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DEPVIT: Depression in Visual Impairment Trial

Funder

Guide Dogs

Webpage

http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=10267

http://www.isrctn.com/ISRCTN46824140

Registration number

ISRCTN: 46824140

Collaborating Investigators/Institutions:

Dr. Tom Margrain, Cardiff University

Project Summary

The aim of the DEPVIT trial is to a) estimate the prevalence of depressive symptoms using the Geriatric Depression Scale (GDS-15) in an observational study of consecutive attendees of low vision services in England and Wales; b) compare 2 interventions (problem-solving therapy and GP referral) against a waiting list control for newly-diagnosed low vision patients with depressive symptoms; and c) to obtain economic information about the cost to roll-out a psychological problem solving based intervention for people experiencing sight loss and how well standard economic tools work with people experiencing sight loss to analyse the cost-effectiveness of the interventions. The primary outcome measure is change (baseline – 3 & 6 month follow up) in depressive symptoms as measured by the Beck’s Depression Inventory (BDI-II). The population studied was people with a visual impairment with an appointment for a low vision assessment. The results are currently being analysed.

The p-EVES Study: The effectiveness of portable electronic vision enhancement systems (EVES) in comparison to optical magnifiers for near vision activities in visual impairment

Funder

NIHR Central Commissioning Facility

Webpage

http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=13663

https://clinicaltrials.gov/show/NCT01701700

Registration number

ClinicalTrial.gov: NCT01701700

Collaborating Investigators/Institutions:

Prof. Christine Dickinson, University of Manchester

Project Summary

This prospective definitive study is a two-arm randomised cross-over study to determine the effectiveness and acceptability of portable Electronic Vision Enhancement System (p-EVES) devices and conventional optical low vision aids (LVAs) for near tasks. Participants are adults who have a visual impairment secondary to a stable ocular pathology and currently possess a near vision optical magnifying device. 2 interventions are being used: Intervention A is a two month period with conventional optical devices and Intervention B is a two month period with the conventional optical devices and the p-EVES. Group one will receive the two interventions A and B in the order AB, while Group two will receive the interventions in the order BA. The primary outcome measures are “usage” of devices and reading speed measured using the The MNRead test. From a health economics perspective, we will examine the incremental cost-effectiveness of the p-EVES low vision aid compared to conventional LVAs.

Adjunctive Steroid Combination in Ocular Trauma (ASCOT) Study: A phase 3 multi-centre double-masked randomised controlled trial of adjunctive intraocular and periocular steroid (triamcinolone acetonide) versus standard treatment in eyes undergoing vitreoretinal surgery for open globe trauma

Funder

NIHR – Health Technology Assessment (HTA)

Webpage

UKCRN page http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=17226

Registration number

ISRCTN: 30012492;
EudraCT: 2014-002193-37

Collaborating Investigators/Institutions:

Mr. David G Charteris, Moorfields Eye Hospital

Project Summary

The ASCOT study is a phase 3, double-masked, randomised, multi-site trial in patients undergoing pars plana vitrectomy following open globe trauma with an internal pilot. This study aims to test the hypothesis that adjunctive triamcinolone acetonide, given at the time of surgery, can improve the outcome of vitreoretinal surgery for open-globe ocular trauma.  The study will specifically analyse the influence of the study intervention on visual acuity, the incidence of retinal detachment and the development of scarring (proliferative vitreoretinopathy) in patients with open globe trauma. Quality of life assessment will be undertaken on the study patients and a cost-effectiveness analysis carried out. In total 300 patients will be recruited and randomly allocated to two treatment arms from 20 sites throughout the U.K. The primary outcome will be best corrected visual acuity measured at 6 months. 

Clinical Efficacy and Mechanistic Evaluation of Aflibercept for Proliferative Diabetic Retinopathy (CLARITY): A Multicentre Phase IIb Randomised Active-Controlled Clinical trial

Funder

MRC

Registration number

ISRCTN: 32207582

Collaborating Investigators/Institutions:

Dr. Sobha Sivaprasad, NIHR Moorfields Biomedical Research Centre

Project Summary

The CLARITY trial is a phase IIb randomised controlled single-masked multicentre clinical trial to determine the impact of repeated intravitreal aflibercept injections in the treatment and prevention of proliferative diabetic retinopathy. The aim of this randomised controlled trial is to determine the efficacy, safety, and cost-effectiveness of intravitreal aflibercept, an inhibitor of VEGF-A, VEGF-B and Placental Growth factor (PLGF), in proliferative diabetic retinopathy, and to investigate the impact on local oxygenation. 220 subjects with treatment-naïve or treated but active retinal neovascularisation in at least one eye will be randomly allocated 1:1 to intravitreal aflibercept injections or panretinal photocoagulation for a period of 52 weeks.  The primary outcome is the change in best-corrected visual acuity in the study eye at 52 weeks.  Secondary outcomes include changes from baseline in other visual functions, anatomical changes and cost-effectiveness.

Wellbeing, health and fitness of children with mobility impairments (Well MI); Scoping and development of individually tailored child-centred ‘keep-fit’ interventions

Funder

NISCHR CRC Research Funding Scheme: Health Award

Webpage

http://wellmi.bangor.ac.uk/

Collaborating Investigators/Institutions:

Dr. Thomas D. O’Brien, Liverpool John Moores University; Prof. Jane Noyes, Bangor University

Project Summary

Children with mobility impairments typically have low activity levels and are more likely to be obese and develop type-2 diabetes and cardiovascular disease in later life. The Well MI study aims establish children's perspectives and needs in order to develop individually tailored, child-centred and fun keep fit interventions to improve the wellbeing, health and fitness of children with mobility impairments. Qualitative interviews were used to identify important outcomes for children with mobility impairments and their families; develop assessment methods; and explore preferences for exercise (e.g. motivation, location, duration, individual/group, music). Individual/condition-specific cases will be examined using baseline data to develop fun child-centred activities. At completion, a protocol for a pilot trial to test individually-tailored interventions and assess cost-effectiveness, will be designed.

A Cost-Consequence Analysis of SeeAbility’s Children in Focus Campaign

Webpage

www.seeability.org

Project Summary

The 'Children In Focus' campaign, strives for consistent and appropriate eye care for children with disabilities attending special need schools. The campaign's main purpose is to increase the availability of eye tests in order that potential eye conditions are detected early. The aim of the cost-consequence analysis was to calculate and describe the costs and consequences of providing sight tests to children with disabilities in special schools in demonstration sites in England.

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