Introduction
vitreous hemorrhage, panretinal, visual impairment, vision impairment
VITREOUS HEMORRHAGE, PROLIFERATIVE DIABETIC RETINOPATHY (PDR), RETINAL NEOVASCULARIZATION, RETINA
Patient-reported outcome measures are often collected in clinical trials to incorporate patient perspective into the study results alongside clinical measures. They can be particularly important in a study showing no difference in important clinical outcomes. In ophthalmic studies, patient-reported outcomes are typically more sensitive to vision changes in the better-seeing eye [DRCR Retina Network Protocol AB was a randomized clinical trial of initial treatment with aflibercept versus vitrectomy with panretinal photocoagulation (PRP) for eyes with vitreous hemorrhage (VH) from proliferative diabetic retinopathy (PDR). Enrolled eyes had substantial visual impairment with a median baseline visual acuity (VA) of 20/200 at baseline. Eyes assigned to aflibercept received 4 mandatory, monthly intravitreal injections through week 16 with additional injections through 2 years if retinal neovascularization was present or VH persisted and with vitrectomy if VH causing vision impairment persisted after 1 month post-surgery. Eyes assigned to vitrectomy with PRP had surgery within 2 weeks, performed in a hospital or outpatient surgical center, typically with use of local anesthesia. Eyes assigned to vitrectomy with VH at 4 weeks or later were treated with 2 mandatory injections of aflibercept with additional injections through 2 years if VH failed to resolve.Mean VA improved substantially in both treatment groups, but the difference in the primary outcome of mean VA over 24 weeks (area under the curve) was not statistically significant (the vitrectomy group had a greater mean improvement by 5.0 letters [95% CI, -0.3 to 10.2]; Given that there was no significant difference in the primary visual acuity outcome between the aflibercept and vitrectomy groups in Protocol AB, patient-reported outcome measures may be useful in assessing other differences in the effects of these treatments. The Work Productivity and Activity Impairment Questionnaire [