Dry Eye DiseaseNCT05857579
Diamond Bur Microblepharoexfoliation, Intense Pulse Light and Meibomian Gland Expression for Evaporative Dry Eye
A study testing Microblepharoexfoliation, Intense pulse light and Meibomian gland expression in people with Dry Eye Disease, run by University of Seville at 1 site in Spain.
Trial summary
The goal of this clinical trial is to assess the efficacy and safety of microblepharoeexfoliation (MBE), intense pulse light (IPL) and meibomian gland expression (MGX) combination in patients with meibomian gland dysfunction (MGD). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Microblepharoexfoliation, Intense pulse light and Meibomian gland expression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2022to 1 Jan 2023
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- DED diagnosis according to DEWS II meeting one of the following conditions: (2.1) ocular surface disease index (OSDI) score ≥ 13; (2.2) NIBUT < 10 seconds; and (2.3) ocular surface staining with > 5 or 9 corneal or conjunctival stains, respectively.
- MGD diagnosis according to the international workshop on MGD meeting two of the following conditions: (3.1) irregularity of the eyelid margin or mucocutaneous junction; (3.2) vascularity of the eyelid margin; (3.3) plugged or capped Meibomian gland orifices; (3.4) Meibomian gland atrophy; or (3.5) decreased meibum quality and quantity
Who cannot join
- Skin pathologies that prevent IPL treatment
- All corneal disorders that affect diagnostic tests, such as: (2.1) active corneal infections; and (2.2) corneal dystrophies.
- Active ocular allergy.
- Pregnant or lactating women..
- Patients who did not understand or comprehend the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diamond Bur Microblepharoexfoliation Combined With Intense Pulse Light and Meibomian Gland Expression for Evaporative Dry Eye: A Short-term Controlled Study
The goal of this clinical trial is to assess the efficacy and safety of microblepharoeexfoliation (MBE), intense pulse light (IPL) and meibomian gland expression (MGX) combination in patients with meibomian gland dysfunction (MGD).
The main question it aims to answer are:
- Does MBE-IPL-MGX treatment improve dry eye symptoms?
- Does MBE-IPL-MGX treatment improve dry eye signs?
Participants were assigned to receive either three sessions of MBE-IPL-MGX treatment and home-based therapy (treatment group) or home-based therapy alone (control group).
The investigators will compare both groups to see if MBE-IPL-MGX treatment is superior to home-based therapy.
Read the detailed description
MBE is a novel in-office treatment that works by exfoliating the eyelid margins to remove the accumulated biofilm debris, epithelial keratinization and capped meibomian glands, resulting in better meibum outflow . Different studies have shown that MBE improves DED symptoms [1,2], demodex blepharitis [1-4] and meibomian gland function [2,3,5] In addition, meta-analyses recommend combining IPL with meibomian gland expression (MGX) compared to IPL or MGX alone [6-8]. However, the investigators have not found any studies evaluating the benefits of MBE combined with IPL and MGX.
Consequently, the purpose of the current study is to evaluate whether MBE combined with IPL and MGX leads to an improvement of symptoms and signs in patients with DED due to MGD.
- Conditions
- Dry Eye Disease
- Being tested
- Microblepharoexfoliation, Intense pulse light, Meibomian gland expression, Home-based therapy
- Keywords
- Microblepharoexfoliation, Intense pulse light, Meibomian gland expression, Meibomian gland dysfunction
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroblepharoexfoliationProcedure or surgery
Also called MBE
MBE was performed using the yokefellow instrument (Youke Electronic Corporation, Guangzhou, China), which contains a handpiece with a 1.80 mm diameter medical-grade diamond bur. Patients underwent MBE on the upper and lower lid margin of both eyes at 500 rpm until complete removal of accumulated biofilm debris, epithelial keratinization or capped meibomian glands. MBE was carried out only in the first combined treatment session.
