Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
08/H0716/70
Study information
Scientific title
Effect of low vision rehabilitation on self-reported visual disability for people with diabetic eye disease: a randomised controlled trial.
Acronym
Study hypothesis
This study aims to determine the efficacy of low vision rehabilitation on people with diabetic eye disease using a delayed intervention randomised controlled trial.
Ethics approval
National Hospital for Neurology and Neurosurgery and Institute of Neurology Joint REC, 16/10/2008, ref: 08/H0716/70
Study design
Randomised delayed-intervention controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Diabetic eye disease
Intervention
The intervention is a Low Vision Assessment (LVA) and will conform to the standard care provided to all low vision patients at Moorfields Eye Hospital.
This includes:
1. Check patient's understanding of their eye condition
2. Discuss needs/visual requirements and set initial goals
3. Assess distance and near vision
4. Determine appropriate levels of magnification required
5. Demonstrate selected low vision aids based on the results of the vision assessment and patient goals
6. Determine which visual aids are to be prescribed and review their use and handling
7. Discuss lighting and other methods of enhancing vision as appropriate
8. Discuss other services that may be available to the patient (e.g., social services, charities)
9. Dispense prescribed low vision aids on loan
10. Arrange for follow-ups as necessary
The intervention arm will receive LVA assessment at month 0. The control arm will receive delayed intervention at month 3. Both groups will be followed up for 6 months from study enrolment.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Self-reported visual disability as measured by the Massof Activity Inventory questionnaire at 0, 3 and 6 months
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/04/2009
Overall trial end date
30/09/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Both males and females
2. Patients with diabetes mellitus attending Moorfields Diabetic Clinics
3. Patients with diabetic eye disease as defined by an ophthalmologist
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Patients under the age of 18
2. Patients who are not fluent in English
3. Patients with serious hearing impairment
4. Patients with concomitant eye disease (other than mild cataract)
5. Patients who have previously attended a Low Vision Clinic
6. Patients with poor mobility or in poor general health
7. Patients who are hospital inpatients, living in nursing homes or who are otherwise non-independent
Recruitment start date
01/04/2009
Recruitment end date
30/09/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London (UCL) Institute of Ophthalmology
London
EC1V 9EL
United Kingdom
Sponsor information
Organisation
Moorfields Eye Hospital NHS Foundation Trust (UK)
Sponsor details
c/o Ms Sue Lydeard
Research and Development Department
162 City Road
London
EC1V 2PD
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Fight for Sight (UK) - Clinical Fellowship Grant (ref: 1775/76)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
2013 results published in thesis http://discovery.ucl.ac.uk/1393954/
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22620493
Publication citations
-
Protocol
Dunbar HM, Crossland MD, Bunce C, Egan C, Rubin GS, The effect of low vision rehabilitation in diabetic eye disease: a randomised controlled trial protocol., Ophthalmic Physiol Opt, 2012, 32, 4, 282-293, doi: 10.1111/j.1475-1313.2012.00914.x.