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年龄相关性黄斑变性的暗适应作为功能结局测量的纵向研究。

Longitudinal Study of Dark Adaptation as a Functional Outcome Measure for Age-Related Macular Degeneration.

机构信息

National Eye Institute, National Institutes of Health, Bethesda, Maryland.

National Eye Institute, National Institutes of Health, Bethesda, Maryland.

出版信息

Ophthalmology. 2019 Jun;126(6):856-865. doi: 10.1016/j.ophtha.2018.09.039. Epub 2018 Sep 29.

Abstract

PURPOSE

To investigate the natural history of dark adaptation (DA) function as measured by the change in rod intercept time (RIT) over 4 years and to correlate RIT change with age-related macular degeneration (AMD) severity.

DESIGN

Longitudinal, single-center, observational study.

PARTICIPANTS

A total of 77 participants aged ≥50 years with a range of AMD severities.

METHODS

Participants each contributing a single study eye to the analysis were assigned into person-based AMD severity groups based on fundus characteristics (drusen, pigmentary changes, late AMD, and subretinal drusenoid deposits [SDDs]). The DA function was assessed in study eyes at baseline and 3, 6, 12, 18, 24, 36, and 48 months. Mean change in DA function over time was calculated using the slope of linear regression fits of longitudinal RIT data. Patient-reported responses on a Low Luminance Questionnaire (LLQ) were obtained at baseline and yearly. Nonparametric statistical testing was performed on all comparisons.

MAIN OUTCOME MEASURE

The RIT, defined as the time taken after a photobleach for visual sensitivity to recover detection of a 5×10 cd/m stimulus (a decrease of 3 log units), was monitored in study eyes over 4 years, and the mean rate of change was computed.

RESULTS

Longitudinal analysis of 65 study eyes followed on the standard testing protocol (mean age, 71±9.3 years; 49% were female) revealed that higher rates of RIT prolongation were correlated with AMD severity group assignment at baseline (P = 0.026) and with severity group assignments at year 4 (P = 0.0011). Study eyes that developed SDD during follow-up demonstrated higher rates of RIT prolongation relative to those that did not (P < 0.0001). Overall, higher rates of RIT prolongation were significantly correlated with greater 4-year decreases in LLQ scores (total mean score, P = 0.0032).

CONCLUSIONS

Longitudinal decline in DA function, which correlated with patient-reported functional deficits, was accelerated in eyes with greater AMD severity and especially in eyes with SDD both at baseline and at 4 years. The RIT prolongation as a measure of changing DA function may be a functional outcome measure in AMD clinical studies.

摘要

目的

研究 4 年内通过视杆细胞截点时间(RIT)变化测量的暗适应(DA)功能的自然史,并将 RIT 变化与年龄相关性黄斑变性(AMD)的严重程度相关联。

设计

纵向、单中心、观察性研究。

参与者

共有 77 名年龄在 50 岁以上的参与者,其 AMD 严重程度不一。

方法

根据眼底特征(玻璃膜疣、色素变化、晚期 AMD 和视网膜下类脂沉积),将每位参与者的单只研究眼分配到基于个体的 AMD 严重程度组。在基线和 3、6、12、18、24、36 和 48 个月时,对研究眼的 DA 功能进行评估。使用纵向 RIT 数据的线性回归拟合的斜率来计算 DA 功能随时间的平均变化。在基线和每年获得患者对低亮度问卷(LLQ)的反应。对所有比较均进行非参数统计检验。

主要观察指标

在 4 年内监测研究眼中的 RIT,定义为光漂白后恢复对 5×10 cd/m 刺激检测的时间(下降 3 个对数单位),并计算平均变化率。

结果

对遵循标准测试方案的 65 只研究眼进行的纵向分析(平均年龄为 71±9.3 岁,49%为女性)表明,RIT 延长的速度与基线时的 AMD 严重程度组分配(P=0.026)和第 4 年的严重程度组分配(P=0.0011)相关。在随访期间发生 SDD 的研究眼与未发生 SDD 的研究眼相比,RIT 延长的速度更高(P<0.0001)。总体而言,RIT 延长的速度与 LLQ 评分在 4 年内的更大下降显著相关(总平均评分,P=0.0032)。

结论

DA 功能的纵向下降与患者报告的功能缺陷相关,在 AMD 严重程度较高的眼中加速,尤其是在基线和 4 年时发生 SDD 的眼中加速。RIT 延长作为 DA 功能变化的测量指标,可能成为 AMD 临床研究中的功能结局指标。

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本文引用的文献

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