Bernard and Shirlee Brown Glaucoma Research Laboratory, Edward S. Harkness Eye Institute, Columbia University Irving Medical Center, 635 West 165th Street, Box 69, New York, NY, 10032, USA.
Ora Clinical, Inc., Andover, MA, USA.
Sci Rep. 2023 May 2;13(1):7098. doi: 10.1038/s41598-023-34009-x.
The purpose of this retrospective, longitudinal study is to evaluate the relationship between MD slope from visual field tests collected over a short period of time (2 years) and the current United States' Food and Drug Administration (FDA) recommended endpoints for visual field outcomes. If this correlation is strong and highly predictive, clinical trials employing MD slopes as primary endpoints could be employed in neuroprotection clinical trials with shorter duration and help expedite the development of novel IOP-independent therapies. Visual field tests of patients with or suspected glaucoma were selected from an academic institution and evaluated based on two functional progression endpoints: (A) five or more locations worsening by at least 7 dB, and (B) at least five test locations based upon the GCP algorithm. A total of 271 (57.6%) and 278 (59.1%) eyes reached Endpoints A and B, respectively during the follow up period. The median (IQR) MD slope of eyes reaching vs. not reaching Endpoint A and B were -1.19 (-2.00 to -0.41) vs. 0.36 (0.00 to 1.00) dB/year and -1.16 (-1.98 to -0.40) vs. 0.41 (0.02 to 1.03) dB/year, respectively (P < 0.001). It was found that eyes experiencing rapid 24-2 visual field MD slopes over a 2-year period were on average tenfold more likely to reach one of the FDA accepted endpoints during or soon after that period.
本回顾性、纵向研究旨在评估在短时间（2 年）内收集的视野测试中 MD 斜率与当前美国食品和药物管理局（FDA）推荐的视野结果终点之间的关系。如果这种相关性很强且具有高度预测性，则可以在持续时间较短的神经保护临床试验中采用 MD 斜率作为主要终点，从而有助于加快新型与眼压无关的治疗方法的开发。从学术机构中选择疑似或确诊青光眼患者的视野测试，并根据两个功能进展终点进行评估：（A）至少 7dB 的 5 个或更多位置恶化，以及（B）根据 GCP 算法至少 5 个测试位置。在随访期间，分别有 271 只（57.6%）和 278 只（59.1%）眼达到终点 A 和 B。达到终点 A 和 B 的眼的 MD 斜率中位数（IQR）分别为-1.19（-2.00 至-0.41）和 0.36（0.00 至 1.00）dB/年，-1.16（-1.98 至-0.40）和 0.41（0.02 至 1.03）dB/年，分别（P < 0.001）。结果发现，在 2 年内经历快速 24-2 视野 MD 斜率的眼在该期间或之后不久达到 FDA 接受的终点之一的可能性平均高出十倍。
