Jianping Liu, Nathan Congdon, Lixia Luo, Ling Jin, Xiaotong Han, Mingguang He, Lanhua Wang, Bo Qu, Zhenzhen Liu, Xiaoyun Chen, Ye Dai, Enen Zhang, Guangming Jin, Yizhi Liu, and Wei Wang
IMPORTANCE: The conventional 2.2-mm clear corneal incision is relatively narrow compared with the sleeves of Phaco handpieces, resulting in friction at the incision site and increased risk of incision-related Descemet membrane detachment (DMD). The modified 2.2-mm incision only enlarged internal width to 3.0 mm, forming a trapezoid incision shape, which may reduce the friction of surgical instruments and decrease the risk of incisional DMD. OBJECTIVE: To compare the incidence of incision-related DMD between eyes undergoing modified vs conventional 2.2-mm incision phacoemulsification for hard nuclear age-related cataract. DESIGN, SETTING, AND PARTICIPANTS: This double-masked, parallel randomized clinical trial was conducted from July 22, 2019, to January 22, 2020, at Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China. The study included patients with age-related cataract and nuclear opalescence grade of 4.0 or greater based on the Lens Opacities Classification System III. Patients were enrolled in this study according to the following inclusion criteria: (1) age between 65 to 90 years; (2) pupil size of 6 mm or greater after dilation; (3) Lens Opacities Classification System III nuclear opalescence grade of 4.0 or more; and (4) corneal endothelial cell density greater than 1500 cells/mm(2). INTERVENTIONS: Modified (enlarged internal width to 3.0 mm) or conventional 2.2-mm incision phacoemulsification with intraocular lens implantation. MAIN OUTCOMES AND MEASURES: Incidence of incision-related DMD at postoperative day 1. RESULTS: A total of 130 eyes of 130 patients were randomized into the conventional group (n = 65) or the modified group (n = 65). The mean (SD) age of participants was 74.5 (5.9) years and 74.3 (6.0) years in the conventional and modified groups, respectively. A total of 26 participants in the conventional group (40%) and 27 in the modified group (42%) were men. Compared with eyes in the conventional group, the incidence of DMD in eyes in the modified group was significantly lower at postoperative day 1 (difference, 26.15; 95% CI, 9.60-42.71; P = .003). The difference at postoperative day 7 was 16.92 (95% CI, 2.91-30.94; P = .02). The length of DMD (postoperative day 1: difference, 0.188; 95% CI, 0.075-0.301; P = .002) and maximal corneal thickness at incision site (postoperative day 1: difference, 0.032; 95% CI, 0.006-0.057; P = .02; postoperative day 7: difference, 0.019; 95% CI, 0.003-0.035; P = .02) were lower in the modified group, while visual quality parameter modulation transfer function (postoperative day 1: difference, −0.033; 95% CI, −0.064 to −0.001; P = .04) was higher. No difference was observed between the 2 groups in best-corrected visual acuity, central corneal endothelium loss, or surgically induced astigmatism at any follow-up time. There were no intraoperative complications in the 2 groups. CONCLUSIONS AND RELEVANCE: These findings suggest that modified 2.2-mm trapezoid incision phacoemulsification reduces the incidence of DMD for hard nuclear age-related cataract at postoperative day 1 and might be considered in patients at high risk of incision-related DMD, although the clinical relevance cannot be determined with certainty from this trial. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04014699