Hsu S Tammy, Thompson Atalie C, Stinnett Sandra S, Luhmann Ulrich F O, Vajzovic Lejla, Horne Anupama, Schuman Stefanie G, Toth Cynthia A, Cousins Scott W, Lad Eleonora M
Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina.
Roche Pharmaceutical Research and Early Development, Translational Medicine Neuroscience & Ophthalmology & Rare Diseases Biomarkers, Roche Innovation Center Basel, Basel, Switzerland.
Ophthalmol Retina. 2019 Aug;3(8):637-648. doi: 10.1016/j.oret.2019.03.010. Epub 2019 Mar 21.
To report the 1-year progression of visual impairment on psychophysical tests of visual function in patients with early and intermediate age-related macular degeneration (AMD).
Prospective, observational study.
Patients with early and intermediate AMD were enrolled from the existing population at the Duke Eye Center, and healthy age-matched control participants were recruited from family members or friends of the AMD patients and from the Duke Optometry and Comprehensive Eye Clinics.
Patients and control participants recruited during the baseline study were assessed at both 6 and 12 months after the initial study visit. Measurements of visual function included best-corrected visual acuity (BCVA), low-luminance visual acuity (LLVA), low-luminance deficit (LLD), microperimetry percent-reduced threshold (PRT), microperimetry average threshold (AT), and cone contrast tests (CCTs).
Changes in BCVA, LLVA, LLD, microperimetry PRT, microperimetry AT, and CCT results from baseline to 6 months and to 12 months were assessed.
Eighty-five patients completed the 12-month examination (19 control participants, 27 early AMD patients, and 39 intermediate AMD patients). Longitudinal analysis detected significant changes from baseline within each group in microperimetry PRT and AT and in the intermediate AMD group only for BCVA and CCT results (P < 0.05).
Microperimetry and CCT are able to detect functional changes resulting from progression of dry AMD within a period as short as 12 months. These functional markers may be useful end points in future clinical trials that assess the effect of potential treatments for AMD.
报告早期和中期年龄相关性黄斑变性(AMD)患者视觉功能心理物理学测试中视力损害的1年进展情况。
前瞻性观察性研究。
从杜克眼科中心的现有人口中招募早期和中期AMD患者,从AMD患者的家庭成员或朋友以及杜克验光和综合眼科诊所招募年龄匹配的健康对照参与者。
在基线研究期间招募的患者和对照参与者在初次研究访视后的6个月和12个月时均进行评估。视觉功能测量包括最佳矫正视力(BCVA)、低亮度视力(LLVA)、低亮度缺陷(LLD)、微视野检查降低阈值百分比(PRT)、微视野检查平均阈值(AT)和视锥细胞对比测试(CCT)。
评估从基线到6个月以及到12个月时BCVA、LLVA、LLD、微视野检查PRT、微视野检查AT和CCT结果的变化。
85名患者完成了12个月的检查(19名对照参与者、27名早期AMD患者和39名中期AMD患者)。纵向分析发现,每组中微视野检查PRT和AT以及仅在中期AMD组中BCVA和CCT结果与基线相比有显著变化(P<0.05)。
微视野检查和CCT能够在短短12个月内检测到干性AMD进展导致的功能变化。这些功能标志物可能是未来评估AMD潜在治疗效果的临床试验中有价值的终点指标。