Meibomian Gland DysfunctionNCT05139511
Analysis of the Results of Intense Pulsed Light Treatment Previously to Laser Refractive Surgery
A study testing Study group in people with Meibomian Gland Dysfunction and Blepharitis, run by Vissum, Instituto Oftalmológico de Alicante at 1 site in Spain.
Trial summary
Dry eye is often reported as the most common complication after a laser refractive surgery. Any refractive procedure can lead an impact on the corneal surface and the tear film. The main cause of this dry eye is the corneal denervation caused by the destruction of the anterior stromal nerves during the ablative… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Meibomian Gland Dysfunction, Blepharitis
- What is being tested?
- Study group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2021to 15 Aug 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients over 18 years of age who are undergoing a corneal laser refractive surgery after a medical indication by the Vissum ophthalmologist
Who cannot join
- Pregnancy
- Piercings
- Fitzpatrick skin classification V and VI
- Autoimmune diseases
- Epilepsy
- Previous history of herpes or ocular pathology
- Pathological or suspicious corneal topography
- Treatment in the previous month with corticosteroids, antihistamines or topical vasoconstrictors.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Alicante Vissum Miranza
Alicante, 03016
Alejandra E Rodriguez, MSc, PhD, 965154062 ext. +34, clinicaltrials@vissum.com
About this study
Official title: Analysis of the Efficacy and Safety of Intense Pulsed Light Treatment for the Ocular Surface in Patients Who Will Undergo Laser Refractive Surgery
Dry eye is often reported as the most common complication after a laser refractive surgery. Any refractive procedure can lead an impact on the corneal surface and the tear film.
The main cause of this dry eye is the corneal denervation caused by the destruction of the anterior stromal nerves during the ablative procedure. This loss of corneal sensitivity leads to a decrease in the blink reflex, a decrease in the secretion rate of the meibomian glands and finally an evaporated dry eye. There is also a chronic inflammation at the corneal surface that produces an increase of inflammatory cytokines and a dysfunction of the meibomian glands.
Read more
Yu et al have described incidences of dry eye closed to 60% after the first month of LASIK. Hovanesian et al have observed dry eye symptoms in 50% of patients 6 months after surgery. Donnenfeld et al describe 15% of moderate dry eye in the following 3 months and 5% of severe dry eye in the first 6 months. A small number of patients will present with chronic dry eye symptoms for more than 1 year. Bower et al analyzed its incidence in 0.8% Alterations in the tear film also decrease the quality of the retinal image and produce greater number of high-order due to the irregular.
Pulsed light therapy (IPL) applied preoperatively in patients who undergo a laser refractive surgery may prevent the post-surgical dry eye and improve the refractive results. The aim of our study is to evaluate the usefulness of the applied therapy for the prevention of dry eye in patients that undergo a corneal refractive procedure.
Read the detailed description
- Design Clinical experimental controlled trial, double-blind in which participants will be randomized into 2 groups: a study group (IPL + laser refractive surgery) and a control group (laser refractive surgery without IPL). The study will be conducted in accordance with Law 14/2007 of 3 July, on Biomedical Research, the Declaration of Helsinki (October 2013 version), standards of Good Clinical Practice and legislation in this area. All participants included in the study should read the Information Sheet and sign the informed and voluntary consent.
- Participants Participants from Vissum Clinic that present the inclusion criteria and none of the exclusion criteria. The investigators will start the study with a preliminary project and depending on the results obtained, the investigators will apply these values to calculate the final sample size using the T-student-Fischer test for unilateral hypotheses and for a type 1 or α error of 5%. and a type 2 or β error of 20%.
- Parameters evaluated Primary measures: age, sex, skin phototype, visual acuity with and without correction, refraction, cycloplegic refraction, OSDI and VAS questionnaire, use of artificial tears, oxford scale, lacrimal meniscus height, tear break-up time, conjunctival hyperemia, meibography and slit lamp examination. Secondary measures: corneal topography and tomography (MS-39, CSO, Italy), corneal aberrometry (MS-39, CSO, Italy), ocular aberrometry (Osiris, CSO, Italy), analysis of contrast sensitivity (CSV-1000, Vector vision), photographic capture of the epithelial defect in PRK, pre-surgical and postsurgical photographic capture of the eyelid changes in PRK. The measurement of the different objective variables will be carried out in the clinic. The measurement of the subjective variables will be carried out by two ophthalmologists, both masked.
