Status:
COMPLETED
Effect of Low-Level Light Therapy on Ocular Surface Parameters in Patients Undergoing Femto-Lasik Surgery
Lead Sponsor:
Grigore T. Popa University of Medicine and Pharmacy
Conditions:
Dry Eye
Meibomian Gland Dysfunction (Disorder)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 o...
Detailed Description
This multicenter, randomized, double-masked, sham-controlled clinical trial was conducted to evaluate the efficacy and safety of perioperative low-level light therapy (LLLT) in preventing dry eye dise...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2025
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT07181668
Start Date
August 10 2024
End Date
July 30 2025
Last Update
September 25 2025
Active Locations (1)
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1
University of Medicine and Pharmacy "Grigore T. Popa" Iași,
Iași, Romania