interest in combining IPL+MGX as practitioner-administered physical therapy for MGD, recent review and meta-analysis showed its effectiveness and safety while calling to investigate its effect beyond 6 months after the last IPL treatment.
Vectored thermal pulsation (VTP) is approved by FDA as another practitioner-administered physical therapy for MGD. The device covers both the cutaneous and mucosal surfaces of the eyelids; the rear portion of the device provides heat to the MG, and the front portion gives mechanical stimulation to the eyelid skin. It evacuates the MG of the upper and lower eyelids simultaneously with minimal discomfort while protecting the cornea, rendering the experience for patients generally favorable. Recent meta-analysis showed that a single 12-minute VTP was more efficacious than EW in treating MGD.
Knowledge gaps:
Level I evidence comparing efficacies between two promising practitioner-administered therapies VTP and multi-session IPL+MGX with standard self-administered twice-daily EW for MGD is currently lacking. The onset and offset of therapeutic effects, time course of multi-session IPL+MGX, single-session VTP or twice-daily EW on MGD up to 15-month post-treatment initiation or 12-month post last session of IPL have not been studied either in an RCT setting. These important gaps will be addressed in this application.
Primary Objective:
To compare the efficacy and safety of 1-session vectored thermal pulsation (VTP) or 4-session intense pulsed light and meibomian gland expression (IPL+MGX) with twice-daily eyelid warm compress (EW) therapy for meibomian gland dysfunction (MGD).
Secondary Objectives:
- To compare the course of MGD among groups over 15 months (12-month after final IPL+MGX);
- To identify factors predicting responses and compliance to therapies.
Hypotheses:
- Both 1-session VTP and 4-session IPL+MGX are more efficacious than twice-daily EW in improving MGD;
- MGD improves earlier after VTP;
- MGD improvement lasts longer after 4-session IPL+MGX.
Study design:
This is a prospective, randomized, assessor-masked, 3-arm (1:1:1), active-controlled trial of 360 subjects with meibomian gland dysfunction contributing one study eye. For subjects with both eyes eligible, the eye with the fewest quality of expressed meibum, thinnest lipid layer, or the lowest TFBUT values (in this order) will be selected as the study eye.
A total of 360 patients with symptomatic MGD will be recruited from the participating hospitals coordinated by the Chinese University of Hong Kong (CUHK) Research Clinic, the CUHK Eye Centre (CUHKEC), Department of Ophthalmology and Visual Science, Faculty of Medicine, The CUHK.
Randomization will be carried out by a computer-generated minimization program. Minimization is a dynamic process to reduce the imbalance between trial arms with respect to a range of predefined prognostic variables, and a randomization schedule is therefore not drawn up in advance. A form describing the baseline characteristics of each subject according to these minimization criteria: gender, age, and quality of expressed meibum from the study eye. Treatment allocation will be sent to the unmasked trial coordinator for arrangement at baseline (month 0).
Enrolled patients will be randomized into one of the following groups, 1 month after recruitment during the 15-month study period receiving bilateral treatment of:
Group A: 1-session VTP at month 0; Group B: 4-session IPL+MGX at month 0,1,2,3; Group C: twice daily EW for 15 months.
All patients will be given one single topical lubricant (Hypromellose, 3mg/ml) to be used as frequently as needed from recruitment to study exit (total 16 months).
IPL or VTP is given by unmasked treating investigators not involved in data collection. Follow-up investigators collecting the data are masked to participants' treatment assignment. This information can be disclosed upon request after the completion of the study. Unmasked trial coordinators will ensure masking by reminding and accompanying each patient before and during visit. Treatment-related complications will be evaluated by all participants in a standard datasheet regardless of group assignment. Follow-up investigators will be asked if they know each participant's group assignment at each visit and why.
