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

Regional University Hospital Center (CHRU)

Status: Completed

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

Treatments: Device: IPL+LLLT

Study type: Interventional

Funder types: Other

Identifiers

NCT05803798

29BRC22.0190

Details and patient eligibility

About

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.

Full description

monocentric, randomized, simple bling, controlled study

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups

treatment

Active Comparator group

Description:

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

Treatment:

Device: IPL+LLLT

standard

No Intervention group

Description:

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