CompletedNot Applicable

Effect of Low-Level Light Therapy on Ocular Surface Parameters in Patients Undergoing Femto-Lasik Surgery

Romania61 participantsStarted 2024-08-10

Plain-language summary

This study evaluates the role of perioperative low-level light therapy (LLLT) in reducing dry eye disease (DED) symptoms after femtosecond laser-assisted in situ keratomileusis (Femto-LASIK). DED is one of the most frequent complications following Femto-LASIK, potentially affecting both visual recovery and patient satisfaction. In this prospective, multicenter, randomized, double-masked, sham-controlled trial, adult patients undergoing Femto-LASIK were assigned to receive either periocular LLLT (Eye-light® )or sham treatment before and after surgery. Tear film parameters and ocular surface symptoms were assessed at baseline, 1 week, 1 month, and 3 months postoperatively. Results showed that patients treated with LLLT maintained stable tear volume and reported fewer ocular discomfort symptoms compared with controls, who experienced significant declines. No adverse events related to LLLT were observed. These findings suggest that perioperative LLLT is a safe and well-tolerated approach that may help preserve tear film stability and improve postoperative comfort in Femto-LASIK patients.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged ≥18 years. * Scheduled for bilateral Femto-LASIK surgery for refractive error correction. * Willing and able to provide written informed consent. * Ability and willingness to comply with all study procedures and follow-up visits. * Baseline ocular surface within normal limits (no pre-existing dry eye or ocular surface disease) Exclusion Criteria: * Prior diagnosis of ocular surface disease (OSD) or dry eye disease (DED). * History of ocular surgery in either eye. * Presence of ocular comorbidities such as glaucoma, corneal dystrophies, or active ocular infections. * Current or regular use of topical ocular treatments, including lubricants, corticosteroids, cyclosporine, or other drugs for DED or OSD. * Use of instrumental therapies for ocular surface or tear film optimization (e.g., thermal pulsation, IPL). * Systemic treatments known to influence tear production (e.g., diuretics, antihistamines, antidepressants, hormone replacement therapy). * Autoimmune diseases affecting the eyes, including Sjögren's syndrome or rheumatoid arthritis. * Any intraoperative or postoperative complications that could interfere with ocular surface assessment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ocular Surface Preservation after Femto-LASIK with LLLT

Timeframe: Baseline (1 week preoperatively, T0) to 3 months postoperatively (T3)

Trial details

NCT IDNCT07181668

SponsorGrigore T. Popa University of Medicine and Pharmacy

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-11

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