98
Participants
Start Date
January 8, 2025
Primary Completion Date
March 31, 2025
Study Completion Date
April 14, 2025
Low-Level Light Therapy
"The intervention consists of non-invasive periocular photobiomodulation using the Eye-light® device (Espansione Group, Italy), which delivers low-level polychromatic red and near-infrared light (600-1200 nm) through a specially designed mask. Participants receive two 15-minute sessions, one 7 days before and one 7 days after cataract surgery.~The treatment is designed to stimulate meibomian gland activity, improve tear film stability, reduce ocular surface inflammation.~This protocol is unique compared to standard treatments for dry eye 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)
"Sham-treated controls underwent the same procedural setup as the active treatment group, using the Eye-light® device (Espansione Group, Italy). However, instead of delivering therapeutic levels of light energy, the device operated in demo light mode, emitting less than 30% of the full treatment power. This setting simulated the visual and sensory experience of a low-level light therapy (LLLT) session without delivering biologically effective photobiomodulation.~The sham intervention included two 15-minute sessions: one administered 7 days before cataract surgery and one 7 days after. This approach allowed for masking of participants and investigators to minimize bias, while ensuring that patients in the control group received no active therapeutic exposure."
"University of Medicine and Pharmacy Grigore T. Popa Iași", Iași
Grigore T. Popa University of Medicine and Pharmacy
OTHER