scholarly journals Randomised controlled trial of posterior sub-Tenon triamcinolone as adjunct to panretinal photocoagulation for treatment of diabetic retinopathy

2009 ◽  
Vol 93 (6) ◽  
pp. 765-770 ◽  
Author(s):  
N Unoki ◽  
K Nishijima ◽  
M Kita ◽  
K Suzuma ◽  
D Watanabe ◽  
...  
BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e043371
Author(s):  
Wenbin Zheng ◽  
Shida Chen ◽  
Xiaohu Ding ◽  
Kunbei Lai ◽  
Sainan Xiao ◽  
...  

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.


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 ◽  
...  

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e025788 ◽  
Author(s):  
Deborah M Broadbent ◽  
Christopher J Sampson ◽  
Amu Wang ◽  
Lola Howard ◽  
Abigail E Williams ◽  
...  

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.


2019 ◽  
Author(s):  
Amelia Jane Lake ◽  
Jessica L Browne ◽  
Gwyneth Rees ◽  
Jane Speight

Abstract Background young adults with type 2 diabetes (aged 18-39 years) are at risk of early onset and rapid progression of diabetic retinopathy, the leading cause of blindness and vision loss in working age adults. Early detection via retinal screening can prevent most vision loss, yet uptake for this priority population is consistently lower than the general diabetes population. We aimed to test the effect of a tailored, evidence-based brief health behaviour change intervention (leaflet) on self-reported uptake, and previously identified social cognitive determinants of retinal screening.Methods a pragmatic, two-arm randomised controlled trial was conducted from September 2014 to April 2015. Participants were stratified by prior screening uptake (Yes/No) and randomly allocated to intervention (leaflet) or ‘usual care’ control (no leaflet). Primary outcome was self-reported screening uptake four weeks post-intervention for ‘No’ participants who had not previously screened for diabetic retinopathy. Secondary outcome variables were changes in knowledge, attitudes, normative beliefs, intention and behavioural skills for all participants, irrespective of prior screening behaviour. To assess intervention effects on secondary outcome variables, we conducted independent samples t-tests (two-tailed) on pre-post change scores.Results 129 young adults (26% no prior retinal screen) completed baseline; 101 completed post-intervention. Power to determine effect on the primary outcome was curtailed by low recruitment of individuals with no prior retinal screen and loss to follow-up. Country of birth, language spoken at home, and relationship status were significantly associated with study attrition. Significant intervention effect was observed for one secondary outcome variable: knowledge of diabetic retinopathy ( p =.03) with moderate effect (partial eta squared η 2 =.05); no adverse effects were reported. Control group participants received the leaflet at study completion.Conclusions this study confirms that a well-designed eye health and retinal screening promotion leaflet can increase knowledge of diabetic retinopathy, an important screening predictor. The study highlights the challenges of conducting ‘real-world’ health behaviour change research with this priority population, providing insights for clinicians and researchers. Strategies to recruit, engage and retain hard-to-reach populations are discussed including nonconventional alternatives to randomised controlled trial designs. Trial registration: ACTRN12614001110673, UTN No.: U1111-1161-9803. Registered 20 October 2014 - retrospectively registered https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367127.


2019 ◽  
Author(s):  
Amelia Jane Lake ◽  
Jessica L Browne ◽  
Gwyneth Rees ◽  
Jane Speight

Abstract Background: Young adults with type 2 diabetes (aged 18-39 years) are at risk of early onset and rapid progression of diabetic retinopathy, the leading cause of blindness and vision loss in working age adults. Early detection via retinal screening can prevent most vision loss, yet uptake among this priority population is consistently lower than the general diabetes population. We aimed to test the effect of a tailored, evidence-based brief health behaviour change intervention (leaflet) on self-reported uptake, and previously identified social cognitive determinants of retinal screening. Methods: A pragmatic, two-arm randomised controlled trial was conducted from September 2014 to April 2015. Participants were stratified by prior screening uptake (Yes/No) and randomly allocated to intervention (leaflet) or ‘usual care’ control (no leaflet). Primary outcome was self-reported screening uptake four weeks post-intervention for ‘No’ participants who had not previously screened for diabetic retinopathy. Secondary outcome variables were changes in knowledge, attitudes, normative beliefs, intention and behavioural skills for all participants, irrespective of prior screening behaviour. To assess intervention effects on secondary outcome variables, we conducted independent samples t-tests (two-tailed) on pre-post change scores. Results: 129 young adults (26% no prior retinal screen) completed baseline; 101 completed post-intervention. Power to determine effect on the primary outcome was curtailed by low recruitment of individuals with no prior retinal screen and loss to follow-up. Attrition was associated significantly with country of birth, language spoken at home, and marital status. Significant intervention effect was observed for one secondary outcome variable: knowledge of diabetic retinopathy (p=.03) with moderate effect (partial eta squared h2=.05); no adverse effects were reported. Control group participants received the leaflet at study completion. Conclusions: This study confirms that a well-designed eye health and retinal screening promotion leaflet can increase knowledge of diabetic retinopathy, an important screening predictor. The study highlights the challenges of conducting ‘real-world’ health behaviour change research with this priority population, providing insights for clinicians and researchers. Strategies to recruit, engage and retain hard-to-reach populations are discussed including nonconventional alternatives to randomised controlled trial designs. Trial registration: ACTRN12614001110673, UTN No.: U1111-1161-9803. Registered 20 October 2014 - retrospectively registered https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367127


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