Effect of low vision rehabilitation on self-reported visual disability for people with diabetic eye disease

ISRCTN ISRCTN91672666
DOI https://doi.org/10.1186/ISRCTN91672666
Secondary identifying numbers 08/H0716/70
Submission date
10/02/2009
Registration date
16/02/2009
Last edited
05/10/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Gary Rubin
Scientific

University College London (UCL) Institute of Ophthalmology
Department of Visual Neuroscience
11-43 Bath Street
London
EC1V 9EL
United Kingdom

Study information

Study designRandomised delayed-intervention controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEffect of low vision rehabilitation on self-reported visual disability for people with diabetic eye disease: a randomised controlled trial.
Study objectivesThis 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(s)National Hospital for Neurology and Neurosurgery and Institute of Neurology Joint REC, 16/10/2008, ref: 08/H0716/70
Health condition(s) or problem(s) studiedDiabetic eye disease
InterventionThe 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 typeOther
Primary outcome measureSelf-reported visual disability as measured by the Massof Activity Inventory questionnaire at 0, 3 and 6 months
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/04/2009
Completion date30/09/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants100
Key inclusion criteria1. Both males and females
2. Patients with diabetes mellitus attending Moorfields Diabetic Clinics
3. Patients with diabetic eye disease as defined by an ophthalmologist
Key exclusion criteria1. 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
Date of first enrolment01/04/2009
Date of final enrolment30/09/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University College London (UCL) Institute of Ophthalmology
London
EC1V 9EL
United Kingdom

Sponsor information

Moorfields Eye Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Ms Sue Lydeard
Research and Development Department
162 City Road
London
EC1V 2PD
England
United Kingdom

Website http://www.moorfields.nhs.uk
ROR logo "ROR" https://ror.org/03zaddr67

Funders

Funder type

Charity

Fight for Sight (UK) - Clinical Fellowship Grant (ref: 1775/76)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination plan2013 results published in thesis http://discovery.ucl.ac.uk/1393954/
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 01/07/2012 Yes No

Editorial Notes

05/10/2018: Thesis added to publication and dissemination plan.