- Surgery and follow-up Participants who are candidates for a LASIK or SMILE procedure will receive, after randomization, IPL treatment in both eyes (experimental group) or sham IPL (control group). In the case of participant candidate for a PRK procedure, an intra-subject control group will be used, where one eye will receive the IPL treatment (right eyes) and the left contralateral eye the sham IPL treatment (control). Refractive surgeries will be performed exclusively two ophthalmologists following the same surgical protocol. IPL therapy (M22, Lumenis LTD, Israel) will be performed following the same protocol (standardized facial and periocular application with automatically adjusted energy according to Fitzpatrick skin classification). Three IPL sessions will be applied (simulated in the case of the control group): 7 days before the intervention, 7 days after the intervention, and 30 days after the intervention. The total postsurgical follow-up will be 6 months.
- Statistical analyses All demographic and clinical data will be collected in a database and analyzed with the SPSS statistical package for Windows version 22.0. A p <0.05% will be considered significant.
- Conditions
- Meibomian Gland Dysfunction, Blepharitis
- Being tested
- Study group, Control group
- Keywords
- Intense pulsed light, LASIK / SMILE
- Medical subject headings
- Meibomian Gland Dysfunction, Blepharitis, Smiling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study groupDevice
Also called Intense pulsed light therapy (Lumenis M22)
The IPL therapy consists in a polychromatic pulses of light not coherent and not collimated. The therapy leads to a series of processes such as the destruction of superficial blood vessels and thus the reduction of local inflammation, the liquefy of the meibum and an antimicrobial, anti-inflammatory and antioxidant effects. The therapy is performed over the cheeks, nose and upper eyelids.
Control groupOther
Same procedure but without energy
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | IPL + laser refractive surgery Receives: Device: Study group |
| Control group | Placebo comparator | Laser refractive surgery without IPL Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI questionnaire
It measures the severity of ocular surface symptoms and includes 12 items organized into 3 subscales; eye discomfort, functionality and environmental factors. After completing the questionnaire, a final score is obtained that when it is higher than 13 indicates ocular surface pathology.
Measured: 0 day
Change from Baseline OSDI questionnaire
It measures the severity of ocular surface symptoms and includes 12 items organized into 3 subscales; eye discomfort, functionality and environmental factors. After completing the questionnaire, a final score is obtained that when it is higher than 13 indicates ocular surface pathology.
Measured: 7 day
Change from Baseline OSDI questionnaire
It measures the severity of ocular surface symptoms and includes 12 items organized into 3 subscales; eye discomfort, functionality and environmental factors. After completing the questionnaire, a final score is obtained that when it is higher than 13 indicates ocular surface pathology.
Measured: 30 day
Change from Baseline OSDI questionnaire
It measures the severity of ocular surface symptoms and includes 12 items organized into 3 subscales; eye discomfort, functionality and environmental factors. After completing the questionnaire, a final score is obtained that when it is higher than 13 indicates ocular surface pathology.
Measured: 90 day
Change from Baseline OSDI questionnaire
It measures the severity of ocular surface symptoms and includes 12 items organized into 3 subscales; eye discomfort, functionality and environmental factors. After completing the questionnaire, a final score is obtained that when it is higher than 13 indicates ocular surface pathology.
Measured: 180 day
Lacrimal meniscus height
Measured in millimeters by Ocular Keratograph 5M, a value greater than 0.20 mm is considered normal
Measured: 0 day
Change from Baseline Lacrimal meniscus height
Measured in millimeters, a value greater than 0.20 mm is considered normal
Measured: 7 day
Change from Baseline Lacrimal meniscus height
Measured in millimeters, a value greater than 0.20 mm is considered normal
Measured: 30 day
Change from Baseline Lacrimal meniscus height
Measured in millimeters, a value greater than 0.20 mm is considered normal
Measured: 90 day
Change from Baseline Lacrimal meniscus height
Measured in millimeters, a value greater than 0.20 mm is considered normal
Measured: 180 day
Tear Break-up-time
Time elapsed from the last blink to the appearance of the first tear discontinuity measured by Ocular Keratograph 5M. A title longer than 5 seconds is considered normal.
Measured: 0 day
Change from Baseline Tear Break-up-time
time elapsed from the last blink to the appearance of the first tear discontinuity measured by Ocular Keratograph 5M. A title longer than 5 seconds is considered normal.