Intense pulse lightProcedure or surgery
Also called IPL
IPL treatment was carried out with Thermaeye Plus (MDS Medical Technologies SL, Barcelona, Spain). The procedure began by applying an ultrasound gel (Carmado SL, Alicante, Spain) to the patient's periocular areas and upper eyelids. In the periocular areas, 6 light pulses were applied; 4 light pulses on the skin below the lower eyelid (with handpiece placed horizontally in the first pass and vertically in the second pass) and 2 light pulses on the canthal area (with handpiece placed vertically in first and second pass). The parameters were as follows: (1) Filter: 650 nm; (2) fluence: 9 j/cm2; (3) pulses: 2; (4) duration: 3 ms; (5) Delay: 20 ms; and (6) Cooling: 70%. In the upper eyelids, 4 light pulses were applied; 2 light pulses in the first and second pass, respectively. The parameters were as follows: (1) Filter: 650 nm; (2) Fluence: 5 j/cm2; (3) pulses: 1; (4) duration: 3 ms and (5) Cooling: 70%.
Meibomian gland expressionProcedure or surgery
Also called MGX
Finally, the MGX was performed on both upper and lower eyelids of each eye with a Collins forceps (Medi Instrument Inc, New York, USA).
Home-based therapyDrug
Also called HBT
Home-based therapy was based on Therapearl eye mask warming compress (Bausch \& Lomb, Madrid, Spain) twice a day and Eyestil synfo eyedrops (Sifi Iberica SL, Madrid, Spain) 4 times a day during the study
| Study group | Role | What they receive |
|---|---|---|
| MBE-IPL-MGX treatment and home-based therapy. | Experimental | In this arm, participants received three sessions of MBE-IPL-MGX treatment and home-based therapy. Receives: Procedure: Microblepharoexfoliation; Procedure: Intense pulse light; Procedure: Meibomian gland expression; Drug: Home-based therapy |
| Home-based therapy | Active comparator | In this arm, participants received home-based therapy alone. Receives: Drug: Home-based therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular surface disease index (OSDI) questionnaire.
Values from 0 (Better) to 100 (Worse)
Measured: Change from Baseline OSDI at 2 months.
Tear meniscus height (TMH)
Measured: Change from Baseline TMH at 2 months.
Tear meniscus area (TMA)
Measured: Change from Baseline TMA at 2 months.
Noninvasive tear film break-up time (NIBUT).
Measured: Change from Baseline NIBUT at 2 months.
Lipid Layer Grade (LLG)
Values from 0 (Better) to 4 (Worse)
Measured: Change from Baseline LLG at 2 months.
Ciliary hyperemia
Values from 0 (Better) to 100 (Worse)
Measured: Change from Baseline Ciliary Hyperemia at 2 months.
Conjunctival hyperemia
Values from 0 (Better) to 100 (Worse)
Measured: Change from Baseline Conjunctival Hyperemia at 2 months.
Meibomian glands Loss area (LAMG)
Values from 0 (Better) to 100 (Worse)
Measured: Change from Baseline LAMG at 2 months.
Meibomian gland secretions (MGS)
Values from 0 (Worse) to 45 (Better)
Measured: Change from Baseline MGS at 2 months.
Meibomian gland Dysfunction Grade (MGD Grade)
Values from 0 (Better) to 4 (Worse)
Measured: Change from Baseline MGD grade at 2 months.
Ocular surface staining (OSS).
Values from 0 (Better) to 4 (Worse)
Measured: Change from Baseline OSS at 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 Apr 2022
- Primary completion1 Nov 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Ballesteros Sánchez, University of Seville
- Investigators
- Antonio Ballesteros Sánchez, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857579
- Sponsor's protocol ID
- CIVIUS-ABS-001
- Status last verified
- May 2023
- First submitted
- 8 Apr 2023
- Last updated
- 12 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Murphy O, O'Dwyer V, Lloyd-McKernan A. The efficacy of tea tree face wash, 1, 2-Octanediol and microblepharoexfoliation in treating Demodex folliculorum blepharitis. Cont Lens Anterior Eye. 2018 Feb;41(1):77-82. doi: 10.1016/j.clae.2017.10.012. Epub 2017 Oct 23.
