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OpenTrials
Completed

NCT Number: NCT05803798

Combined Treatment With Pulsed Light and Photobiomodulation Before Laser Refractive Surgery

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.

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Key information

Conditions

Dry Eye Behavior Communication Dry Eye After LASIK-Laser in Situ Keratomileusis Dry Eye Syndromes Eye Diseases Facial Expression Lacrimal Apparatus Diseases Nonverbal Communication Smiling

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brest

Brest, France

About this study

monocentric, randomized, simple bling, controlled study

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

IPL+LLLT

Device

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

Primary outcomes

  1. French version of Ocular Surface Disease Index (OSDI) score

    Time frame: 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 outcomes

  1. Evolution of Fluorescein Break-up Time (FBUT) over the 6 first months post-operative

    Time frame: 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.

  2. Evolution of Schirmer I test over the 6 first months post-operative

    Time frame: 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.

  3. Evolution of Meibomian Gland Dropout over the 6 first months post-operative

    Time frame: 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).

  4. Evolution of the Oxford score over the 6 first months post-operative

    Time frame: 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.

  5. Evolution of visual acuity over the 6 first months post-operative

    Time frame: 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

  6. Evolution of the French version of Ocular Surface Disease Index (OSDI) score over the 6 first months post-operative

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: TEBELID

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 7, 2023
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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