Measured: 7 day
Change from Baseline Tear Break-up-time
time elapsed from the last blink to the appearance of the first tear discontinuity measured by Ocular Keratograph 5M. A title longer than 5 seconds is considered normal.
Measured: 30 day
Change from Baseline Tear Break-up-time
time elapsed from the last blink to the appearance of the first tear discontinuity measured by Ocular Keratograph 5M. A title longer than 5 seconds is considered normal.
Measured: 90 day
Change from Baseline Tear Break-up-time
time elapsed from the last blink to the appearance of the first tear discontinuity measured by Ocular Keratograph 5M. A title longer than 5 seconds is considered normal.
Measured: 180 day
Conjunctival and ciliary hyperemia.
Grade of red eye measured by Ocular Keratograph 5M. Jenvis ranking from 0 to 4 (normal, mild, moderate, severe)
Measured: 0 day
Change from Baseline Conjunctival and ciliary hyperemia.
Grade of red eye measured by Ocular Keratograph 5M. Jenvis ranking from 0 to 4 (normal, mild, moderate, severe)
Measured: 7 day
Change from Baseline Conjunctival and ciliary hyperemia.
Grade of red eye measured by Ocular Keratograph 5M. Jenvis ranking from 0 to 4 (normal, mild, moderate, severe)
Measured: 30 day
Change from Baseline Conjunctival and ciliary hyperemia.
Grade of red eye measured by Ocular Keratograph 5M. Jenvis ranking from 0 to 4 (normal, mild, moderate, severe)
Measured: 90 day
Change from Baseline Conjunctival and ciliary hyperemia.
Grade of red eye measured by Ocular Keratograph 5M. Jenvis ranking from 0 to 4 (normal, mild, moderate, severe)
Measured: 180 day
Upper and lower meibography
Measured by Oculus Keratograph 5M. Observes and evaluates morphological changes of the meibomian glands Meiboscore classification
- Grade 0: no loss of meibomian glands.
- Grade 1: loss of less than 1/3 of the total surface of the meibomian glands.
- Grade 2: loss of 1/3 to 2/3 of the total area.
- Grade 3: loss of more than 2/3 of the surface.
Measured: 0 day
Change from Baseline Upper and lower meibography
Measured by Oculus Keratograph 5M. Observes and evaluates morphological changes of the meibomian glands Meiboscore classification
- Grade 0: no loss of meibomian glands.
- Grade 1: loss of less than 1/3 of the total surface of the meibomian glands.
- Grade 2: loss of 1/3 to 2/3 of the total area.
- Grade 3: loss of more than 2/3 of the surface.
Measured: 7 day
Change from Baseline Upper and lower meibography
Measured by Oculus Keratograph 5M. Observes and evaluates morphological changes of the meibomian glands Meiboscore classification
- Grade 0: no loss of meibomian glands.
- Grade 1: loss of less than 1/3 of the total surface of the meibomian glands.
- Grade 2: loss of 1/3 to 2/3 of the total area.
- Grade 3: loss of more than 2/3 of the surface.
Measured: 30 day
Change from Baseline Upper and lower meibography
Measured by Oculus Keratograph 5M. Observes and evaluates morphological changes of the meibomian glands Meiboscore classification
- Grade 0: no loss of meibomian glands.
- Grade 1: loss of less than 1/3 of the total surface of the meibomian glands.
- Grade 2: loss of 1/3 to 2/3 of the total area.
- Grade 3: loss of more than 2/3 of the surface.
Measured: 90 day
Change from Baseline Upper and lower meibography
Measured by Oculus Keratograph 5M. Observes and evaluates morphological changes of the meibomian glands Meiboscore classification
- Grade 0: no loss of meibomian glands.
- Grade 1: loss of less than 1/3 of the total surface of the meibomian glands.
- Grade 2: loss of 1/3 to 2/3 of the total area.
- Grade 3: loss of more than 2/3 of the surface.
Measured: 180 day
Secondary outcomes (10)
Visual acuity
Visual acuity with and without correction, measured on a decimal scale, determined by the Snellen panel, placing the examined person at a distance of 6 meters, will be collected by an optician.
Measured: 0 day
Change from Baseline Visual acuity
Visual acuity with and without correction, measured on a decimal scale, determined by the Snellen panel, placing the examined person at a distance of 6 meters, will be collected by an optician.
