Combined Treatment With Pulsed Light and Photobiomodulation Before Laser Refractive Surgery

NCT ID: NCT05803798

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-06

Study Completion Date

2025-04-16

Brief Summary

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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

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monocentric, randomized, simple bling, controlled study

Conditions

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Dry Eye Dry Eye After LASIK-Laser in Situ Keratomileusis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Treatment group = LLLT+IPL (EYE-LIGHT) before laser refractive surgery
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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treatment

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

Group Type ACTIVE_COMPARATOR

IPL+LLLT

Intervention Type DEVICE

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

standard

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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IPL+LLLT

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

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Béatrice COCHENER-LAMARD, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitary Hospital of Brest

Locations

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CHU Brest

Brest, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 32629039 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19376264 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28736340 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28736342 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32182637 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26733111 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28736337 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28736341 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25458707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31106754 (View on PubMed)

Other Identifiers

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29BRC22.0190

Identifier Type: -

Identifier Source: org_study_id

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