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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

BMJ open, 2021-02, Vol.11 (2), p.e043371-e043371 [Peer Reviewed Journal]

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. ;2021 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. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;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. 2021 ;ISSN: 2044-6055 ;EISSN: 2044-6055 ;DOI: 10.1136/bmjopen-2020-043371 ;PMID: 33619191

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  • Title:
    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
  • Author: 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
  • Subjects: Adult ; Blood pressure ; Cataracts ; Consent ; Diabetes ; Diabetes Mellitus ; Diabetic retinopathy ; Diabetic Retinopathy - surgery ; Disease ; Edema ; Glaucoma ; Humans ; Laser Coagulation ; Macular Edema ; Ophthalmology ; Quality of Life ; Randomized Controlled Trials as Topic ; Retina ; Surgery ; Treatment Outcome ; Vascular endothelial growth factor ; Vitrectomy
  • Is Part Of: BMJ open, 2021-02, Vol.11 (2), p.e043371-e043371
  • Description: IntroductionDiabetic 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 analysisThis 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 disseminationThe 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 numberNCT04103671.
  • Publisher: England: BMJ Publishing Group LTD
  • Language: English
  • Identifier: ISSN: 2044-6055
    EISSN: 2044-6055
    DOI: 10.1136/bmjopen-2020-043371
    PMID: 33619191
  • Source: ProQuest One Psychology
    Geneva Foundation Free Medical Journals
    BMJ Open Access Journals
    PubMed Central (Open access)
    AUTh Library subscriptions: ProQuest Central
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