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

ABSTRACT:

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.

SUBMITTER: Shah CP 

PROVIDER: S-EPMC5710539 | biostudies-literature |

REPOSITORIES: biostudies-literature