PubMed 29074306Mohammad-Rabei H, Arabi A, Shahraki T, Rezaee-Alam Z, Baradaran-Rafii A. Role of Blepharoexfoliation in Demodex Blepharitis: A Randomized Comparative Study. Cornea. 2023 Jan 1;42(1):44-51. doi: 10.1097/ICO.0000000000003046. Epub 2022 Apr 13.
PubMed 35439775Epstein IJ, Rosenberg E, Stuber R, Choi MB, Donnenfeld ED, Perry HD. Double-Masked and Unmasked Prospective Study of Terpinen-4-ol Lid Scrubs With Microblepharoexfoliation for the Treatment of Demodex Blepharitis. Cornea. 2020 Apr;39(4):408-416. doi: 10.1097/ICO.0000000000002243.
PubMed 31939919Siddireddy JS, Tan J, Vijay AK, Willcox MDP. The Effect of Microblepharon Exfoliation on Clinical Correlates of Contact Lens Discomfort. Optom Vis Sci. 2019 Mar;96(3):187-199. doi: 10.1097/OPX.0000000000001354.
PubMed 30801507Sambhi RS, Sambhi GDS, Mather R, Malvankar-Mehta MS. Intense pulsed light therapy with meibomian gland expression for dry eye disease. Can J Ophthalmol. 2020 Jun;55(3):189-198. doi: 10.1016/j.jcjo.2019.11.009. Epub 2020 Jan 13.
PubMed 31941589Leng X, Shi M, Liu X, Cui J, Sun H, Lu X. Intense pulsed light for meibomian gland dysfunction: a systematic review and meta-analysis. Graefes Arch Clin Exp Ophthalmol. 2021 Jan;259(1):1-10. doi: 10.1007/s00417-020-04834-1. Epub 2020 Jul 28.
PubMed 32725403Miao S, Yan R, Jia Y, Pan Z. Effect of Intense Pulsed Light Therapy in Dry Eye Disease Caused by Meibomian Gland Dysfunction: A Systematic Review and Meta-Analysis. Eye Contact Lens. 2022 Oct 1;48(10):424-429. doi: 10.1097/ICL.0000000000000934. Epub 2022 Sep 5.
PubMed 36044829
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diamond Bur Microblepharoexfoliation Combined With Intense Pulse Light and Meibomian Gland Expression for Evaporative Dry Eye: A Short-term Controlled Study
- ClinicalTrials.gov ID
- NCT05857579
- Acronym / sponsor ID
- CIVIUS-ABS-001
- Conditions
- Dry Eye Disease
- Keywords
- Microblepharoexfoliation, Intense pulse light, Meibomian gland expression, Meibomian gland dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 12 May 2023 (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.
The goal of this clinical trial is to assess the efficacy and safety of microblepharoeexfoliation (MBE), intense pulse light (IPL) and meibomian gland expression (MGX) combination in patients with meibomian gland dysfunction (MGD).
The main question it aims to answer are:
- Does MBE-IPL-MGX treatment improve dry eye symptoms?
- Does MBE-IPL-MGX treatment improve dry eye signs?
Participants were assigned to receive either three sessions of MBE-IPL-MGX treatment and home-based therapy (treatment group) or home-based therapy alone (control group).
The investigators will compare both groups to see if MBE-IPL-MGX treatment is superior to home-based therapy.
Detailed description
MBE is a novel in-office treatment that works by exfoliating the eyelid margins to remove the accumulated biofilm debris, epithelial keratinization and capped meibomian glands, resulting in better meibum outflow . Different studies have shown that MBE improves DED symptoms [1,2], demodex blepharitis [1-4] and meibomian gland function [2,3,5] In addition, meta-analyses recommend combining IPL with meibomian gland expression (MGX) compared to IPL or MGX alone [6-8]. However, the investigators have not found any studies evaluating the benefits of MBE combined with IPL and MGX.
