State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, China.
Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.
JAMA Ophthalmol. 2023 Jun 1;141(6):574-581. doi: 10.1001/jamaophthalmol.2023.1491.
During phacoemulsification, incision leakage and the subsequent anterior chamber collapse often occur after the withdrawal of the handpiece, which cannot be prevented by current sealing techniques. A new technique called swab pressing is proposed here to apply pressure with a cotton swab to seal the incision immediately, but efficacy remains unknown.
To determine if swab pressing is noninferior to stromal hydration, the current practice, in sealing incisions in phacoemulsification for age-related cataract.
DESIGN, SETTING, AND PARTICIPANTS: This noninferiority randomized controlled clinical trial was conducted between February 2022 and September 2022 at the Zhongshan Ophthalmic Center, Guangzhou, China. Patients aged 60 to 90 years with age-related cataract were enrolled.
Participants were randomly assigned (1:1) to receive swab pressing or stromal hydration. All surgeries were performed by a single experienced surgeon who was unmasked to the assignment.
The proportion of closed clear corneal incisions evaluated using intraoperative optical coherence tomography.
A total of 126 eyes of 126 participants were randomized into the swab pressing group (63 [50%]) and stromal hydration group (63 [50%]). The mean (SD) age of participants was 69.2 (6.14) years and 70.1 (7.67) years in the pressing and stromal hydration groups, respectively. A total of 39 participants (61.9%) in the pressing group and 35 (55.6%) in the modified group were female. The proportion of closed incisions was 96.8% (61 of 63) in the swab pressing group and 93.7% (59 of 63) in the stromal hydration group. Noninferiority was met, as the lower 95% CI of -5.83 percentage points was greater than the prescribed noninferiority margin of -6.60 percentage points (difference, 3.17 percentage points; 95% CI, -5.83 to 12.18 percentage points). The rate of anterior chamber collapse (pressing: 0 of 63 vs stromal hydration: 35 of 63 [55.6%]; P < .001) was lower in the swab pressing group. There were no differences between the 2 groups in the proportion of closed incisions and central anterior chamber depth at postoperative hour 1 and day 1.
In this study, swab pressing was noninferior to stromal hydration in sealing clear corneal incisions in phacoemulsification for age-related cataract. While this trial involved only 1 surgeon who was not masked to the interventions, the results suggest that swab pressing is feasible and further investigations would be warranted to determine if it prevents the intraoperative transient collapse of anterior chamber or affects visual acuity outcomes.
ClinicalTrials.gov Identifier: NCT05242653.
在白内障超声乳化术中，当器械撤出后切口常常会发生渗漏和前房塌陷，目前的密封技术无法预防这种情况。这里提出了一种新的技术，称为棉签按压，即用棉签施加压力立即密封切口，但疗效尚不清楚。
确定棉签按压是否不劣于基质水化，即当前的实践，用于密封白内障超声乳化术治疗年龄相关性白内障的切口。
设计、地点和参与者：这是一项 2022 年 2 月至 2022 年 9 月在中国广州中山眼科中心进行的非劣效性随机对照临床试验。招募了年龄在 60 至 90 岁之间的年龄相关性白内障患者。
参与者被随机分配（1:1）接受棉签按压或基质水化。所有手术均由一名经验丰富的单名外科医生进行，该医生对手术分配情况不知情。
术中使用光学相干断层扫描评估闭合透明角膜切口的比例。
共有 126 名参与者的 126 只眼被随机分配到棉签按压组（63 只[50%]）和基质水化组（63 只[50%]）。参与者的平均（SD）年龄分别为按压组 69.2（6.14）岁和基质水化组 70.1（7.67）岁。按压组中共有 39 名（61.9%）参与者和 35 名（55.6%）参与者为女性。棉签按压组的闭合切口比例为 96.8%（61/63），基质水化组为 93.7%（59/63）。符合非劣效性标准，下限为-5.83 个百分点，大于规定的-6.60 个百分点非劣效性边界（差值为 3.17 个百分点；95%置信区间为-5.83 至 12.18 个百分点）。棉签按压组前房塌陷的发生率（按压组：0/63 与基质水化组：35/63 [55.6%]；P<0.001）较低。两组在术后 1 小时和 1 天的闭合切口比例和中央前房深度方面无差异。
在这项研究中，棉签按压在密封白内障超声乳化术中治疗年龄相关性白内障的透明角膜切口方面不劣于基质水化。虽然这项试验只涉及一名未对干预措施进行盲法的外科医生，但结果表明棉签按压是可行的，需要进一步研究以确定其是否可以防止术中前房短暂塌陷或影响视力结果。
ClinicalTrials.gov 标识符：NCT05242653。