Measured: 180 day
Corneal topography
Performs an analysis of the cornea, which allows evaluating the shape and quantifying the power of the different curvatures
Measured: 0 day
Change from Baseline Corneal topography
Performs an analysis of the cornea, which allows evaluating the shape and quantifying the power of the different curvatures
Measured: 180 day
Corneal aberrometry
Technique that analyzes complex systems of light waves to quantify the set of optical aberrations that exist within the ocular structure.
Measured: 0 day
Change from Baseline Corneal aberrometry
Technique that analyzes complex systems of light waves to quantify the set of optical aberrations that exist within the ocular structure.
Measured: 180 day
Analysis of contrast sensitivity
Contrast Sensitivity is a test that assesses a person's ability to identify an object and separate it from the background Contrast sensitivity is evaluated with charts that can be used as projected or wall acuity charts.
Measured: 0 day
Change from Baseline Analysis of contrast sensitivity
Contrast Sensitivity is a test that assesses a person's ability to identify an object and separate it from the background Contrast sensitivity is evaluated with charts that can be used as projected or wall acuity charts.
Measured: 180 day
VAS questionnaire
investigates the intensity of the ocular surface symptoms from 0 to 100 (normal- severe)
Measured: 0 day
Change from Baseline VAS questionnaire
investigates the intensity of the ocular surface symptoms from 0 to 100 (normal- severe)
Measured: 180 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start15 Feb 2021
- Primary completion15 Apr 2023 (estimated)
- Study completion15 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Meibomian Gland DysfunctionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical experimental controlled trial, double-blind in which participants will be randomized into 2 groups: a study group and a control group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vissum, Instituto Oftalmológico de Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorge Alió del Barrio, MD, PhD, Principal investigator, Vissum MiranzaMaria Martinez Hergueta, MD, Study chair, Universidad Miguel HernándezMaria A Amesty, MD, PhD, Study chair, Vissum MiranzaMario Cantó Cerdan, MSc, Study chair, Vissum MiranzaAlejandra Rodriguez, MSc, PhD, Study chair, Vissum MiranzaJorge L Alió y Sanz, MD, PhD, Study chair, Vissum Miranza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139511
- Sponsor's protocol ID
- IPL-2020
- Status last verified
- Oct 2022
- First submitted
- 4 Nov 2021
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be anonymized by assigning a code file and only authorized personnel will have access to personally identifiable data. The highest levels of professional conduct and confidentiality will always be maintained, complying with Organic Law 3/2018, of December 5, on the Protection of Personal Data and guarantee of digital rights.
Publications
Solomon R, Donnenfeld ED, Perry HD. The effects of LASIK on the ocular surface. Ocul Surf. 2004 Jan;2(1):34-44. doi: 10.1016/s1542-0124(12)70022-8.
PubMed 17216074Toda I. Dry Eye After LASIK. Invest Ophthalmol Vis Sci. 2018 Nov 1;59(14):DES109-DES115. doi: 10.1167/iovs.17-23538.
PubMed 30481814Ge J, Liu N, Wang X, Du Y, Wang C, Li Z, Li J, Wang L. Evaluation of the efficacy of optimal pulsed technology treatment in patients with cataract and Meibomian gland dysfunction in the perioperative period. BMC Ophthalmol. 2020 Mar 18;20(1):111. doi: 10.1186/s12886-020-01357-5.
PubMed 32188437Jung JW, Han SJ, Nam SM, Kim TI, Kim EK, Seo KY. Meibomian gland dysfunction and tear cytokines after cataract surgery according to preoperative meibomian gland status. Clin Exp Ophthalmol. 2016 Sep;44(7):555-562. doi: 10.1111/ceo.12744. Epub 2016 May 1.
PubMed 26989003Yu EY, Leung A, Rao S, Lam DS. Effect of laser in situ keratomileusis on tear stability. Ophthalmology. 2000 Dec;107(12):2131-5. doi: 10.1016/s0161-6420(00)00388-2.
PubMed 11097583Hovanesian JA, Shah SS, Maloney RK. Symptoms of dry eye and recurrent erosion syndrome after refractive surgery. J Cataract Refract Surg. 2001 Apr;27(4):577-84. doi: 10.1016/s0886-3350(00)00835-x.
