scholarly journals Two-step versus 1-step subretinal injection to compare subretinal drug delivery: a randomised study protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e049976
Author(s):  
Matthew P Simunovic ◽  
Emily H Shao ◽  
Perach Osaadon ◽  
Muhammad Bayu Sasongko ◽  
Lay Khoon Too
Keyword(s):  
Controlled Trial ◽  
Age Related Macular Degeneration ◽  
Subretinal Space ◽  
Sodium Fluorescein ◽  
Local Health ◽  
Randomised Study ◽  
Human Research Ethics ◽  
Age Related ◽  
Randomised Controlled ◽  
Subretinal Injection

IntroductionThere is increasing interest in subretinal injections as a surgical procedure, largely as a result of emerging treatments for ocular diseases which necessitate this manoeuvre. However, surgical variables in the efficacy of such treatments have to date been largely overlooked and the proportion of drug which reaches the intended compartment of the subretinal space remains unknown. Our aims are twofold: first, to determine the proportion of subretinally injected medication retained following surgical delivery and second, to compare two different techniques of injection (‘1-step’ vs ‘2-step’).MethodsWe outline a randomised controlled trial of subretinal injection of alteplase following vitrectomy for the management of submacular haemorrhage secondary to age-related macular degeneration. Patients will be randomised to receive either 1-step injection, where the therapeutic solution simultaneously defines the surgical plane or 2-step injection, where the surgical plane is first identified with balanced salt solution prior to injection of subretinal alteplase, as outlined below. Sodium fluorescein will be used as an optical label to track drug reflux into the vitreous cavity using quantitative protocols established in our laboratory. All patients will undergo fluid air exchange at the completion of surgery, with injection of bevacizumab 1.25 mg and 20% sulfahexafluoride gas as the vitreous substitute (both of which may help improve outcomes). Alteplase, sodium fluorescein and bevacizumab will all be used for off-label indications in the trial.Ethics and disseminationEthical approval has been obtained from the South Eastern Sydney Local Health District’s Human Research Ethics Committee (HREC 17/092). The results of this trial will be disseminated in peer-reviewed proceedings (associated with conference presentation) and in scholarly journals.Trial registration numberACTRN12619001121156.

scholarly journals Dietary intervention in patients with age-related macular degeneration: protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e024774 ◽  
Author(s):  
Diana Tang ◽  
Paul Mitchell ◽  
Victoria Flood ◽  
Annette Kifley ◽  
Alison Hayes ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Macular Degeneration ◽  
Dietary Intervention ◽  
Controlled Trial ◽  
Empirical Evaluation ◽  
Age Related Macular Degeneration ◽  
Dietary Recommendations ◽  
Phone Calls ◽  
Age Related ◽  
Randomised Controlled

IntroductionAge-related macular degeneration (AMD) is a leading cause of blindness. After smoking, nutrition is the key modifiable factor in reducing AMD incidence and progression, and no other preventative treatments are currently available. At present, there is an evidence–practice gap of dietary recommendations made by eye care practitioners and those actually practised by patients with AMD. To address this gap, a telephone-delivered dietary intervention tailored to patients with AMD will be piloted. The study aims to improve dietary intake and behaviours in patients with AMD. This type of nutrition-focused healthcare is currently not considered in the long-term management of AMD and represents the first empirical evaluation of a telephone-supported application encouraging adherence to dietary recommendations for AMD.Methods and analysis140 participants with AMD will be recruited for this randomised controlled trial. Those lacking English fluency; unwilling to engage in the intervention or provide informed consent were excluded. Following the completion of the baseline questionnaire, participants will be randomised into one of two arms: intervention or wait-list control (70 each in the intervention and control groups). Intervention participants will receive a detailed mail-delivered workbook containing information on healthy eating behaviours that promote optimal macular health, as well as scheduled phone calls over 4 months from an accredited practising dietitian. Descriptive statistics and multivariate stepwise linear regressions analyses will be used to summarise and determine the changes in dietary intakes, respectively. Economic analysis will be conducted to determine intervention feasibility and possibility of a large-scale rollout.Ethics and disseminationThe study was approved by the University of Sydney Human Research Ethics Committee (HREC) (Reference: HREC 2018/219). Study findings will be disseminated via presentations at national/international conferences and peer-reviewed journal articles.Trial registration numberACTRN12618000527268; Pre-results.

