An interventional study of Study group and Control group in Meibomian Gland Dysfunction and Blepharitis, sponsored by Vissum, Instituto Oftalmológico de Alicante. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-18.
Sponsored by Vissum, Instituto Oftalmológico de Alicante · Not applicable, Interventional, and Prevention
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.
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.
172 studies on the registry are indexed under Meibomian Gland Dysfunction; 23 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 138 interventional studies indexed under Meibomian Gland Dysfunction.
Browse Meibomian Gland Dysfunction studies →Vissum, Instituto Oftalmológico de Alicante is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
IPL + laser refractive surgery
Device: Study group
Laser refractive surgery without IPL
Other: Control group
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.
Also known as: Intense pulsed light therapy (Lumenis M22)
Same procedure but without energy
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 180 day
Lacrimal meniscus height
Measured in millimeters by Ocular Keratograph 5M, a value greater than 0.20 mm is considered normal
Time frame: 0 day
Change from Baseline Lacrimal meniscus height
Measured in millimeters, a value greater than 0.20 mm is considered normal
Time frame: 7 day
Change from Baseline Lacrimal meniscus height
Measured in millimeters, a value greater than 0.20 mm is considered normal
Time frame: 30 day
Change from Baseline Lacrimal meniscus height
Measured in millimeters, a value greater than 0.20 mm is considered normal
Time frame: 90 day
Change from Baseline Lacrimal meniscus height
Measured in millimeters, a value greater than 0.20 mm is considered normal
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 180 day
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.
Time frame: 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.
Time frame: 180 day
Corneal topography
Performs an analysis of the cornea, which allows evaluating the shape and quantifying the power of the different curvatures
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 180 day
VAS questionnaire
investigates the intensity of the ocular surface symptoms from 0 to 100 (normal- severe)
Time frame: 0 day
Change from Baseline VAS questionnaire
investigates the intensity of the ocular surface symptoms from 0 to 100 (normal- severe)
Time frame: 180 day
Plan to share: 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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Vissum, Instituto Oftalmológico de Alicante