CompletedNot Applicable

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

Romania98 participantsStarted 2025-01-08

Plain-language summary

This randomized, controlled clinical trial investigates the perioperative use of low-level light therapy (LLLT) to prevent or reduce signs and symptoms of dry eye disease (DED) in patients undergoing cataract surgery. DED is a prevalent postoperative complication associated with ocular surface inflammation, meibomian gland dysfunction, and tear film instability, which can compromise visual outcomes and patient satisfaction. The study enrolled adult patients scheduled for phacoemulsification, with baseline evidence of mild-to-moderate ocular surface disease. Participants were randomly assigned to receive either LLLT via a polychromatic light-emitting mask (Eye-light® ) or a sham device, administered one week before and one week after surgery. The LLLT protocol is designed to photobiomodulate eyelid and periocular tissues to enhance meibomian gland function and reduce subclinical inflammation. Clinical assessments were conducted at baseline, one week, and six months postoperatively. The primary endpoint was the change in Ocular Surface Disease Index (OSDI) score at one and six months. Secondary endpoints included tear film stability (TBUT), Schirmer I test, corneal staining, tear osmolarity, and tear inflammatory and reparative biomarkers. The study also evaluated the safety and tolerability of the LLLT intervention. This is the first prospective study assessing the role of perioperative LLLT in mitigating post-cataract ocular surface disease in consecutive patients. The findings may support the integration of LLLT in perioperative ocular surface management protocols.

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: * Consecutive adult patients (aged ≥18 years). * Scheduled for routine phacoemulsification cataract surgery. * Provided written informed consent and agreed to attend all follow-up visits. 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 (e.g., glaucoma, uveitis, corneal dystrophies). * Current or regular use of topical ocular treatments such as lubricants, corticosteroids, or cyclosporine. * Ongoing or recent instrumental therapies or oral supplements for OSD or DED. * Use of systemic medications known to be associated with DED (e.g., diuretics, antidepressants, antihistamines, hormone replacement therapy). * History of autoimmune diseases (e.g., Sjögren's syndrome). * Regular contact lens wear. * Any intraoperative or postoperative complications that could interfere with ocular surface evaluation.

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 Disease Index (OSDI)

Timeframe: Baseline to 6 months after cataract surgery

Trial details

NCT IDNCT07067294

SponsorGrigore T. Popa University of Medicine and Pharmacy

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-11

View on ClinicalTrials.gov More Dry Eye trials