PubMed 11311627Nettune GR, Pflugfelder SC. Post-LASIK tear dysfunction and dysesthesia. Ocul Surf. 2010 Jul;8(3):135-45. doi: 10.1016/s1542-0124(12)70224-0.
PubMed 20712970Cote S, Zhang AC, Ahmadzai V, Maleken A, Li C, Oppedisano J, Nair K, Busija L, Downie LE. Intense pulsed light (IPL) therapy for the treatment of meibomian gland dysfunction. Cochrane Database Syst Rev. 2020 Mar 18;3(3):CD013559. doi: 10.1002/14651858.CD013559.
PubMed 32182637Rong B, Tang Y, Tu P, Liu R, Qiao J, Song W, Toyos R, Yan X. Intense Pulsed Light Applied Directly on Eyelids Combined with Meibomian Gland Expression to Treat Meibomian Gland Dysfunction. Photomed Laser Surg. 2018 Jun;36(6):326-332. doi: 10.1089/pho.2017.4402. Epub 2018 Apr 24.
PubMed 29688838
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Efficacy and Safety of Intense Pulsed Light Treatment for the Ocular Surface in Patients Who Will Undergo Laser Refractive Surgery
- ClinicalTrials.gov ID
- NCT05139511
- Acronym / sponsor ID
- IPL-2020
- Conditions
- Meibomian Gland Dysfunction, Blepharitis
- Keywords
- Intense pulsed light, LASIK / SMILE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Vissum, Instituto Oftalmológico de AlicanteUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 1 Dec 2021 (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.
Dry eye is often reported as the most common complication after a laser refractive surgery. Any refractive procedure can lead an impact on the corneal surface and the tear film.
The main cause of this dry eye is the corneal denervation caused by the destruction of the anterior stromal nerves during the ablative procedure. This loss of corneal sensitivity leads to a decrease in the blink reflex, a decrease in the secretion rate of the meibomian glands and finally an evaporated dry eye. There is also a chronic inflammation at the corneal surface that produces an increase of inflammatory cytokines and a dysfunction of the meibomian glands.
Yu et al have described incidences of dry eye closed to 60% after the first month of LASIK. Hovanesian et al have observed dry eye symptoms in 50% of patients 6 months after surgery. Donnenfeld et al describe 15% of moderate dry eye in the following 3 months and 5% of severe dry eye in the first 6 months. A small number of patients will present with chronic dry eye symptoms for more than 1 year. Bower et al analyzed its incidence in 0.8% Alterations in the tear film also decrease the quality of the retinal image and produce greater number of high-order due to the irregular.
Pulsed light therapy (IPL) applied preoperatively in patients who undergo a laser refractive surgery may prevent the post-surgical dry eye and improve the refractive results. The aim of our study is to evaluate the usefulness of the applied therapy for the prevention of dry eye in patients that undergo a corneal refractive procedure.
Detailed description
- Design Clinical experimental controlled trial, double-blind in which participants will be randomized into 2 groups: a study group (IPL + laser refractive surgery) and a control group (laser refractive surgery without IPL). The study will be conducted in accordance with Law 14/2007 of 3 July, on Biomedical Research, the Declaration of Helsinki (October 2013 version), standards of Good Clinical Practice and legislation in this area. All participants included in the study should read the Information Sheet and sign the informed and voluntary consent.
- Participants Participants from Vissum Clinic that present the inclusion criteria and none of the exclusion criteria. The investigators will start the study with a preliminary project and depending on the results obtained, the investigators will apply these values to calculate the final sample size using the T-student-Fischer test for unilateral hypotheses and for a type 1 or α error of 5%. and a type 2 or β error of 20%.
- Parameters evaluated Primary measures: age, sex, skin phototype, visual acuity with and without correction, refraction, cycloplegic refraction, OSDI and VAS questionnaire, use of artificial tears, oxford scale, lacrimal meniscus height, tear break-up time, conjunctival hyperemia, meibography and slit lamp examination. Secondary measures: corneal topography and tomography (MS-39, CSO, Italy), corneal aberrometry (MS-39, CSO, Italy), ocular aberrometry (Osiris, CSO, Italy), analysis of contrast sensitivity (CSV-1000, Vector vision), photographic capture of the epithelial defect in PRK, pre-surgical and postsurgical photographic capture of the eyelid changes in PRK. The measurement of the different objective variables will be carried out in the clinic. The measurement of the subjective variables will be carried out by two ophthalmologists, both masked.
