Laser corneal refractive surgery is a widely adopted approach for correcting refractive errors, but postoperative dry eye remains a common side effect. Intense Pulsed Light (IPL) and Low-Level Light Therapy (LLLT) are two emerging treatments that have shown potential in managing dry eye disease. However, their role as a prophylactic treatment in patients without pre-existing symptomatic dry eye undergoing refractive surgery has not been explored.
monocentric, randomized, simple bling, controlled study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
62
preventive treatment by IPL+LLLT (EYE-LIGHT) before laser refractive surgery
CHU Brest
Brest, France
French version of 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.
Time frame: 1 month post-operative
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.
Time frame: 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.
Time frame: 6 months post-operative
Evolution of Meibomian Gland Dropout over the 6 first months post-operative
Meibomian Gland Dropout: Evaluated via infrared images using LipiView™ II (Quantel Medical) and graded using the Gestalt Grading Scale (GGS), which scores meibomian gland loss on a scale from 1 (no loss) to 4 (\>75% loss).
Time frame: 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.
Time frame: 6 months post-operative
Evolution of visual acuity over the 6 first months post-operative
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Visual acuity measured preoperatively (corrected) and postoperatively (uncorrected) using the Early Treatment of Diabetic Retinopathy Study (ETDRS) scale at 4 meters. Visual acuity is scored by adding 30 to the total number of letters read correctly at 4 meters
Time frame: 6 months post-operative
Evolution of the French version of 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.
Time frame: 6 months post-operative