Tear film breakup time will be assessed as the primary outcome (month 6 and 15). Serial measurements of MG, tear-film, DED-related parameters, intraocular pressure, compliance to EW, factors associated with outcomes, and treatment-related complications will be conducted by masked investigators at baseline and eight follow-up evaluations (month 0, 1, 2, 3, 4, 6, 9, 12, 15).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a prospective, randomized, assessor-masked, 3-arm (1:1:1), active-controlled trial of 360 subjects with meibomian gland dysfunction contributing one study eye. For subjects with both eyes eligible, the eye with the most meibomian gland dropout (meiboscore), fewest expressible meibomian glands, thinnest lipid layer, or lowest TFBUT values (in this order) will be selected as the study eye. Enrolled patients will be randomized into one of the following groups, 1 month after recruitment during the 15-month study period receiving bilateral treatment of: Group A: 1-session VTP at month 0 Group B: 4-session IPL+MGX at month 0,1,2,3 Group C: twice daily EW for 15 months Topical lubricating eye drops (Hypromellose, 3mg/ml) will be the monotherapy for all subjects.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Vectored thermal pulsation (VTP) therapy, Drug: Topical eye drops (Hypromellose, 3mg/ml)One session VTP at month 0. |
| Group B | Experimental | Device: Intense pulsed light with meibomian gland expression (IPL+MGX) therapy, Drug: Topical eye drops (Hypromellose, 3mg/ml)Four sessions IPL+MGX at month 0,1,2,3. |
| Group C | Active comparator | Behavioral: Eyelid Warm Compress Therapy (EW), Drug: Topical eye drops (Hypromellose, 3mg/ml)Twice daily EW for 15 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years of age with no upper age limit;
- Agree to attend follow-up visits and comply to treatment regimen;
- Symptomatic dry eye TFBUT (average of 3 times) ≤ 5 seconds and OSDI ≥ 13;
- Mild to moderate (level 3-4) MGD on at least one eye;
- Fitzpatrick skin type 1-4.
Key exclusion criteria (9 listed)
- Contact lens wear 3 months before or during the study period;
- Use of topical (including anti-glaucomatous, cyclosporin, antibiotics) or systemic medication known to affect (worsen or improve) MGD 3 months before or during the study period;
- Major systemic (e.g. Sjogren's syndrome), dermatologic (e.g. Rosacea) known to affect MGD or ocular conditions (including thyroid eye disease, recurrent conjunctivitis, ocular allergies);
- Ocular procedures (excluding uncomplicated cataract operation) 3 months before and any ocular procedure during the study period;
- History of vision correction surgery or plan to undergo the procedure during the study period;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vectored thermal pulsation (VTP) therapyVTP purchased from TearScience®️ is an automated thermal pulsation system that is designed to heat and simultaneously evacuate the meibomian gland contents. It is performed by the unmasked treating investigators as described by the equipment manufacturer. In brief, one to two drops of topical anesthesia are applied prior to the bilateral application of the activators. The inner portion of the activator applies a constant temperature of 42.5°C to the tarsal conjunctiva of upper and lower eyelids. Simultaneously, the outer portion of the activator applies directional, pulsatile pressure to the external eyelid surfaces (maximum 6 psi) for the 12-minute treatment cycle. Participants will receive one session of VTP treatment only (month 0). | Device | Group A |
| Intense pulsed light with meibomian gland expression (IPL+MGX) therapyIPL is delivered using the proprietary "dry eye mode" setting of the Lumenis®️ M22TM system per the Toyos protocol. Pulse intensity (11-14 J/cm2) is inversely related to the Fitzpatrick skin phototype of each participant and will be used for the same patient throughout the study. IPL will be delivered to four overlapping zones inferior to each eye and a fifth pulse applied temporally adjacent to the lateral canthus four times. Both eyelids are closed and sealed with IPL-Aid disposable eye shields. MGX is immediately performed on both upper and lower eyelids of each eye and pain will be minimized by topical anesthetic. Participants will receive four-session IPL and MGX treatment (month 0, 1, 2 ,3). | Device | Group B |
| Eyelid Warm Compress Therapy (EW)EW using warm wet towel to each eye is performed twice daily for 10 mins. A treatment diary will be given for patients randomized to EW for daily recording which will be reviewed and recorded by the unmasked study coordinator at each study visit. | Behavioural | Group C |
| Topical eye drops (Hypromellose, 3mg/ml)All patients will be given one single topical lubricant (Hypromellose, 3mg/ml) to be used as frequently as needed from recruitment to study exit (total 16 months). | Drug | Group A, Group B, Group C |
Primary outcome
Change from baseline Tear film breakup time (TFBUT) at 6 months
Time frame: 6 months
Sodium fluorescein will be instilled in both eyes of the subject. A follow-up investigator will do the examination by slit lamp. Tear film breakup time (TFBUT) is the time to initial breakup of the tear film after a blink is measured three times and taken average.
