YAG Laser Vitreolysis vs Sham YAG Vitreolysis for Symptomatic Vitreous Floaters: A Randomized Clinical Trial.

Importance: Vitreous floaters are common and can worsen visual quality. YAG vitreolysis is an untested treatment for floaters.

Objective: To evaluate YAG laser vitreolysis vs sham vitreolysis for symptomatic Weiss ring floaters from posterior vitreous detachment.

Design, Setting, and Participants: This single-center, masked, sham-controlled randomized clinical trial was performed from March 25, 2015, to August 3, 2016, in 52 eyes of 52 patients (36 cases and 16 controls) treated at a private ophthalmology practice.

Interventions: Patients were randomly assigned to YAG laser vitreolysis or sham YAG (control).

Main Outcomes and Measures: Primary 6-month outcomes were subjective change measured from 0% to 100% using a 10-point visual disturbance score, a 5-level qualitative scale, and National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25). Secondary outcomes included objective change assessed by masked grading of color fundus photography and Early Treatment Diabetic Retinopathy Study best-corrected visual acuity.

Results: Fifty-two patients (52 eyes; 17 men and 35 women; 51 white and 1 Asian) with symptomatic Weiss rings were enrolled in the study (mean [SD] age, 61.4 [8.0] years for the YAG laser group and 61.1 [6.6] years for the sham group). The YAG laser group reported greater symptomatic improvement (54%) than controls (9%) (difference, 45%; 95% CI, 25%-64%; P < .001). In the YAG laser group, the 10-point visual disturbance score improved by 3.2 vs 0.1 in the sham group (difference, -3.0; 95% CI, -4.3 to -1.7; P < .001). A total of 19 patients (53%) in the YAG laser group reported significantly or completely improved symptoms vs 0 individuals in the sham group (difference, 53%; 95% CI, 36%-69%, P < .001). Compared with sham, NEI VFQ-25 revealed improved general vision (difference, 16.3; 95% CI, 0.9-31.7; P = .04), peripheral vision (difference, 11.6; 95% CI, 0.8-22.4; P = .04), role difficulties (difference, 17.3; 95% CI, 8.0-26.6; P < .001), and dependency (difference, 5.6; 95% CI, 0.5-10.8; P = .03) among the YAG laser group. Best-corrected visual acuity changed by -0.2 letters in the YAG laser group and by -0.6 letters in sham group (difference, 0.4; 95% CI, -6.5 to 5.3; P = .94). No differences in adverse events between groups were identified.

Conclusions and Relevance: YAG laser vitreolysis subjectively improved Weiss ring-related symptoms and objectively improved Weiss ring appearance. Greater confidence in these outcomes may result from larger confirmatory studies of longer duration.

Trial Registration: clinicaltrials.gov NCT02897583.