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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Dry Eye After LASIK-Laser in Situ Keratomileusis
• Intervention / Treatment: Device: IPL+LLLT

Detailed Description

monocentric, randomized, simple bling, controlled study

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France
    • CHU Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	6 months post-operative
Evolution of visual acuity over the 6 first 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 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.	6 months post-operative

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Béatrice COCHENER-LAMARD, MD, PhD, Universitary Hospital of Brest

Publications and helpful links

General Publications

• Wolffsohn JS, Arita R, Chalmers R, Djalilian A, Dogru M, Dumbleton K, Gupta PK, Karpecki P, Lazreg S, Pult H, Sullivan BD, Tomlinson A, Tong L, Villani E, Yoon KC, Jones L, Craig JP. TFOS DEWS II Diagnostic Methodology report. Ocul Surf. 2017 Jul;15(3):539-574. doi: 10.1016/j.jtos.2017.05.001. Epub 2017 Jul 20.
• Stapleton F, Alves M, Bunya VY, Jalbert I, Lekhanont K, Malet F, Na KS, Schaumberg D, Uchino M, Vehof J, Viso E, Vitale S, Jones L. TFOS DEWS II Epidemiology Report. Ocul Surf. 2017 Jul;15(3):334-365. doi: 10.1016/j.jtos.2017.05.003. Epub 2017 Jul 20.
• Tashbayev B, Yazdani M, Arita R, Fineide F, Utheim TP. Intense pulsed light treatment in meibomian gland dysfunction: A concise review. Ocul Surf. 2020 Oct;18(4):583-594. doi: 10.1016/j.jtos.2020.06.002. Epub 2020 Jul 3.
• Gomes JAP, Azar DT, Baudouin C, Efron N, Hirayama M, Horwath-Winter J, Kim T, Mehta JS, Messmer EM, Pepose JS, Sangwan VS, Weiner AL, Wilson SE, Wolffsohn JS. TFOS DEWS II iatrogenic report. Ocul Surf. 2017 Jul;15(3):511-538. doi: 10.1016/j.jtos.2017.05.004. Epub 2017 Jul 20.
• Denoyer A, Landman E, Trinh L, Faure JF, Auclin F, Baudouin C. Dry eye disease after refractive surgery: comparative outcomes of small incision lenticule extraction versus LASIK. Ophthalmology. 2015 Apr;122(4):669-76. doi: 10.1016/j.ophtha.2014.10.004. Epub 2014 Nov 22.
• Kim TI, Alio Del Barrio JL, Wilkins M, Cochener B, Ang M. Refractive surgery. Lancet. 2019 May 18;393(10185):2085-2098. doi: 10.1016/S0140-6736(18)33209-4.
• Bron AJ, de Paiva CS, Chauhan SK, Bonini S, Gabison EE, Jain S, Knop E, Markoulli M, Ogawa Y, Perez V, Uchino Y, Yokoi N, Zoukhri D, Sullivan DA. TFOS DEWS II pathophysiology report. Ocul Surf. 2017 Jul;15(3):438-510. doi: 10.1016/j.jtos.2017.05.011. Epub 2017 Jul 20.
• Dartt DA. Neural regulation of lacrimal gland secretory processes: relevance in dry eye diseases. Prog Retin Eye Res. 2009 May;28(3):155-77. doi: 10.1016/j.preteyeres.2009.04.003. Epub 2009 Apr 17.
• Cote S, Zhang AC, Ahmadzai V, Maleken A, Li C, Oppedisano J, Nair K, Busija L, Downie LE. Intense pulsed light (IPL) therapy for the treatment of meibomian gland dysfunction. Cochrane Database Syst Rev. 2020 Mar 18;3(3):CD013559. doi: 10.1002/14651858.CD013559.
• McDonald M, Patel DA, Keith MS, Snedecor SJ. Economic and Humanistic Burden of Dry Eye Disease in Europe, North America, and Asia: A Systematic Literature Review. Ocul Surf. 2016 Apr;14(2):144-67. doi: 10.1016/j.jtos.2015.11.002. Epub 2015 Dec 28.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Actual): November 27, 2024
• Study Completion (Actual): April 16, 2025

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: dry eye; photobiomodulation; laser refractive surgery; photorefractive keratectomy; lasik; smile; presbylasik; intense-pulsed light; low-level-light therapy
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Behavior; Communication; Facial Expression; Nonverbal Communication; Dry Eye Syndromes; Smiling
• Other Study ID Numbers: 29BRC22.0190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified (coded/pseudonymised) individual participant data from the TEBeLiD randomized trial that underlie the primary and secondary publications/final study report. Dataset includes baseline demographics/clinical characteristics, randomization group, procedural variables, follow-up outcomes (e.g., F-OSDI/OSDI, tear film break-up time, corneal staining/Oxford score, Schirmer test, meibomian gland assessment/meibography), adverse events, and protocol deviations. A data dictionary and variable coding will be provided.
• IPD Sharing Time Frame: Data will be available beginning five years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest University Hospital (CHU de Brest). Requests must include a research proposal and analysis plan (and ethics approval/exemption if applicable). Approved requestors will be required to sign and comply with a data access/data use agreement (no re-identification; secure storage; no onward sharing; acknowledgement/citation of TEBeLiD investigators). Data will be provided via secure transfer or controlled-access environment.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No