Change from baseline Tear film breakup time (TFBUT) at 15 months
Time frame: 15 months
Sodium fluorescein will be instilled in both eyes of the subject. A follow-up investigator will do the examination by slit lamp. Tear film breakup time (TFBUT) is the time to initial breakup of the tear film after a blink is measured three times and taken average.
21 secondary outcomes
Change in Ocular Surface Disease Index (OSDI)
Time frame: 15 months
Change in Standard Patient Evaluation of Eye Dryness (SPEED)
Time frame: 15 months
Change in symptom Assessment iN Dry Eye (SANDE)
Time frame: 15 months
Change in ocular comfort index (OCI)
Time frame: 15 months
Change in dry eye questionnaire (DEQ-5)
Time frame: 15 months
Change in tear film breakup time (TFBUT)
Time frame: 15 months
Change in non-invasive keratograph break-up time (NIKBUT)
Time frame: 15 months
Change in bulbar conjunctival hyperaemia
Time frame: 15 months
Change in lower tear meniscus height (TMH)
Time frame: 15 months
Change in lipid layer thickness (LLT)
Time frame: 15 months
Change in tear interferometric fringe pattern
Time frame: 15 months
Change in meiboscore
Time frame: 15 months
Change in meibograde
Time frame: 15 months
Change in partial blinking rate
Time frame: 15 months
Change in schirmer's test (ST)
Time frame: 15 months
Change in Lid margin and eyelash abnormalities
Time frame: 15 months
Change in corneal and conjunctival staining score
Time frame: 15 months
Change in lid wiper epitheliopathy (LWE)
Time frame: 15 months
Change in expressibility of meibomian glands in the meibomian glands yielding liquid secretion (MGYLS) (the inferior eyelid)
Time frame: 15 months
Change in expressibility of meibomian glands in proportion of meibomian orifices yielding lipid secretions (the inferior eyelid))
Time frame: 15 months
Change in quality of expressed meibum
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 28736334Nelson JD, Craig JP, Akpek EK, Azar DT, Belmonte C, Bron AJ, Clayton JA, Dogru M, Dua HS, Foulks GN, Gomes JAP, Hammitt KM, Holopainen J, Jones L, Joo CK, Liu Z, Nichols JJ, Nichols KK, Novack GD, Sangwan V, Stapleton F, Tomlinson A, Tsubota K, Willcox MDP, Wolffsohn JS, Sullivan DA. TFOS DEWS II Introduction. Ocul Surf. 2017 Jul;15(3):269-275. doi: 10.1016/j.jtos.2017.05.005. Epub 2017 Jul 20. No abstract available.
- Background: PubMed 9402817Schein OD, Munoz B, Tielsch JM, Bandeen-Roche K, West S. Prevalence of dry eye among the elderly. Am J Ophthalmol. 1997 Dec;124(6):723-8. doi: 10.1016/s0002-9394(14)71688-5.
