Combined Treatment With Pulsed Light and Photobiomodulation Before Laser Refractive Surgery

NCT05803798 | Completed DMC

• 1 other identifier: 29BRC22.0190
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye; Dry Eye After LASIK-Laser in Situ Keratomileusis

Keywords

dry eye; laser refractive surgery; smile; lasik; presbylasik; photorefractive keratectomy; intense-pulsed light; low-level-light therapy; photobiomodulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  6 months post-operative

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

  6 months post-operative

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

  6 months post-operative

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

  6 months post-operative

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

  6 months post-operative

Study Arms (2)

treatment

ACTIVE COMPARATOR

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

Device: IPL+LLLT

standard

NO INTERVENTION

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

Interventions

IPL+LLLT DEVICE

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

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHU Brest

Brest, France

Location

Related Publications (11)

• 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.

  PMID: 19376264 BACKGROUND

• 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.

  PMID: 28736340 BACKGROUND

• 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.

  PMID: 28736342 BACKGROUND

• 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.

  PMID: 32629039 BACKGROUND

• 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.

  PMID: 32182637 BACKGROUND

• 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.

  PMID: 26733111 BACKGROUND

• 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.

  PMID: 28736337 BACKGROUND

• 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.

  PMID: 28736341 BACKGROUND

• 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.

  PMID: 25458707 BACKGROUND

• 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.

  PMID: 31106754 BACKGROUND

• Kerkouri S, Garcin T, Cochener B. Study protocol for a randomised controlled trial to evaluate the prophylactic efficacy of combined intense pulsed light (IPL) and low-level light therapy (LLLT) in preventing laser corneal refractive surgery-induced dry eye: the Treat Eye Before Laser induced Dry (TEBeLiD) study. BMJ Open. 2026 Feb 26;16(2):e095089. doi: 10.1136/bmjopen-2024-095089.

  PMID: 41748188 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes; Smiling

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Facial Expression; Nonverbal Communication; Communication; Behavior

Study Officials

• Béatrice COCHENER-LAMARD, MD, PhD

  Universitary Hospital of Brest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment group = LLLT+IPL (EYE-LIGHT) before laser refractive surgery

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 7, 2023
• Study Start: June 6, 2023
• Primary Completion: November 27, 2024
• Study Completion: April 16, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available beginning five years and ending fifteen years following the final study report completion
• 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.

Locations

FR (1)