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

NACompletedINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

January 8, 2025

Primary Completion Date

March 31, 2025

Study Completion Date

April 14, 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 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."

DEVICE

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."

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

NCT07067294 - Effect of Low-Level Light Therapy on Ocular Surface Parameters in Patients Undergoing Cataract Surgery | Biotech Hunter | Biotech Hunter