- Surgery and follow-up Participants who are candidates for a LASIK or SMILE procedure will receive, after randomization, IPL treatment in both eyes (experimental group) or sham IPL (control group). In the case of participant candidate for a PRK procedure, an intra-subject control group will be used, where one eye will receive the IPL treatment (right eyes) and the left contralateral eye the sham IPL treatment (control). Refractive surgeries will be performed exclusively two ophthalmologists following the same surgical protocol. IPL therapy (M22, Lumenis LTD, Israel) will be performed following the same protocol (standardized facial and periocular application with automatically adjusted energy according to Fitzpatrick skin classification). Three IPL sessions will be applied (simulated in the case of the control group): 7 days before the intervention, 7 days after the intervention, and 30 days after the intervention. The total postsurgical follow-up will be 6 months.
- Statistical analyses All demographic and clinical data will be collected in a database and analyzed with the SPSS statistical package for Windows version 22.0. A p <0.05% will be considered significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Clinical experimental controlled trial, double-blind in which participants will be randomized into 2 groups: a study group and a control group
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Study groupIPL + laser refractive surgery |
| Control group | Placebo comparator | Other: Control groupLaser refractive surgery without IPL |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients over 18 years of age who are undergoing a corneal laser refractive surgery after a medical indication by the Vissum ophthalmologist
Key exclusion criteria (8 listed)
- Pregnancy
- Piercings
- Fitzpatrick skin classification V and VI
- Autoimmune diseases
- Epilepsy
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 |
|---|---|---|
| Study groupAlso: Intense pulsed light therapy (Lumenis M22)The IPL therapy consists in a polychromatic pulses of light not coherent and not collimated. The therapy leads to a series of processes such as the destruction of superficial blood vessels and thus the reduction of local inflammation, the liquefy of the meibum and an antimicrobial, anti-inflammatory and antioxidant effects. The therapy is performed over the cheeks, nose and upper eyelids. | Device | Study group |
| Control groupSame procedure but without energy | Other | Control group |
Primary outcome
OSDI questionnaire
Time frame: 0 day
It measures the severity of ocular surface symptoms and includes 12 items organized into 3 subscales; eye discomfort, functionality and environmental factors. After completing the questionnaire, a final score is obtained that when it is higher than 13 indicates ocular surface pathology.
Change from Baseline OSDI questionnaire
Time frame: 7 day
It measures the severity of ocular surface symptoms and includes 12 items organized into 3 subscales; eye discomfort, functionality and environmental factors. After completing the questionnaire, a final score is obtained that when it is higher than 13 indicates ocular surface pathology.
Change from Baseline OSDI questionnaire
Time frame: 30 day
It measures the severity of ocular surface symptoms and includes 12 items organized into 3 subscales; eye discomfort, functionality and environmental factors. After completing the questionnaire, a final score is obtained that when it is higher than 13 indicates ocular surface pathology.
Change from Baseline OSDI questionnaire
Time frame: 90 day
It measures the severity of ocular surface symptoms and includes 12 items organized into 3 subscales; eye discomfort, functionality and environmental factors. After completing the questionnaire, a final score is obtained that when it is higher than 13 indicates ocular surface pathology.
Change from Baseline OSDI questionnaire
Time frame: 180 day
It measures the severity of ocular surface symptoms and includes 12 items organized into 3 subscales; eye discomfort, functionality and environmental factors. After completing the questionnaire, a final score is obtained that when it is higher than 13 indicates ocular surface pathology.
Lacrimal meniscus height
Time frame: 0 day
Measured in millimeters by Ocular Keratograph 5M, a value greater than 0.20 mm is considered normal
Change from Baseline Lacrimal meniscus height
Time frame: 7 day
Measured in millimeters, a value greater than 0.20 mm is considered normal
Change from Baseline Lacrimal meniscus height
Time frame: 30 day
Measured in millimeters, a value greater than 0.20 mm is considered normal
Change from Baseline Lacrimal meniscus height
Time frame: 90 day
Measured in millimeters, a value greater than 0.20 mm is considered normal
Change from Baseline Lacrimal meniscus height
Time frame: 180 day
Measured in millimeters, a value greater than 0.20 mm is considered normal
Tear Break-up-time
Time frame: 0 day
Time elapsed from the last blink to the appearance of the first tear discontinuity measured by Ocular Keratograph 5M. A title longer than 5 seconds is considered normal.
