Combined Treatment With Pulsed Light and Photobiomodulation Before Laser Refractive Surgery

Study Overview
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Brief Summary
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Ametropia is the first cause of reversible visual trouble. Recently, laser refractive surgery has increased in popularity. Unfortunately, dry eye is a common side effect, representing about 25% of patients after LASIK and 20% after SMILE. Even if symptoms are usually released by artificial tears, there can be very uncomfortable for patients, decrease productivity and quality of life and be the source of unsatisfaction after surgery. The goal of our study is to study the efficiency of a preventive associated treatment by intense-pulsed-light and low-level-light therapy with EYE-LIGHT® device before laser refractive surgery. Recent study confirmed the efficacity of this treatment in meibomian glund dysfunction, the predominant dry eye mecanism.

Detailed Description
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monocentric, randomized, simple bling, controlled study

Official Title
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Combined Treatment With Pulsed Light and Photobiomodulation Before Laser Refractive Surgery

Conditions
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Dry Eye, Dry Eye After LASIK-Laser in Situ Keratomileusis

Intervention / Treatment
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* Device: IPL+LLLT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ametropia without progression for almost one year pachymetry >480 um myopia < -8 dioptre hyperopia < +6 dioptre astigmatism < -5 dioptre Exclusion Criteria: other ocular disease (such as keratoconus, cataract, glaucoma, AMD, diabetic retinopathy, etc.) infectious or systemic pathology (e.g.: epilepsia, migraine) pregnancy, fitzpatrick V or VI (eye-light contraindication)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Treatment group = LLLT+IPL (EYE-LIGHT) before laser refractive surgery
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: treatment<br>preventive treatment by IPL+LLLT with EYE-LIGHT, Espansione group | Device: IPL+LLLT<br>* preventive treatment by IPL+LLLT (EYE-LIGHT) before laser refractive surgery<br>|
| No Intervention: standard<br>non preventive treatment by IPL+LLLT with EYE-LIGHT, Espansione group = standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Disease Index (OSDI) score | The OSDI questionnaire measures frequency of symptoms, environmental triggers and vision related quality of life. OSDI values range from 0 to 100. A score between 13 and 22 excluded indicates a medium intensity eye dryness. A score between 22 and 33 indicated a moderate intensity eye dryness. A score above 33 indicates a severe eye dryness. | 1 month post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of Fluorescein Break-up Time (FBUT) over the 6 first months post-operative | Sodium fluorescein eye drops is instilled in the eye to enhance visibility of the tear film measure tear film breakup time is. Selected cut-off value is 10 seconds. A score below 10 seconds favors dry eye. | 6 months post-operative | 
| Evolution of Schirmer I test over the 6 first months post-operative | The Schirmer I test, used without anesthesia, provides an estimation of stimulated reflex. Cut-off value used is <= 10 mm / 5 minutes. | 6 months post-operative | 
| Evolution of Meiboscore over the 6 first months post-operative | Measured by Lacriview II, Tear Sciences. Meiboscore correspond to loss of the meibomian glands which is scored using the following grades for each eyelid: 0 : no loss of meibomian glands; 1 : area loss was less than one-third of the total meibomian gland area; 2 : area loss was between one-third and two-thirds; 3 : area loss was more than two-thirds. | 6 months post-operative | 
| Evolution of the Oxford score over the 6 first months post-operative | The Oxford score is composed of 0 to V grades, dependent on intensity of punctate staining displayed. pictorially across a combination of the cornea and conjunctiva. | 6 months post-operative | 
| Evolution of visual acuity over the 6 first months post-operative | Visual acuity measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale. The ETDRS chart used 4 m as the standard testing distance and the Sloan family of 5 x 5 letters as the optotypes. | 6 months post-operative | 
| Evolution of the Ocular Surface Disease Index (OSDI) score over the 6 first months post-operative | The OSDI questionnaire measures frequency of symptoms, environmental triggers and vision related quality of life. OSDI values range from 0 to 100. A score between 13 and 22 excluded indicates a medium intensity eye dryness. A score between 22 and 33 indicated a moderate intensity eye dryness. A score above 33 indicates a severe eye dryness. | 6 months post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry eye, laser refractive surgery, smile, lasik, presbylasik, photorefractive keratectomy, intense-pulsed light, low-level-light therapy, photobiomodulation