Completed

LLLT-LasikLow-Level Light Therapy for Dry Eye Prevention in Femto-LASIK Patients

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What is being tested

Low-Level Light Therapy

+ Sham (No Treatment)

Device
Who is being recruted

Meibomian Gland Dysfunction+2

+ Eye Diseases

+ Eyelid Diseases

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: August 2024
See protocol details

Summary

Principal SponsorGrigore T. Popa University of Medicine and Pharmacy
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 10, 2024

Actual date on which the first participant was enrolled.

This study focuses on exploring a new way to prevent dry eye symptoms in patients undergoing a common eye surgery called Femto-LASIK. Dry eye disease is a frequent problem after this type of surgery, often due to changes in the eye's tear production system. This can lead to discomfort and slower recovery of vision. The study investigates the use of a treatment called low-level light therapy (LLLT), which uses gentle red light to potentially improve eye health and prevent dry eye symptoms. The trial aims to see if LLLT can help maintain better tear levels and improve comfort for patients after surgery. Participants in the study are adults scheduled for Femto-LASIK, and those with existing eye conditions or who have had other surgeries are not included. They are randomly assigned to receive either the real LLLT treatment or a sham treatment with much less power, to ensure fair comparison. The LLLT treatment is applied around the eyes for 15 minutes before and after the surgery, using a special device. Researchers assess the results by checking the patients' tear levels and eye comfort at several points after the surgery. They look for improvements in tear production and stability, as well as any side effects. The study found that the LLLT group maintained better eye moisture levels compared to the sham group, with no adverse effects reported, suggesting LLLT could be a promising option to enhance recovery after LASIK surgery.

Official TitlePerioperative Low-Level Light Therapy for Ocular Surface Protection in Patients Undergoing Femto-LASIK: A Prospective Double-masked, Randomized Controlled Study
NCT07181668
Principal SponsorGrigore T. Popa University of Medicine and Pharmacy
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

61 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Meibomian Gland DysfunctionEye DiseasesEyelid DiseasesLacrimal Apparatus DiseasesDry Eye Syndromes

Criteria

5 inclusion criteria required to participate
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.

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8 exclusion criteria prevent from participating
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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants in the LLLT group received periocular low-level light therapy (LLLT) using the Eye-light® device (Espansione Marketing S.p.A., Italy) for 15 minutes per session, one week before and one week after femtosecond laser-assisted in situ keratomileusis (Femto-LASIK). The device delivers red light at 633 ± 10 nm through closed eyelids, targeting the periocular region and meibomian glands to support tear film stability and reduce ocular discomfort. All participants underwent standard Femto-LASIK surgery and received identical postoperative care, including topical antibiotics, corticosteroids, and preservative-free artificial tears. Of the 31 patients initially assigned to the LLLT group, 6 were lost to follow-up, leaving 23 patients (46 eyes) for the final analysis.

Group II

Sham
Participants in the Control group underwent a sham treatment using the same Eye-light® device with minimal energy (\<30% of the full therapeutic dose) for 15 minutes per session, also one week before and one week after surgery. This procedure mimicked LLLT without providing therapeutic light exposure. Postoperative care and clinical assessments were identical to the LLLT group. Of the 30 patients initially assigned to the Control group, 13 were lost at the follow up leaving 17 patients (34 eyes) for the final analysis.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Medicine and Pharmacy "Grigore T. Popa" Iași,

Iași, RomaniaOpen University of Medicine and Pharmacy "Grigore T. Popa" Iași, in Google Maps
CompletedOne Study Center