Change from Baseline Tear Break-up-time
Time frame: 7 day
time elapsed from the last blink to the appearance of the first tear discontinuity measured by Ocular Keratograph 5M. A title longer than 5 seconds is considered normal.
Change from Baseline Tear Break-up-time
Time frame: 30 day
time elapsed from the last blink to the appearance of the first tear discontinuity measured by Ocular Keratograph 5M. A title longer than 5 seconds is considered normal.
Change from Baseline Tear Break-up-time
Time frame: 90 day
time elapsed from the last blink to the appearance of the first tear discontinuity measured by Ocular Keratograph 5M. A title longer than 5 seconds is considered normal.
Change from Baseline Tear Break-up-time
Time frame: 180 day
time elapsed from the last blink to the appearance of the first tear discontinuity measured by Ocular Keratograph 5M. A title longer than 5 seconds is considered normal.
Conjunctival and ciliary hyperemia.
Time frame: 0 day
Grade of red eye measured by Ocular Keratograph 5M. Jenvis ranking from 0 to 4 (normal, mild, moderate, severe)
Change from Baseline Conjunctival and ciliary hyperemia.
Time frame: 7 day
Grade of red eye measured by Ocular Keratograph 5M. Jenvis ranking from 0 to 4 (normal, mild, moderate, severe)
Change from Baseline Conjunctival and ciliary hyperemia.
Time frame: 30 day
Grade of red eye measured by Ocular Keratograph 5M. Jenvis ranking from 0 to 4 (normal, mild, moderate, severe)
Change from Baseline Conjunctival and ciliary hyperemia.
Time frame: 90 day
Grade of red eye measured by Ocular Keratograph 5M. Jenvis ranking from 0 to 4 (normal, mild, moderate, severe)
Change from Baseline Conjunctival and ciliary hyperemia.
Time frame: 180 day
Grade of red eye measured by Ocular Keratograph 5M. Jenvis ranking from 0 to 4 (normal, mild, moderate, severe)
Upper and lower meibography
Time frame: 0 day
Measured by Oculus Keratograph 5M. Observes and evaluates morphological changes of the meibomian glands Meiboscore classification * Grade 0: no loss of meibomian glands. * Grade 1: loss of less than 1/3 of the total surface of the meibomian glands. * Grade 2: loss of 1/3 to 2/3 of the total area. * Grade 3: loss of more than 2/3 of the surface.
Change from Baseline Upper and lower meibography
Time frame: 7 day
Measured by Oculus Keratograph 5M. Observes and evaluates morphological changes of the meibomian glands Meiboscore classification * Grade 0: no loss of meibomian glands. * Grade 1: loss of less than 1/3 of the total surface of the meibomian glands. * Grade 2: loss of 1/3 to 2/3 of the total area. * Grade 3: loss of more than 2/3 of the surface.
Change from Baseline Upper and lower meibography
Time frame: 30 day
Measured by Oculus Keratograph 5M. Observes and evaluates morphological changes of the meibomian glands Meiboscore classification * Grade 0: no loss of meibomian glands. * Grade 1: loss of less than 1/3 of the total surface of the meibomian glands. * Grade 2: loss of 1/3 to 2/3 of the total area. * Grade 3: loss of more than 2/3 of the surface.
Change from Baseline Upper and lower meibography
Time frame: 90 day
Measured by Oculus Keratograph 5M. Observes and evaluates morphological changes of the meibomian glands Meiboscore classification * Grade 0: no loss of meibomian glands. * Grade 1: loss of less than 1/3 of the total surface of the meibomian glands. * Grade 2: loss of 1/3 to 2/3 of the total area. * Grade 3: loss of more than 2/3 of the surface.
Change from Baseline Upper and lower meibography
Time frame: 180 day
Measured by Oculus Keratograph 5M. Observes and evaluates morphological changes of the meibomian glands Meiboscore classification * Grade 0: no loss of meibomian glands. * Grade 1: loss of less than 1/3 of the total surface of the meibomian glands. * Grade 2: loss of 1/3 to 2/3 of the total area. * Grade 3: loss of more than 2/3 of the surface.
