LLLT-LasikLow-Level Light Therapy for Dry Eye Prevention in Femto-LASIK Patients
Low-Level Light Therapy
+ Sham (No Treatment)
Meibomian Gland Dysfunction+2
+ Eye Diseases
+ Eyelid Diseases
Treatment Study
Summary
Study start date: August 10, 2024
Actual date on which the first participant was enrolled.This study focuses on exploring a new way to prevent dry eye symptoms in patients undergoing a common eye surgery called Femto-LASIK. Dry eye disease is a frequent problem after this type of surgery, often due to changes in the eye's tear production system. This can lead to discomfort and slower recovery of vision. The study investigates the use of a treatment called low-level light therapy (LLLT), which uses gentle red light to potentially improve eye health and prevent dry eye symptoms. The trial aims to see if LLLT can help maintain better tear levels and improve comfort for patients after surgery. Participants in the study are adults scheduled for Femto-LASIK, and those with existing eye conditions or who have had other surgeries are not included. They are randomly assigned to receive either the real LLLT treatment or a sham treatment with much less power, to ensure fair comparison. The LLLT treatment is applied around the eyes for 15 minutes before and after the surgery, using a special device. Researchers assess the results by checking the patients' tear levels and eye comfort at several points after the surgery. They look for improvements in tear production and stability, as well as any side effects. The study found that the LLLT group maintained better eye moisture levels compared to the sham group, with no adverse effects reported, suggesting LLLT could be a promising option to enhance recovery after LASIK surgery.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.61 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ShamStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Medicine and Pharmacy "Grigore T. Popa" Iași,
Iași, RomaniaOpen University of Medicine and Pharmacy "Grigore T. Popa" Iași, in Google Maps