Consequently, the purpose of the current study is to evaluate whether MBE combined with IPL and MGX leads to an improvement of symptoms and signs in patients with DED due to MGD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBE-IPL-MGX treatment and home-based therapy. | Experimental | Procedure: Microblepharoexfoliation, Procedure: Intense pulse light, Procedure: Meibomian gland expression, Drug: Home-based therapyIn this arm, participants received three sessions of MBE-IPL-MGX treatment and home-based therapy. |
| Home-based therapy | Active comparator | Drug: Home-based therapyIn this arm, participants received home-based therapy alone. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- DED diagnosis according to DEWS II meeting one of the following conditions: (2.1) ocular surface disease index (OSDI) score ≥ 13; (2.2) NIBUT < 10 seconds; and (2.3) ocular surface staining with > 5 or 9 corneal or conjunctival stains, respectively.
- MGD diagnosis according to the international workshop on MGD meeting two of the following conditions: (3.1) irregularity of the eyelid margin or mucocutaneous junction; (3.2) vascularity of the eyelid margin; (3.3) plugged or capped Meibomian gland orifices; (3.4) Meibomian gland atrophy; or (3.5) decreased meibum quality and quantity
Key exclusion criteria (5 listed)
- Skin pathologies that prevent IPL treatment
- All corneal disorders that affect diagnostic tests, such as: (2.1) active corneal infections; and (2.2) corneal dystrophies.
- Active ocular allergy.
- Pregnant or lactating women..
- Patients who did not understand or comprehend the informed consent.
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 |
|---|---|---|
| MicroblepharoexfoliationAlso: MBEMBE was performed using the yokefellow instrument (Youke Electronic Corporation, Guangzhou, China), which contains a handpiece with a 1.80 mm diameter medical-grade diamond bur. Patients underwent MBE on the upper and lower lid margin of both eyes at 500 rpm until complete removal of accumulated biofilm debris, epithelial keratinization or capped meibomian glands. MBE was carried out only in the first combined treatment session. | Procedure or surgery | MBE-IPL-MGX treatment and home-based therapy. |
| Intense pulse lightAlso: IPLIPL treatment was carried out with Thermaeye Plus (MDS Medical Technologies SL, Barcelona, Spain). The procedure began by applying an ultrasound gel (Carmado SL, Alicante, Spain) to the patient's periocular areas and upper eyelids. In the periocular areas, 6 light pulses were applied; 4 light pulses on the skin below the lower eyelid (with handpiece placed horizontally in the first pass and vertically in the second pass) and 2 light pulses on the canthal area (with handpiece placed vertically in first and second pass). The parameters were as follows: (1) Filter: 650 nm; (2) fluence: 9 j/cm2; (3) pulses: 2; (4) duration: 3 ms; (5) Delay: 20 ms; and (6) Cooling: 70%. In the upper eyelids, 4 light pulses were applied; 2 light pulses in the first and second pass, respectively. The parameters were as follows: (1) Filter: 650 nm; (2) Fluence: 5 j/cm2; (3) pulses: 1; (4) duration: 3 ms and (5) Cooling: 70%. | Procedure or surgery | MBE-IPL-MGX treatment and home-based therapy. |
| Meibomian gland expressionAlso: MGXFinally, the MGX was performed on both upper and lower eyelids of each eye with a Collins forceps (Medi Instrument Inc, New York, USA). | Procedure or surgery | MBE-IPL-MGX treatment and home-based therapy. |
| Home-based therapyAlso: HBTHome-based therapy was based on Therapearl eye mask warming compress (Bausch \& Lomb, Madrid, Spain) twice a day and Eyestil synfo eyedrops (Sifi Iberica SL, Madrid, Spain) 4 times a day during the study | Drug | Home-based therapy, MBE-IPL-MGX treatment and home-based therapy. |
Primary outcome
Ocular surface disease index (OSDI) questionnaire.
Time frame: Change from Baseline OSDI at 2 months.
Values from 0 (Better) to 100 (Worse)
Tear meniscus height (TMH)
Time frame: Change from Baseline TMH at 2 months.
Tear meniscus area (TMA)
Time frame: Change from Baseline TMA at 2 months.
Noninvasive tear film break-up time (NIBUT).
Time frame: Change from Baseline NIBUT at 2 months.
Lipid Layer Grade (LLG)
Time frame: Change from Baseline LLG at 2 months.