10 secondary outcomes
Visual acuity
Time frame: 0 day
Change from Baseline Visual acuity
Time frame: 180 day
Corneal topography
Time frame: 0 day
Change from Baseline Corneal topography
Time frame: 180 day
Corneal aberrometry
Time frame: 0 day
Change from Baseline Corneal aberrometry
Time frame: 180 day
Analysis of contrast sensitivity
Time frame: 0 day
Change from Baseline Analysis of contrast sensitivity
Time frame: 180 day
VAS questionnaire
Time frame: 0 day
Change from Baseline VAS questionnaire
Time frame: 180 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Results publication: PubMed 17216074Solomon R, Donnenfeld ED, Perry HD. The effects of LASIK on the ocular surface. Ocul Surf. 2004 Jan;2(1):34-44. doi: 10.1016/s1542-0124(12)70022-8.
- Results publication: PubMed 30481814Toda I. Dry Eye After LASIK. Invest Ophthalmol Vis Sci. 2018 Nov 1;59(14):DES109-DES115. doi: 10.1167/iovs.17-23538.
- Results publication: PubMed 32188437Ge J, Liu N, Wang X, Du Y, Wang C, Li Z, Li J, Wang L. Evaluation of the efficacy of optimal pulsed technology treatment in patients with cataract and Meibomian gland dysfunction in the perioperative period. BMC Ophthalmol. 2020 Mar 18;20(1):111. doi: 10.1186/s12886-020-01357-5.
- Results publication: PubMed 26989003Jung JW, Han SJ, Nam SM, Kim TI, Kim EK, Seo KY. Meibomian gland dysfunction and tear cytokines after cataract surgery according to preoperative meibomian gland status. Clin Exp Ophthalmol. 2016 Sep;44(7):555-562. doi: 10.1111/ceo.12744. Epub 2016 May 1.
- Results publication: PubMed 11097583Yu EY, Leung A, Rao S, Lam DS. Effect of laser in situ keratomileusis on tear stability. Ophthalmology. 2000 Dec;107(12):2131-5. doi: 10.1016/s0161-6420(00)00388-2.
- Results publication: PubMed 11311627Hovanesian JA, Shah SS, Maloney RK. Symptoms of dry eye and recurrent erosion syndrome after refractive surgery. J Cataract Refract Surg. 2001 Apr;27(4):577-84. doi: 10.1016/s0886-3350(00)00835-x.
- Results publication: PubMed 20712970Nettune GR, Pflugfelder SC. Post-LASIK tear dysfunction and dysesthesia. Ocul Surf. 2010 Jul;8(3):135-45. doi: 10.1016/s1542-0124(12)70224-0.
- Results publication: PubMed 32182637Cote S, Zhang AC, Ahmadzai V, Maleken A, Li C, Oppedisano J, Nair K, Busija L, Downie LE. Intense pulsed light (IPL) therapy for the treatment of meibomian gland dysfunction. Cochrane Database Syst Rev. 2020 Mar 18;3(3):CD013559. doi: 10.1002/14651858.CD013559.
- Results publication: PubMed 29688838Rong B, Tang Y, Tu P, Liu R, Qiao J, Song W, Toyos R, Yan X. Intense Pulsed Light Applied Directly on Eyelids Combined with Meibomian Gland Expression to Treat Meibomian Gland Dysfunction. Photomed Laser Surg. 2018 Jun;36(6):326-332. doi: 10.1089/pho.2017.4402. Epub 2018 Apr 24.
- Individual participant dataSharing planned: No. Data will be anonymized by assigning a code file and only authorized personnel will have access to personally identifiable data. The highest levels of professional conduct and confidentiality will always be maintained, complying with Organic Law 3/2018, of December 5, on the Protection of Personal Data and guarantee of digital rights.
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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.
Jorge Alió del Barrio, MD, PhD principal investigator
Vissum Miranza
Maria Martinez Hergueta, MD study chair
Universidad Miguel Hernández
Maria A Amesty, MD, PhD study chair
Vissum Miranza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study group in people with Meibomian Gland Dysfunction and Blepharitis, run by Vissum, Instituto Oftalmológico de Alicante 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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 18 Oct 2022. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Alió del Barrio, MD, PhD (965154062 ext. +34, jorge_alio@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSDI questionnaire (time frame: 0 day). The study lists 25 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 NCT05139511, which also lists 9 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 18 Oct 2022.