- Background: PubMed 30713149Chan TCY, Chow SSW, Wan KHN, Yuen HKL. Update on the association between dry eye disease and meibomian gland dysfunction. Hong Kong Med J. 2019 Feb;25(1):38-47. doi: 10.12809/hkmj187331. Epub 2019 Jan 31.
- Background: PubMed 21450917Schaumberg DA, Nichols JJ, Papas EB, Tong L, Uchino M, Nichols KK. The international workshop on meibomian gland dysfunction: report of the subcommittee on the epidemiology of, and associated risk factors for, MGD. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1994-2005. doi: 10.1167/iovs.10-6997e. Print 2011 Mar. No abstract available.
- Background: PubMed 21450914Nelson JD, Shimazaki J, Benitez-del-Castillo JM, Craig JP, McCulley JP, Den S, Foulks GN. The international workshop on meibomian gland dysfunction: report of the definition and classification subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1930-7. doi: 10.1167/iovs.10-6997b. Print 2011 Mar. No abstract available.
- Background: PubMed 26130187Thode AR, Latkany RA. Current and Emerging Therapeutic Strategies for the Treatment of Meibomian Gland Dysfunction (MGD). Drugs. 2015 Jul;75(11):1177-85. doi: 10.1007/s40265-015-0432-8.
- Background: PubMed 26707417Wladis EJ, Bradley EA, Bilyk JR, Yen MT, Mawn LA. Oral Antibiotics for Meibomian Gland-Related Ocular Surface Disease: A Report by the American Academy of Ophthalmology. Ophthalmology. 2016 Mar;123(3):492-6. doi: 10.1016/j.ophtha.2015.10.062. Epub 2015 Dec 23.
- Background: PubMed 29652551Dry Eye Assessment and Management Study Research Group; Asbell PA, Maguire MG, Pistilli M, Ying GS, Szczotka-Flynn LB, Hardten DR, Lin MC, Shtein RM. n-3 Fatty Acid Supplementation for the Treatment of Dry Eye Disease. N Engl J Med. 2018 May 3;378(18):1681-1690. doi: 10.1056/NEJMoa1709691. Epub 2018 Apr 13.
- Background: PubMed 31834043Lam PY, Shih KC, Fong PY, Chan TCY, Ng AL, Jhanji V, Tong L. A Review on Evidence-Based Treatments for Meibomian Gland Dysfunction. Eye Contact Lens. 2020 Jan;46(1):3-16. doi: 10.1097/ICL.0000000000000680.
- Background: PubMed 23034341Foulks GN, Nichols KK, Bron AJ, Holland EJ, McDonald MB, Nelson JD. Improving awareness, identification, and management of meibomian gland dysfunction. Ophthalmology. 2012 Oct;119(10 Suppl):S1-12. doi: 10.1016/j.ophtha.2012.06.064.
- Background: PubMed 31494111Sabeti S, Kheirkhah A, Yin J, Dana R. Management of meibomian gland dysfunction: a review. Surv Ophthalmol. 2020 Mar-Apr;65(2):205-217. doi: 10.1016/j.survophthal.2019.08.007. Epub 2019 Sep 5.
- Background: PubMed 30252688Aketa N, Shinzawa M, Kawashima M, Dogru M, Okamoto S, Tsubota K, Shimazaki J. Efficacy of Plate Expression of Meibum on Tear Function and Ocular Surface Findings in Meibomian Gland Disease. Eye Contact Lens. 2019 Jan;45(1):19-22. doi: 10.1097/ICL.0000000000000535.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelvin KL Chong, MBChB principal investigator
The Department of Ophthalmology & Visual Sciences, the Chinese University of Hong Kong
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vectored thermal pulsation (VTP) therapy, Intense pulsed light with meibomian gland expression (IPL+MGX) therapy and Eyelid Warm Compress Therapy (EW) in people with Meibomian Gland Dysfunction, run by Chinese University of Hong Kong at 4 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Tear film breakup time (TFBUT) at 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05577910, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.