Values from 0 (Better) to 4 (Worse)
Ciliary hyperemia
Time frame: Change from Baseline Ciliary Hyperemia at 2 months.
Values from 0 (Better) to 100 (Worse)
Conjunctival hyperemia
Time frame: Change from Baseline Conjunctival Hyperemia at 2 months.
Values from 0 (Better) to 100 (Worse)
Meibomian glands Loss area (LAMG)
Time frame: Change from Baseline LAMG at 2 months.
Values from 0 (Better) to 100 (Worse)
Meibomian gland secretions (MGS)
Time frame: Change from Baseline MGS at 2 months.
Values from 0 (Worse) to 45 (Better)
Meibomian gland Dysfunction Grade (MGD Grade)
Time frame: Change from Baseline MGD grade at 2 months.
Values from 0 (Better) to 4 (Worse)
Ocular surface staining (OSS).
Time frame: Change from Baseline OSS at 2 months.
Values from 0 (Better) to 4 (Worse)
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 12 May 2023.
- Background: PubMed 29074306Murphy O, O'Dwyer V, Lloyd-McKernan A. The efficacy of tea tree face wash, 1, 2-Octanediol and microblepharoexfoliation in treating Demodex folliculorum blepharitis. Cont Lens Anterior Eye. 2018 Feb;41(1):77-82. doi: 10.1016/j.clae.2017.10.012. Epub 2017 Oct 23.
- Background: PubMed 35439775Mohammad-Rabei H, Arabi A, Shahraki T, Rezaee-Alam Z, Baradaran-Rafii A. Role of Blepharoexfoliation in Demodex Blepharitis: A Randomized Comparative Study. Cornea. 2023 Jan 1;42(1):44-51. doi: 10.1097/ICO.0000000000003046. Epub 2022 Apr 13.
- Background: PubMed 31939919Epstein IJ, Rosenberg E, Stuber R, Choi MB, Donnenfeld ED, Perry HD. Double-Masked and Unmasked Prospective Study of Terpinen-4-ol Lid Scrubs With Microblepharoexfoliation for the Treatment of Demodex Blepharitis. Cornea. 2020 Apr;39(4):408-416. doi: 10.1097/ICO.0000000000002243.
- Background: PubMed 30801507Siddireddy JS, Tan J, Vijay AK, Willcox MDP. The Effect of Microblepharon Exfoliation on Clinical Correlates of Contact Lens Discomfort. Optom Vis Sci. 2019 Mar;96(3):187-199. doi: 10.1097/OPX.0000000000001354.
- Background: PubMed 31941589Sambhi RS, Sambhi GDS, Mather R, Malvankar-Mehta MS. Intense pulsed light therapy with meibomian gland expression for dry eye disease. Can J Ophthalmol. 2020 Jun;55(3):189-198. doi: 10.1016/j.jcjo.2019.11.009. Epub 2020 Jan 13.
- Background: PubMed 32725403Leng X, Shi M, Liu X, Cui J, Sun H, Lu X. Intense pulsed light for meibomian gland dysfunction: a systematic review and meta-analysis. Graefes Arch Clin Exp Ophthalmol. 2021 Jan;259(1):1-10. doi: 10.1007/s00417-020-04834-1. Epub 2020 Jul 28.
- Background: PubMed 36044829Miao S, Yan R, Jia Y, Pan Z. Effect of Intense Pulsed Light Therapy in Dry Eye Disease Caused by Meibomian Gland Dysfunction: A Systematic Review and Meta-Analysis. Eye Contact Lens. 2022 Oct 1;48(10):424-429. doi: 10.1097/ICL.0000000000000934. Epub 2022 Sep 5.
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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.
Antonio Ballesteros Sánchez principal investigator
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microblepharoexfoliation, Intense pulse light and Meibomian gland expression in people with Dry Eye Disease, run by University of Seville at 1 site in Spain.
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 3 inclusion and 5 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 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Ocular surface disease index (OSDI) questionnaire. (time frame: Change from Baseline OSDI at 2 months.). The study lists 11 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 NCT05857579, which also lists 7 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 12 May 2023.