Efficacy and safety of early YAG laser vitreolysis for symptomatic vitreous floaters: the study protocol for a randomized clinical trial

Abstract

Abstract Background Vitreous floaters are a common ocular condition that affects individuals of all ages. Although vitreous floaters are typically benign, they can significantly impair visual acuity and quality of life. Laser vitreolysis, which uses an Nd: YAG laser to vaporize collagenous vitreous opacities, is increasingly being used as a treatment option. However, there is currently a lack of evidence regarding its efficacy and the appropriate timing of its application. The aim of this study is to evaluate the efficacy and safety of early YAG laser vitreolysis in treating symptomatic vitreous floaters. Methods The present study is a randomized, controlled, double-blind clinical trial. A total of 70 participants with symptomatic floaters for one month were recruited. These participants will be randomly assigned to two groups, with 35 individuals in each group: the early treatment group and the delayed treatment group. Participants assigned to the early treatment group will undergo YAG laser vitreolysis immediately, followed by a sham laser treatment three months later. On the other hand, participants assigned to the delayed treatment group will receive a sham laser treatment first, and then undergo YAG laser vitreolysis three months later. The follow-up time points will be 1, 3, 6, and 12 months from randomization. Primary outcomes are participants' self-reported improvement in visual disturbance on a scale of 1 to 10 and their scores on the National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25). Secondary outcomes included an objective evaluation of the effectiveness of the treatment in reducing vitreous floaters through OCT and fundus photography and tracking any adverse events related to the eyes or overall health. Discussion This clinical trial aims to compare the effectiveness of YAG laser vitreolysis in treating symptomatic vitreous floaters and assess the safety of performing early YAG laser vitreolysis. Trial registration clinicaltrials.gov: NCT05800353. Registered March 10, 2023. https://clinicaltrials.gov/study/NCT05800353