Dry Eye, Dry Eye After LASIK-Laser in Situ Keratomileusis
Conditions
Keywords
dry eye, laser refractive surgery, smile, lasik, presbylasik, photorefractive keratectomy, intense-pulsed light, low-level-light therapy, photobiomodulation
Brief summary
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.
Detailed description
monocentric, randomized, simple bling, controlled study
Interventions
DEVICEIPL+LLLT
preventive treatment by IPL+LLLT (EYE-LIGHT) before laser refractive surgery
Sponsors
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Intervention model description
Treatment group = LLLT+IPL (EYE-LIGHT) before laser refractive surgery
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patients eligible for laser corneal refractive surgery (FS-LASIK, SMILE®, or PRK) who meet the inclusion criteria will be enrolled.
Exclusion criteria
include age \< 18 and contraindications to IPL or LLLT (e.g., pregnancy, lactation, migraine, epilepsy, palpebral or periocular lesion, photosensitive drugs, cardiac pacing system or implantable cardiovertor defibrillator, Fitzpatrick phototypes V and VI).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| French version of 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
| Measure | Time frame | Description |
|---|---|---|
| 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 Meibomian Gland Dropout over the 6 first months post-operative | 6 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). |
| 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 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 |
| Evolution of the French version of 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. |
| 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. |
Countries
France
Outcome results
None listed