Combined Treatment With Pulsed Light and Photobiomodulation Before Laser Refractive Surgery
- Conditions
- Dry EyeDry Eye After LASIK-Laser in Situ Keratomileusis
- Interventions
- Device: IPL+LLLT
- Registration Number
- NCT05803798
- Lead Sponsor
- University Hospital, Brest
- Brief Summary
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
monocentric, randomized, simple bling, controlled study
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- ametropia without progression for almost one year
- pachymetry >480 um
- myopia < -8 dioptre
- hyperopia < +6 dioptre
- astigmatism < -5 dioptre
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description treatment IPL+LLLT preventive treatment by IPL+LLLT with EYE-LIGHT, Espansione group
- Primary Outcome Measures
Name Time Method Ocular Surface Disease Index (OSDI) score 1 month 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.
- Secondary Outcome Measures
Name Time Method Evolution of Fluorescein Break-up Time (FBUT) over the 6 first months post-operative 6 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.
Evolution of visual acuity over the 6 first months post-operative 6 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.
Evolution of Schirmer I test over the 6 first months post-operative 6 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.
Evolution of Meiboscore over the 6 first months post-operative 6 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.Evolution of the Oxford score over the 6 first months post-operative 6 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.Evolution of the Ocular Surface Disease Index (OSDI) score over the 6 first months post-operative 6 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.
Trial Locations
- Locations (1)
CHU Brest
🇫🇷Brest, France