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 |
| Protocol serial number | 08/H0716/70 |
| Sponsor | Moorfields Eye Hospital NHS Foundation Trust (UK) |
| Funder | Fight for Sight (UK) - Clinical Fellowship Grant (ref: 1775/76) |
- 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
Scientific
University College London (UCL) Institute of Ophthalmology
Department of Visual Neuroscience
11-43 Bath Street
London
EC1V 9EL
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised delayed-intervention controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effect of low vision rehabilitation on self-reported visual disability for people with diabetic eye disease: a randomised controlled trial. |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
Self-reported visual disability as measured by the Massof Activity Inventory questionnaire at 0, 3 and 6 months |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2009 |
| Date of final enrolment | 30/09/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University College London (UCL) Institute of Ophthalmology
London
EC1V 9EL
United Kingdom
EC1V 9EL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/07/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/10/2018: Thesis added to publication and dissemination plan.
