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CATT 研究中的年龄相关性黄斑变性治疗试验中偶发性视力丧失。

Sporadic visual acuity loss in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT).

机构信息

Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.

Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.

出版信息

Am J Ophthalmol. 2014 Jul;158(1):128-135.e10. doi: 10.1016/j.ajo.2014.04.004. Epub 2014 Apr 13.

Abstract

PURPOSE

To evaluate transient, large visual acuity (VA) decreases, termed sporadic vision loss, during anti-vascular endothelial growth factor treatment for neovascular age-related macular degeneration (AMD).

DESIGN

Cohort within a randomized clinical trial.

METHODS

setting: Comparison of Age-Related Macular Degeneration Treatments Trials (CATT). study population: Total of 1185 CATT patients. main outcome measures: Incidence of sporadic vision loss and odds ratio (OR) for association with patient and ocular factors. Sporadic vision loss was a decline of ≥15 letters from the previous visit, followed by a return at the next visit to no more than 5 letters worse than the visit before the VA loss.

RESULTS

There were 143 sporadic vision loss events in 122 of 1185 patients (10.3%). Mean VA at 2 years for those with and without sporadic vision loss was 58.5 (∼20/63) and 68.4 (∼20/40) letters, respectively (P < .001). Among patients treated pro re nata, no injection was given for 27.6% (27/98) of sporadic vision loss events. Multivariate analysis demonstrated that baseline predictors for sporadic vision loss included worse baseline VA (OR 2.92, 95% confidence interval [CI]:1.65-5.17 for ≤20/200 compared with ≥20/40), scar (OR 2.21, 95% CI:1.22-4.01), intraretinal foveal fluid on optical coherence tomography (OR 1.80, 95% CI:1.11-2.91), and medical history of anxiety (OR 1.90, 95% CI:1.12-3.24) and syncope (OR 2.75, 95% CI:1.45-5.22). Refraction decreased the likelihood of sporadic vision loss (OR 0.62, 95%CI: 0.42-0.91).

CONCLUSIONS

Approximately 10% of CATT patients had sporadic vision loss. Baseline predictors included AMD-related factors and factors independent of AMD. These data are relevant for clinicians in practice and those involved in clinical trials.

摘要

目的

评估接受抗血管内皮生长因子治疗新生血管性年龄相关性黄斑变性(AMD)时发生的一过性、大视力(VA)下降,称为偶发性视力丧失。

设计

在一项随机临床试验内的队列研究。

方法

研究地点:年龄相关性黄斑变性治疗试验(CATT)的比较。研究人群:共有 1185 名 CATT 患者。主要观察指标:偶发性视力丧失的发生率和与患者及眼部因素相关的比值比(OR)。偶发性视力丧失是指与前一次就诊相比,视力下降≥15 个字母,随后在下一次就诊时恢复,视力不超过比视力丧失前差 5 个字母。

结果

在 1185 名患者中的 122 名(10.3%)发生了 143 次偶发性视力丧失事件。有偶发性视力丧失和无偶发性视力丧失患者的平均 VA 在 2 年时分别为 58.5(约 20/63)和 68.4(约 20/40)个字母,差异有统计学意义(P<0.001)。在接受按需治疗的患者中,27.6%(27/98)的偶发性视力丧失事件未进行注射。多变量分析显示,偶发性视力丧失的基线预测因素包括基线 VA 更差(OR 2.92,95%置信区间[CI]:1.65-5.17,与≥20/40 相比,≤20/200)、瘢痕(OR 2.21,95% CI:1.22-4.01)、光学相干断层扫描(OCT)上的视网膜内中心凹下液(OR 1.80,95% CI:1.11-2.91)、焦虑病史(OR 1.90,95% CI:1.12-3.24)和晕厥(OR 2.75,95% CI:1.45-5.22)。屈光度降低偶发性视力丧失的可能性(OR 0.62,95%CI:0.42-0.91)。

结论

大约 10%的 CATT 患者出现偶发性视力丧失。基线预测因素包括 AMD 相关因素和与 AMD 无关的因素。这些数据对临床医生和临床试验参与者都具有重要意义。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/19a9/4301065/1714bf306be0/nihms597209f1.jpg

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