TEBELID: Combined Treatment With Pulsed Light and Photobiomodulation Before Laser Refractive Surgery

Sponsor

University Hospital, Brest (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05803798

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Dry Eye After LASIK-Laser in Situ Keratomileusis	Device: IPL+LLLT	N/A

Detailed Description

monocentric, randomized, simple bling, controlled study

Study Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Treatment group = LLLT+IPL (EYE-LIGHT) before laser refractive surgeryTreatment group = LLLT+IPL (EYE-LIGHT) before laser refractive surgery

Masking:

Double (Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Combined Treatment With Pulsed Light and Photobiomodulation Before Laser Refractive Surgery

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: treatment

preventive treatment by IPL+LLLT with EYE-LIGHT, Espansione group

Device: IPL+LLLT

preventive treatment by IPL+LLLT (EYE-LIGHT) before laser refractive surgery

No Intervention: standard

non preventive treatment by IPL+LLLT with EYE-LIGHT, Espansione group = standard care

Outcome Measures

Primary Outcome Measures

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

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 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 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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)