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

NACompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

August 10, 2024

Primary Completion Date

June 11, 2025

Study Completion Date

July 30, 2025

Conditions
Dry EyeMeibomian Gland Dysfunction (Disorder)Ocular Surface Disease
Interventions
DEVICE

Low-Level Light Therapy

The intervention consists of non-invasive periocular photobiomodulation using the Eye-light® device (Espansione Marketing S.p.A., Italy), which delivers low-level monochromatic red light (633 ± 10 nm) through a specially designed mask. Participants receive two 15-minute sessions, one 7 days before and one 7 days after femtosecond laser-assisted in situ keratomileusis (Femto-LASIK). The treatment is designed to stimulate meibomian gland activity, improve tear film stability, and reduce ocular surface inflammation. This protocol is unique compared to standard post-refractive surgery care because it targets cellular mitochondrial activity to enhance tissue repair and anti-inflammatory effects. It is non-pharmacological, non-contact, and well-tolerated, making it suitable for perioperative application. The light is delivered through closed eyelids, ensuring safety and comfort, and the device used is CE-marked for ophthalmic applications.

DEVICE

Sham (No Treatment)

Participants in the Control group underwent the same procedural setup as the LLLT group, using the Eye-light® device (Espansione Marketing S.p.A., Italy). Instead of delivering therapeutic light energy, the device operated in demo mode, emitting less than 30% of the full treatment power. This configuration mimicked the visual and sensory aspects of a low-level light therapy session without producing biologically effective photobiomodulation. Sham treatment consisted of two 15-minute sessions, one 7 days before and one 7 days after Femto-LASIK. This design ensured masking of participants and investigators while preventing active therapeutic exposure in the control group.

Trial Locations (1)

Unknown

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

All Listed Sponsors
lead

Grigore T. Popa University of Medicine and Pharmacy

OTHER

NCT07181668 - Effect of Low-Level Light Therapy on Ocular Surface Parameters in Patients Undergoing Femto-Lasik Surgery | Biotech Hunter | Biotech Hunter