Microinvasive pars plana vitrectomy versus panretinal photocoagulation in the treatment of severe non-proliferative diabetic retinopathy (the VIP study): study protocol for a randomised controlled trial

Wenbin Zheng, Shida Chen, Xiaohu Ding, Kunbei Lai, Sainan Xiao, Ying Lin, Bingqian Liu, Ling Jin, Jizhu Li, Yuqing Wu, Yuan Ma, Lin Lu, Yizhi Liu, Tao Li, Wenbin Zheng, Shida Chen, Xiaohu Ding, Kunbei Lai, Sainan Xiao, Ying Lin, Bingqian Liu, Ling Jin, Jizhu Li, Yuqing Wu, Yuan Ma, Lin Lu, Yizhi Liu, Tao Li

Abstract

Introduction: 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.

Methods and analysis: 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.

Ethics and dissemination: 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.

Trial registration number: NCT04103671.

Keywords: diabetic retinopathy; ophthalmology; vetreoretinal.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Participant flow diagram. d, day; m, month; PPV, pars plana vitrectomy; PRP, panretinal photocoagulation; sNPDR, severe non-proliferative diabetic retinopathy; w, week.
Figure 2
Figure 2
Seven standard-field fundus photography. (A) Pattern diagram, field 1 is centred on the optic disc, field 2 on the macula, field 3 is temporal to the macula and fields 4–7 are tangential to horizontal lines passing through the upper and lower poles of the disc and to a vertical line passing through its centre. (B) Stitched fundus photograph.

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