Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Department of Ophthalmology, University of Colorado Anschutz Medical Campus, Denver, Colorado, USA.
Cochrane Database Syst Rev. 2021 May 27;5(5):CD012830. doi: 10.1002/14651858.CD012830.pub2.
Cataract surgery is one of the most common surgical procedures performed worldwide. Achieving appropriate intraoperative mydriasis is one of the critical factors associated with the safety and performance of the surgery. Inadequate pupillary dilation or constriction of the pupil during cataract surgery can impair the surgeon's field of view and make it difficult to maneuver instruments.
To evaluate the relative effectiveness of achieving pupillary dilation during phacoemulsification for cataract extraction using three methods of pupillary dilation: topical mydriatics, intracameral mydriatics, or depot delivery systems. We also planned to document and compare the risk of intraoperative and postoperative complications following phacoemulsification for cataract extraction, as well as the cost-effectiveness of these methods for pupillary dilation.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), which contains the Cochrane Eyes and Vision Trials Register) (2021, Issue 1); Ovid MEDLINE; Embase.com; PubMed; Latin American and Caribbean Health Sciences Literature Database (LILACS); ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 22 January 2021.
We included only randomized controlled trial (RCTs) in which participants underwent phacoemulsification for cataract extraction.
We followed standard Cochrane methodology.
We included a total of 14 RCTs (1670 eyes of 1652 participants) in this review. Of the 14 trials, 7 compared topical versus intracameral mydriatics, 6 compared topical mydriatics versus depot delivery systems, and 1 compared all three methods. We were unable to calculate overall estimates of comparative effectiveness for most outcomes due to statistical heterogeneity among the estimates from individual studies or because outcome data were available from only a single study. Furthermore, the certainty of evidence for most outcomes was low or very low, due primarily to imprecision and risk of bias. Comparison 1: topical mydriatics versus intracameral mydriatics Four RCTs (739 participants, 757 eyes) of the 8 RCTs that had compared these two methods reported mean pupillary diameters at the time surgeons had performed capsulorhexis; all favored topical mydriatics, but heterogeneity was high (I = 95%). After omitting 1 RCT that used a paired-eyes design, evidence from three RCTs (721 participants and eyes) suggests that mean pupil diameter at the time of capsulorhexis may be greater with topical mydriatics than with intracameral mydriatics, but the evidence is of low certainty (mean difference 1.06 mm, 95% confidence interval (CI) 0.81 mm to 1.31 mm; I = 49%). Four RCTs (224 participants, 242 eyes) reported mean pupillary diameter at the beginning of cataract surgery; the effect estimates from all trials favored topical mydriatics, with very low-certainty evidence. Five RCTs (799 participants, 817 eyes) reported mean pupillary diameter at the end of cataract surgery. Data for this outcome from the largest RCT (549 participants and eyes) provided evidence of a small difference in favor of intracameral mydriasis. On the other hand, 2 small RCTs (78 participants, 96 eyes) favored topical mydriatics, and the remaining 2 RCTs (172 participants) found no meaningful difference between the two methods, with very low-certainty evidence. Five RCTs (799 participants, 817 eyes) reported total intraoperative surgical time. The largest RCT (549 participants and eyes) reported decreased total intraoperative time with intracameral mydriatics, whereas 1 RCT (18 participants, 36 eyes) favored topical mydriatics, and the remaining 3 RCTs (232 participants) found no difference between the two methods, with very low-certainty evidence. Comparison 2: topical mydriatics versus depot delivery systems Of the 7 RCTs that compared these two methods, none reported mean pupillary diameter at the time surgeons performed capsulorhexis. Six RCTs (434 participants) reported mean pupillary diameter at the beginning of cataract surgery. After omitting 1 RCT suspected to be responsible for high heterogeneity (I = 80%), meta-analysis of the other 5 RCTs (324 participants and eyes) found no evidence of a meaningful difference between the two methods, with very low-certainty evidence. Three RCTs (210 participants) reported mean pupillary diameter at the end of cataract surgery, with high heterogeneity among effect estimates for this outcome. Estimates of mean differences and confidence intervals from these three RCTs were consistent with no difference between the two methods. A fourth RCT reported only means for this outcome, with low-certainty evidence. Two small RCTs (118 participants) reported total intraoperative time. Surgical times were lower when depot delivery was used, but the confidence interval estimated from one trial was consistent with no difference, and only mean times were reported from the other trial, with very low-certainty evidence. Comparison 3: Intracameral mydriatics versus depot delivery systems Only one RCT (60 participants) compared intracameral mydriatics versus depot delivery system. Mean pupillary diameter at the time the surgeon performed capsulorhexis, phacoemulsification time, and cost outcomes were not reported. Mean pupil diameter at the beginning and end of cataract surgery favored the depot delivery system, with very low-certainty evidence. Adverse events Evidence from one RCT (555 participants and eyes) comparing topical mydriatics versus intracameral mydriatics suggests that ocular discomfort may be greater with topical mydriatics than with intracameral mydriatics at one week (risk ratio (RR) 10.57, 95% CI 1.37 to 81.34) and one month (RR 2.51, 95% CI 1.36 to 4.65) after cataract surgery, with moderate-certainty evidence at both time points. Another RCT (30 participants) reported iris-related complications in 11 participants in the intracameral mydriatics group versus no complications in the depot delivery system group, with very low-certainty evidence. Cardiovascular related adverse events were rarely mentioned.
AUTHORS' CONCLUSIONS: Data from 14 completed RCTs were inadequate to establish the superiority of any of three methods to achieve mydriasis for cataract surgery, based on pupillary dilation at different times during the surgery or on time required for surgery. Only one trial had a sample size adequate to yield a robust effect estimate. Larger, well-designed trials are needed to provide robust estimates for the comparison of mydriasis approaches for beneficial and adverse effects.
