Zheng Wenbin, Chen Shida, Ding Xiaohu, Lai Kunbei, Xiao Sainan, Lin Ying, Liu Bingqian, Jin Ling, Li Jizhu, Wu Yuqing, Ma Yuan, Lu Lin, Liu Yizhi, Li Tao
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China
BMJ Open. 2021 Feb 22;11(2):e043371. doi: 10.1136/bmjopen-2020-043371.
Diabetic retinopathy (DR) is the main cause of adult visual impairment worldwide. Severe non-proliferative DR (sNPDR) is an important clinical intervention stage. Currently, panretinal photocoagulation (PRP) is the standard treatment for sNPDR. However, PRP alone cannot completely prevent NPDR progression. One explanation might be that PRP does not remove the detrimental vitreous that plays an important role in DR progression. Microinvasive pars plana vitrectomy (PPV) was shown to be a safe and effective method to treat late-stage proliferative DR (PDR) by completely removing the pathological vitreous. However, whether PPV is effective in controlling sNPDR remains unknown. In this trial, we aim to compare the effectiveness of microinvasive PPV with that of PRP for sNPDR progression control.
This single centre, parallel group, randomised controlled trial aims to evaluate the clinical efficacy of microinvasive PPV in preventing the progression of sNPDR compared with PRP. A total of 272 adults diagnosed with sNPDR will be randomised 1:1 to the microinvasive PPV and PRP groups. The primary outcome is the disease progression rate, calculated as the rate of sNPDR progressed to PDR from baseline to 12 months after treatment. The secondary outcomes include the change in best-corrected visual acuity, re-treatment rate, diabetic macular oedema occurrence, change in central retinal thickness, change in the visual field, cataract occurrence and change in the quality of life.
The Ethics Committee of Zhongshan Ophthalmic Center approved this study (2019KYPJ108). The results will be presented at scientific meetings and submitted for publication to peer-reviewed journals.
NCT04103671.
糖尿病视网膜病变（DR）是全球成年人视力损害的主要原因。重度非增殖性糖尿病视网膜病变（sNPDR）是一个重要的临床干预阶段。目前，全视网膜光凝（PRP）是sNPDR的标准治疗方法。然而，单纯PRP并不能完全阻止NPDR的进展。一种解释可能是PRP并不能清除在DR进展中起重要作用的有害玻璃体。微创玻璃体切除术（PPV）被证明是一种通过完全清除病理性玻璃体来治疗晚期增殖性糖尿病视网膜病变（PDR）的安全有效方法。然而，PPV在控制sNPDR方面是否有效仍不清楚。在本试验中，我们旨在比较微创PPV与PRP在控制sNPDR进展方面的有效性。
本单中心、平行组、随机对照试验旨在评估与PRP相比，微创PPV在预防sNPDR进展方面的临床疗效。总共272名被诊断为sNPDR的成年人将按1:1随机分为微创PPV组和PRP组。主要结局是疾病进展率，计算为从基线到治疗后12个月sNPDR进展为PDR的比率。次要结局包括最佳矫正视力的变化、再次治疗率、糖尿病性黄斑水肿的发生、中心视网膜厚度的变化、视野的变化、白内障的发生以及生活质量的变化。
中山大学中山眼科中心伦理委员会批准了本研究（2019KYPJ108）。研究结果将在科学会议上公布，并提交给同行评审期刊发表。
NCT04103671。
