Condition category
Eye Diseases
Date applied
10/02/2009
Date assigned
16/02/2009
Last edited
29/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gary Rubin

ORCID ID

Contact details

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

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 measures

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

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

http://www.moorfields.nhs.uk

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22620493

Publication citations

  1. 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.

Additional files

Editorial Notes