Solomon Sharon D, Kyerematen Victoria, Qutab Madiha, Wenick Adam S, Wang Jiangxia, Hawkins Barbara S
Department of Ophthalmology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Bloomfield Court Hospital, National Health Services, London, UK.
Clin Ophthalmol. 2021 Aug 12;15:3401-3417. doi: 10.2147/OPTH.S315554. eCollection 2021.
To report findings when dilated fundus examination (DFE) is omitted from follow-up of patients receiving anti-VEGF injections for neovascular age-related macular degeneration (NVAMD).
Randomized pilot study.
NVAMD patients with two or more injections of anti-VEGF within prior six months who were expected to require treatment for at least eight more months.
Participants were assigned to either retinal imaging and DFE or retinal imaging without a DFE except at 16 weeks and 32 weeks and at study completion.
Primary safety outcomes were change in usual-corrected visual acuity (UCVA) and central subfield thickness (CST). Primary efficacy outcomes included time spent in clinic and patient satisfaction with clinic visits.
The 66 participants had mean baseline UCVA of 20/50 in the study eye. Median change in UCVA from baseline to each clinic visit in each arm was "no change". Mean change in CST was less than 15 microns from baseline to any follow-up clinic visit. Time spent in the clinic at follow-up visits averaged 20 minutes less for participants in the Imaging Only group than those in the Full Exam group. More participants in the Imaging Only group were satisfied with the time spent in clinic and with the clinic visits overall than participants in the Full Exam group: means of 71 vs 91 minutes, respectively, per clinic visit.
Based on findings from this randomized pilot study, follow-up retina clinic visits for established patients who have NVAMD and are under treatment with intravitreous injection of anti-VEGF agents could be streamlined by implementing longer intervals between DFE and by relying on imaging alone to make most decisions regarding the need for retreatment, thereby reducing the time spent by patients in clinic and increasing their satisfaction with care received, without excess adverse events.
NCT02251366.
报告在接受抗血管内皮生长因子（VEGF）注射治疗新生血管性年龄相关性黄斑变性（NVAMD）的患者随访中省略散瞳眼底检查（DFE）时的研究结果。
随机试点研究。
在过去六个月内接受过两次或更多次抗VEGF注射且预计至少还需治疗八个月的NVAMD患者。
参与者被随机分为两组，一组接受视网膜成像和DFE，另一组除在第16周、32周及研究结束时外不进行DFE，仅接受视网膜成像。
主要安全性指标为常规矫正视力（UCVA）和中心子野厚度（CST）的变化。主要疗效指标包括在诊所花费的时间以及患者对就诊的满意度。
66名参与者研究眼的平均基线UCVA为20/50。每组从基线到每次诊所就诊时UCVA的中位数变化为“无变化”。从基线到任何一次随访诊所就诊时，CST的平均变化小于15微米。仅成像组参与者随访就诊时在诊所花费的时间平均比全面检查组少20分钟。仅成像组中对在诊所花费的时间以及总体就诊情况满意的参与者比全面检查组更多：每次诊所就诊的平均时间分别为71分钟和91分钟。
基于这项随机试点研究的结果，对于已确诊的NVAMD且正在接受玻璃体内注射抗VEGF药物治疗的患者，通过延长DFE之间的间隔时间并仅依靠成像来做出大多数关于再次治疗需求的决策，可以简化视网膜诊所的随访流程，从而减少患者在诊所花费的时间并提高他们对所接受治疗的满意度，且不会增加不良事件。
NCT02251366