白内障手术是全球最常见的手术之一。在手术过程中实现适当的术中散瞳是与手术安全性和性能相关的关键因素之一。在白内障手术过程中，如果瞳孔扩张不足或收缩，会影响外科医生的视野，并使器械难以操作。
评估在白内障超声乳化手术中使用三种散瞳方法（局部滴眼剂、前房内滴眼剂和储库型滴眼剂）实现瞳孔扩张的相对有效性。我们还计划记录和比较白内障超声乳化术后术中及术后并发症的风险，并评估这些散瞳方法的成本效益。
我们检索了 Cochrane 中心对照试验注册库（CENTRAL）（2021 年第 1 期）；Ovid MEDLINE；Embase.com；PubMed；拉丁美洲和加勒比卫生科学文献数据库（LILACS）；临床试验.gov；以及世界卫生组织（WHO）国际临床试验注册平台（ICTRP）。我们在电子检索中没有对试验使用任何日期或语言限制。我们于 2021 年 1 月 22 日最后一次检索电子数据库。
我们仅纳入参与者接受白内障超声乳化手术的随机对照试验（RCT）。
我们遵循了标准的 Cochrane 方法。
本综述共纳入 14 项 RCT（1670 只眼，1652 名参与者）。在这 14 项试验中，7 项比较了局部滴眼剂与前房内滴眼剂，6 项比较了局部滴眼剂与储库型滴眼剂，1 项比较了这三种方法。由于个体研究的估计值存在统计学异质性，或者由于只有一项研究提供了结局数据，因此我们无法计算大多数结局的总体有效性估计值。此外，由于主要是不精确性和偏倚风险，大多数结局的证据确定性较低或非常低。
比较 1：局部滴眼剂与前房内滴眼剂 8 项比较这两种方法的 RCT 中有 4 项（739 名参与者，757 只眼）报告了外科医生行晶状体囊切开术时的平均瞳孔直径；所有结果均倾向于局部滴眼剂，但异质性很高（I = 95%）。在排除了一项使用配对眼设计的 RCT 后，来自三项 RCT（721 名参与者和眼）的证据表明，晶状体囊切开术时的平均瞳孔直径可能大于前房内滴眼剂，但证据的确定性较低（平均差值 1.06mm，95%置信区间（CI）0.81mm 至 1.31mm；I = 49%）。4 项 RCT（224 名参与者，242 只眼）报告了白内障手术开始时的平均瞳孔直径；所有试验的效应估计均有利于局部滴眼剂，具有低确定性证据。5 项 RCT（799 名参与者，817 只眼）报告了白内障手术结束时的平均瞳孔直径。最大 RCT（549 名参与者和眼）提供的数据表明，前房内滴眼剂对瞳孔直径的影响较小。另一方面，2 项小型 RCT（78 名参与者，96 只眼）有利于局部滴眼剂，其余 2 项 RCT（172 名参与者）发现两种方法之间无明显差异，证据确定性低。5 项 RCT（799 名参与者，817 只眼）报告了总手术时间。最大 RCT（549 名参与者和眼）报告术中总时间缩短，而 1 项 RCT（18 名参与者，36 只眼）有利于局部滴眼剂，其余 3 项 RCT（232 名参与者）发现两种方法之间无差异，证据确定性低。
比较 2：局部滴眼剂与储库型滴眼剂 在比较这两种方法的 7 项 RCT 中，没有一项报告外科医生行晶状体囊切开术时的平均瞳孔直径。6 项 RCT（434 名参与者）报告了白内障手术开始时的平均瞳孔直径。在排除了一项被怀疑存在高度异质性的 RCT（I = 80%）后，对其余 5 项 RCT（324 名参与者和眼）的荟萃分析发现，两种方法之间无明显差异，证据确定性低。3 项 RCT（210 名参与者）报告了白内障手术结束时的平均瞳孔直径，这一结局的效应估计值存在高度异质性。来自这三项 RCT 的估计值差异和置信区间与两种方法之间无差异一致。第四项 RCT 仅报告了这一结局的平均值，证据确定性低。两项小型 RCT（118 名参与者）报告了总手术时间。使用储库型滴眼剂时手术时间较短，但来自一项试验的估计值与无差异一致，而另一项试验仅报告了平均值，证据确定性低。
比较 3：前房内滴眼剂与储库型滴眼剂 只有一项 RCT（60 名参与者）比较了前房内滴眼剂与储库型滴眼剂。外科医生行晶状体囊切开术时、白内障超声乳化术时间和成本结局均未报告。开始和结束白内障手术时的平均瞳孔直径有利于储库型滴眼剂，证据确定性低。
不良事件 一项比较局部滴眼剂与前房内滴眼剂的 RCT（555 名参与者和眼）表明，与前房内滴眼剂相比，术后一周（风险比（RR）10.57，95%置信区间（CI）1.37 至 81.34）和一个月（RR 2.51，95%置信区间（CI）1.36 至 4.65）时，局部滴眼剂可能引起更大的眼部不适，具有中等确定性证据。另一项 RCT（30 名参与者）报告了 11 名参与者在前房内滴眼剂组发生虹膜相关并发症，而在储库型滴眼剂组无并发症，证据确定性低。心血管相关不良事件很少提及。
根据手术过程中不同时间的瞳孔扩张或手术所需时间，14 项已完成 RCT 的数据不足以确定三种方法中的任何一种方法在白内障手术中实现散瞳的优越性。只有一项试验的样本量足以产生稳健的效应估计值。需要更大、设计良好的试验来提供关于散瞳方法对有益和不良影响的稳健估计值。
