scholarly journals Proliferative diabetic retinopathy: treatment with xenon-arc photocoagulation. Interim report of multicentre randomised controlled trial.

BMJ ◽  
1977 ◽  
Vol 1 (6063) ◽  
pp. 739-741 ◽  
Keyword(s):  
Diabetic Retinopathy ◽  
Randomised Controlled Trial ◽  
Proliferative Diabetic Retinopathy ◽  
Controlled Trial ◽  
Interim Report ◽  
Randomised Controlled

39-LB: Individualised Screening for Diabetic Retinopathy: The ISDR Study—A Randomised Controlled Trial of Safety, Efficacy, and Cost-Effectiveness

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 39-LB
Author(s):  
DEBORAH MARY BROADBENT ◽  
AMU WANG ◽  
CHRISTOPHER P. CHEYNE ◽  
JAMES G. LATHE ◽  
IRENE M. STRATTON ◽  
...  
Keyword(s):  
Diabetic Retinopathy ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Randomised Controlled

scholarly journals 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 ◽  
Vol 11 (2) ◽  
pp. e043371
Author(s):  
Wenbin Zheng ◽  
Shida Chen ◽  
Xiaohu Ding ◽  
Kunbei Lai ◽  
Sainan Xiao ◽  
...  
Keyword(s):  
Diabetic Retinopathy ◽  
Randomised Controlled Trial ◽  
Pars Plana Vitrectomy ◽  
Controlled Trial ◽  
Diabetic Macular Oedema ◽  
Panretinal Photocoagulation ◽  
Progression Rate ◽  
Thickness Change ◽  
Pars Plana ◽  
Randomised Controlled

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.

scholarly journals Balloon or bougie for dilatation of benign oesophageal stricture? An interim report of a randomised controlled trial.

Gut ◽  
1988 ◽  
Vol 29 (12) ◽  
pp. 1741-1747 ◽  
Author(s):  
J G Cox ◽  
R K Winter ◽  
S C Maslin ◽  
R Jones ◽  
G K Buckton ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Interim Report ◽  
Oesophageal Stricture ◽  
Randomised Controlled

scholarly journals Individualised screening for diabetic retinopathy: the ISDR study—rationale, design and methodology for a randomised controlled trial comparing annual and individualised risk-based variable-interval screening

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e025788 ◽  
Author(s):  
Deborah M Broadbent ◽  
Christopher J Sampson ◽  
Amu Wang ◽  
Lola Howard ◽  
Abigail E Williams ◽  
...  
Keyword(s):  
Diabetic Retinopathy ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Screening Programme ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Variable Interval ◽  
Randomised Controlled ◽  
The Uk

IntroductionCurrently, all people with diabetes (PWD) aged 12 years and over in the UK are invited for screening for diabetic retinopathy (DR) annually. Resources are not increasing despite a 5% increase in the numbers of PWD nationwide each year. We describe the rationale, design and methodology for a randomised controlled trial (RCT) evaluating the safety, acceptability and cost-effectiveness of personalised variable-interval risk-based screening for DR. This is the first randomised trial of personalised screening for DR and the largest ophthalmic RCT in the UK.Methods and analysisPWD attending seven screening clinics in the Liverpool Diabetic Eye Screening Programme were recruited into a single site RCT with a 1:1 allocation to individualised risk-based variable-interval or annual screening intervals. A risk calculation engine developed for the trial estimates the probability that an individual will develop referable disease (screen positive DR) within the next 6, 12 or 24 months using demographic, retinopathy and systemic risk factor data from primary care and screening programme records. Dynamic, secure, real-time data connections have been developed. The primary outcome is attendance for follow-up screening. We will test for equivalence in attendance rates between the two arms. Secondary outcomes are rates and severity of DR, visual outcomes, cost-effectiveness and health-related quality of life. The required sample size was 4460 PWD. Recruitment is complete, and the trial is in follow-up.Ethics and disseminationEthical approval was obtained from National Research Ethics Service Committee North West – Preston, reference 14/NW/0034. Results will be presented at international meetings and published in peer-reviewed journals. This pragmatic RCT will inform screening policy in the UK and elsewhere.Trial registration numberISRCTN87561257; Pre-results.

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