scholarly journals Implementing a multi-modal support service model for the family caregivers of persons with age-related macular degeneration: a study protocol for a randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e018204 ◽  
Author(s):  
Bamini Gopinath ◽  
Ashley Craig ◽  
Annette Kifley ◽  
Gerald Liew ◽  
Jaye Bloffwitch ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Family Caregivers ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Support Service ◽  
Age Related Macular Degeneration ◽  
Age Related ◽  
Cognitive Behavioural ◽  
Registration Number ◽  
Randomised Controlled

IntroductionAge-related macular degeneration (AMD) is a leading cause of blindness and low vision among older adults. Previous research shows a high prevalence of distress and disruption to the lifestyle of family caregivers of persons with late AMD. This supports existing evidence that caregivers are ‘hidden patients’ at risk of poor health outcomes. There is ample scope for improving the support available to caregivers, and further research should be undertaken into developing services that are tailored to the requirements of family caregivers of persons with AMD. This study aims to implement and evaluate an innovative, multi-modal support service programme that aims to empower family caregivers by improving their coping strategies, enhancing hopeful feelings such as self-efficacy and helping them make the most of available sources of social and financial support.Methods and analysisA randomised controlled trial consisting of 360 caregiver–patient pairs (180 in each of the intervention and wait-list control groups). The intervention group will receive the following: (1) mail-delivered cognitive behavioural therapy designed to improve psychological adjustment and adaptive coping skills; (2) telephone-delivered group counselling sessions allowing caregivers to explore the impacts of caring and share their experiences; and (3) education on available community services/resources, financial benefits and respite services. The cognitive behavioural therapy embedded in this programme is the best evaluated and widely used psychosocial intervention. The primary outcome is a reduction in caregiver burden. Secondary outcomes include improvements in caregiver mental well-being, quality of life, fatigue and self-efficacy. Economic analysis will inform whether this intervention is cost-effective and if it is feasible to roll out this service on a larger scale.Ethics and disseminationThe study was approved by the University of Sydney human research ethics committee. Study findings will be disseminated via presentations at national/international conferences and peer-reviewed journal articles.Trial registration numberThe trial registration number is ACTRN12616001461482; pre-results.

scholarly journals Accounting for health literacy and intervention preferences when reducing unhealthy snacking: protocol for an online randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e028544 ◽  
Author(s):  
Julie Ayre ◽  
Erin Cvejic ◽  
Carissa Bonner ◽  
Robin M Turner ◽  
Stephen D Walter ◽  
...  
Keyword(s):  
Health Literacy ◽  
Action Plan ◽  
Controlled Trial ◽  
Local Health ◽  
Random Allocation ◽  
Literacy Interventions ◽  
Human Research Ethics ◽  
Volitional Strategies ◽  
Randomised Controlled ◽  
The Impact

IntroductionHealth literacy describes the cognitive and social skills that individuals use to access, understand and act on health information. Health literacy interventions typically take the ‘universal precautions approach’ where all consumers are presented with simplified materials. Although this approach can improve knowledge and comprehension, its impact on complex behaviours is less clear. Systematic reviews also suggest that health literacy interventions underuse volitional strategies (such as planning) that play an important role in behaviour change. A recent study found volitional strategies may need to be tailored to the participant’s health literacy. The current study aims to replicate these findings in a sample of people who have diabetes and/or are overweight or obese as measured by body mass index, and to investigate the most effective method of allocating an action plan to a participant to reduce unhealthy snacking.Methods and analysisWe plan to recruit approximately 2400 participants at baseline. Participants will receive one of two alternative online action plans intended to reduce unhealthy snacking (‘standard’ action plan or ‘literacy-sensitive’ action plan). Participants will be randomised to a method of allocation to an action plan: (1) random allocation; (2) allocation by health literacy screening tool or (3) allocation by participant selection. Primary outcome is self-reported serves of unhealthy snacks during the previous month. Multiple linear regression will evaluate the impact of health literacy on intervention effectiveness. The analysis will also identify independent contributions of each action plan, method of allocation, health literacy and participant selections on unhealthy snacking at 4-week follow-up.Ethics and disseminationThis study was approved by the University of Sydney Human Research Ethics Committee (2017/793). Findings will be disseminated through peer-reviewed international journals, conferences and updates with collaborating public health bodies (Diabetes New South Wales (NSW) & Australian Capital Territory (ACT), and Western Sydney Local Health District).Trial registration numberACTRN12618001409268; Pre-results.

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