Department of Ophthalmology, Albert-Ludwigs-University, Freiburg im Breisgau, Germany.
Department of Ophthalmology, Faculty of Medicine, Christian-Albrechts-University, Kiel, Germany.
Retina. 2018 Jun;38(6):1134-1144. doi: 10.1097/IAE.0000000000001681.
The PONS study was conceived to analyze the extent of nonpersistence (NP) and nonadherence (NA) in the treatment of patients with neovascular age-related macular degeneration in everyday clinical practice in Germany. Further objectives were to identify factors that can affect NP and NA and to analyze clinical outcomes under everyday conditions.
Nonpersistence (no contact with doctor for at least 3 months) and NA (no treatment or follow-up for at least 6 weeks) as well as clinical data were analyzed up to 24 months retrospectively and 12 months prospectively in 480 patients with neovascular age-related macular degeneration in 23 treatment centers. Patients were interviewed for factors possibly affecting NP and NA.
One third of patients fulfilled criteria of NA in the first 3 months and two thirds after 6 months. The NP was 18.8% after 12 months. Treatment exclusively at one center, a higher number of patients with neovascular age-related macular degeneration at the treating center, and fixed appointments were associated with a lower risk for NP. An initial gain in visual acuity after upload was not preserved after 12 months (mean change -0.5 Early Treatment Diabetic Retinopathy Study letters). Whereas visual acuity declined by 7.5 Early Treatment Diabetic Retinopathy Study letters in patients with good baseline visual acuity >20/40, visual acuity improved by 8.5 letters in patients with baseline visual acuity of ≤20/200. Only 7.5% of patients underwent an optical coherence tomography scan after 3 upload injections, and only 2.0 optical coherence tomographies were performed in the first 12 months.
The NP and NA were high in our study population and are likely to have contributed to a suboptimal clinical outcome compared with randomized clinical trials. Shortcomings in the management of patients with neovascular age-related macular degeneration, including restrictions in the timely and adequate follow-up (including optical coherence tomography) and retreatment, appear to be constraining factors in Germany.
PONS 研究旨在分析德国临床实践中治疗新生血管性年龄相关性黄斑变性患者时持续性（NP）和不依从性（NA）的程度。进一步的目标是确定可能影响 NP 和 NA 的因素，并分析日常情况下的临床结果。
回顾性分析了 23 个治疗中心的 480 名新生血管性年龄相关性黄斑变性患者的 24 个月内和前瞻性分析了 12 个月内的 NP（至少 3 个月未与医生联系）和 NA（至少 6 周未治疗或随访）以及临床数据。对可能影响 NP 和 NA 的因素对患者进行了访谈。
三分之一的患者在最初的 3 个月内符合 NA 的标准，三分之二的患者在 6 个月后符合标准。NP 在 12 个月时为 18.8%。仅在一个中心治疗、治疗中心有更多的新生血管性年龄相关性黄斑变性患者以及固定预约与 NP 风险降低相关。上传后初始视力提高在 12 个月后无法保持（平均变化-0.5 早期治疗糖尿病视网膜病变研究字母）。在基线视力较好（>20/40）的患者中，视力下降了 7.5 个早期治疗糖尿病视网膜病变研究字母，而在基线视力较差（≤20/200）的患者中，视力提高了 8.5 个字母。仅 7.5%的患者在 3 次上传后进行了光学相干断层扫描，在前 12 个月内仅进行了 2.0 次光学相干断层扫描。
在我们的研究人群中，NP 和 NA 发生率较高，与随机临床试验相比，这可能导致临床结局不佳。新生血管性年龄相关性黄斑变性患者管理方面的不足，包括及时和充分的随访（包括光学相干断层扫描）和再治疗的限制，似乎是德国的制约因素。
