61
Participants
Start Date
August 10, 2024
Primary Completion Date
June 11, 2025
Study Completion Date
July 30, 2025
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.
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.
"University of Medicine and Pharmacy Grigore T. Popa Iași,", Iași
Grigore T. Popa University of Medicine and Pharmacy
OTHER