Effectiveness and safety of early lens extraction during par plana vitrectomy for proliferative diabetes retinopathy with mild cataract: a randomized clinical trial
Authors:   State Key Laboratory of Ophthalmology, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510275, Guangdong Province, China, Feng Wei-Bo , Li Ying-Qi ,   The Affiliated Hospital of Guizhou Medical University, Guiyang 550004, Guizhou Province, China, Li Yong-Hao ,   State Key Laboratory of Ophthalmology, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510275, Guangdong Province, China; Guangzhou Aier Eye Hospital, Guangzhou 510000, Guangdong Province, China, Zhang Guo-Ming ,   Shenzhen Eye Hospital Affiliated to Jinan University, Shenzhen 518040, Guangdong Province, China, Wang Xian ,   The Affiliated Hospital of Guizhou Medical University, Guiyang 550004, Guizhou Province, China, Liu Bing-Qian ,   State Key Laboratory of Ophthalmology, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510275, Guangdong Province, China, Jin Ling ,   State Key Laboratory of Ophthalmology, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510275, Guangdong Province, China, Huang Yi-Nuo ,   State Key Laboratory of Ophthalmology, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510275, Guangdong Province, China, Yang Yang-Fan ,   State Key Laboratory of Ophthalmology, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510275, Guangdong Province, China, Chen Zi-Dong ,   State Key Laboratory of Ophthalmology, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510275, Guangdong Province, China, Ma Da-Hui ,   Shenzhen Eye Hospital Affiliated to Jinan University, Shenzhen 518040, Guangdong Province, China, Chen Qing-Shan ,   Shenzhen Eye Hospital Affiliated to Jinan University, Shenzhen 518040, Guangdong Province, China, Qin Chao-Jun ,   The Affiliated Hospital of Guizhou Medical University, Guiyang 550004, Guizhou Province, China, Feng Bing-Min ,   The Affiliated Hospital of Guizhou Medical University, Guiyang 550004, Guizhou Province, China, Yang Zhu-Min ,   The Affiliated Hospital of Guizhou Medical University, Guiyang 550004, Guizhou Province, China, Huang Xing ,   The Affiliated Hospital of Guizhou Medical University, Guiyang 550004, Guizhou Province, China, Yang Cheng-Jie ,   The Affiliated Hospital of Guizhou Medical University, Guiyang 550004, Guizhou Province, China, Liu Sheng-Hui ,   The Affiliated Hospital of Guizhou Medical University, Guiyang 550004, Guizhou Province, China, Wu Ming-Xing ,   State Key Laboratory of Ophthalmology, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510275, Guangdong Province, China
Published: February 2024

AIM: To evaluate the effectiveness and safety of early lens extraction during pars plana vitrectomy (PPV) for proliferative diabetic retinopathy (PDR) compared to those of PPV with subsequent cataract surgery.
METHODS: This multicenter randomized controlled trial was conducted in three Chinese hospitals on patients with PDR, aged >45y, with mild cataracts. The participants were randomly assigned to the combined (PPV combined with simultaneously cataract surgery, i.e., phacovitrectomy) or subsequent (PPV with subsequent cataract surgery 6mo later) group and followed up for 12mo. The primary outcome was the change in best-corrected visual acuity (BCVA) from baseline to 6mo, and the secondary outcomes included complication rates and medical expenses.
RESULTS: In total, 129 patients with PDR were recruited and equally randomized (66 and 63 in the combined and subsequent groups respectively). The change in BCVA in the combined group [mean, 36.90 letters; 95% confidence interval (CI), 30.35–43.45] was significantly better (adjusted difference, 16.43; 95%CI, 8.77–24.08; P<0.001) than in the subsequent group (mean, 22.40 letters; 95%CI, 15.55–29.24) 6mo after the PPV, with no significant difference between the two groups at 12mo. The overall surgical risk of two sequential surgeries was significantly higher than that of the combined surgery for neovascular glaucoma (17.65% vs 3.77%, P=0.005). No significant differences were found in the photocoagulation spots, surgical time, and economic expenses between two groups. In the subsequent group, the duration of work incapacity (22.54±9.11d) was significantly longer (P<0.001) than that of the combined group (12.44±6.48d).
CONCLUSION: PDR patients aged over 45y with mild cataract can also benefit from early lens extraction during PPV with gratifying effectiveness, safety and convenience, compared to sequential surgeries.