Hamilton Glaucoma Center and Department of Ophthalmology, University of California, San Diego, La Jolla, California, USA.
Ophthalmology. 2011 Oct;118(10):1995-2000. doi: 10.1016/j.ophtha.2011.03.015. Epub 2011 Jun 15.
A core assumption for the 1-eye therapeutic trial of ocular hypotensive medications is the symmetrical reduction of intraocular pressure (IOP) in paired eyes. This assumption was evaluated for 24-hour IOP reduction in patients who underwent monotherapy or adjunctive therapy.
Database study.
Patients 41 to 79 years of age with primary open-angle glaucoma or ocular hypertension.
Twenty-four-hour IOP data from the paired eyes of patients undergoing bilateral monotherapy (n = 66) of latanoprost, travoprost, timolol, or brimonidine or bilateral adjunctive therapy (n = 52) with brinzolamide or timolol added to latanoprost monotherapy were analyzed retrospectively. Measurements of IOP were obtained every 2 hours in a sleep laboratory before and after at least 4-week drug treatments. Strengths of association for single-pair IOP reductions and average IOP reductions in the paired eyes during the office-hour, diurnal, nocturnal, and 24-hour periods and in different body positions were analyzed.
Variance for the difference, percentage distribution of large absolute difference, and coefficient of determination (r(2)) in the paired IOP reductions.
The standard deviations for the differences in single-pair IOP reductions from the means were larger than 2.5 mmHg for all periods and body positions under monotherapy and adjunctive therapy. Absolute differences in single-pair IOP reductions of the cutoff thresholds of 3 and 2 mmHg or more occurred in more than 20% and 36% cases, respectively. Corresponding coefficients of determination were 0.240 to 0.374 with monotherapy and 0.215 to 0.381 with adjunctive therapy. When the average differences in the paired IOP reductions were analyzed for a specific period and posture, the standard deviations for the differences in the paired IOP reductions and the percentage distributions of large absolute differences were reduced, and most coefficients of determination were improved.
There is only a weak association between the right- and left-eye responses to IOP-lowering monotherapy or adjunctive therapy during a 24-hour period when single-pair IOP data are considered. Considering the averages of multiple paired IOP responses can improve the strength of the association.
FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.
对于降低眼内压的药物的单眼治疗试验,一个核心假设是双眼的眼压(IOP)呈对称下降。本研究评估了接受单药或辅助治疗的患者 24 小时 IOP 降低的情况。
数据库研究。
年龄在 41 至 79 岁之间的原发性开角型青光眼或高眼压症患者。
回顾性分析了 66 例接受拉坦前列素、曲伏前列素、噻吗洛尔或溴莫尼定单药治疗,52 例接受拉坦前列素单药治疗联合布林佐胺或噻吗洛尔治疗的患者双眼 24 小时 IOP 数据。在药物治疗至少 4 周之前和之后,在睡眠实验室中每 2 小时测量一次 IOP。分析了单眼 IOP 降低的单一配对和双眼在办公时间、白天、夜间和 24 小时期间以及不同体位时的平均 IOP 降低的关联强度。
差异方差、大绝对差异百分比分布和配对 IOP 降低的决定系数(r²)。
在单药和辅助治疗下,所有时间段和体位下,单眼 IOP 降低均值的差异标准差均大于 2.5mmHg。单眼 IOP 降低绝对值大于 3mmHg 和 2mmHg 的差值分别超过 20%和 36%。相应的决定系数为 0.240 至 0.374(单药治疗)和 0.215 至 0.381(辅助治疗)。当分析特定时间段和体位的双眼 IOP 降低平均值时,双眼 IOP 降低差异的标准差和大绝对差异的百分比分布降低,并且大多数决定系数得到改善。
当考虑单眼 IOP 降低的单药或辅助治疗时,在 24 小时期间,右眼和左眼对眼压降低的反应之间仅有微弱的相关性。考虑多个配对 IOP 反应的平均值可以提高相关性的强度。
作者在本文讨论的任何材料中均没有专有的或商业的利益。