Condition category
Eye Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
15/12/2009
Prospective/Retrospective
Retrospectively 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

Dr Robert Harper

ORCID ID

Contact details

Central Manchester Healthcare NHS Trust
Manchester Royal Eye Hospital
Oxford Road
Manchester
M13 9WH
United Kingdom
+44 (0)161 276 5508
robert.harper@man.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RHC18039

Study information

Scientific title

Acronym

Study hypothesis

The proposed study is a 3-arm randomised controlled trial, comparing the effectiveness of a conventional hospital based optometric low vision service and an integrated low vision service for patients with age related macular degeneration (ARMD).

Ethics approval

Not provided at time of registration

Study design

Three-arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Eye diseases: age-related macular degeneration

Intervention

Plan of Investigation
ARM 1 : Patients will receive conventional optometric low vision care in Hospital Eye Service.
ARM 2 : Patients will receive integrated low vision care. In addition to conventional optometric management, these patients will be seen three times by a trained low vision rehabilitation officer. The officer will give specific rehabilitation training.
ARM 3 : Patients in arm 3 will receive conventional optometric management and will be seen three times by a community care worker - specific rehabilitation training will not be given by the community care worker (age concern).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Primary outcome measures include:
Low vision specific and generic health status questionnaires, and measures of vional function.
In addition, the study aims to estimate and compare the costs of these models of low vision care.
Main study outcomes include :
Visual Functions - near and distance logMAR visual acuity, contrast sensitivity, reading speed.
Low vision symptoms - MREH low vision questionnaire.
Quality of Life - SF36 questionnaire, Nottingham Adjustment Scale.
Health and Welfare Service usage - including hospital visits, contacts with GP's, other members of the Primary Care Team, Social Services and voluntary organisations.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/1997

Overall trial end date

01/10/2001

Reason abandoned

Eligibility

Participant inclusion criteria

We propose to recruit 225 new patients (75 in each group) on the basis of a recent audit of the low vision service at MREH.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

225

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/1997

Recruitment end date

01/10/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Central Manchester Healthcare NHS Trust
Manchester
M13 9WH
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive North West (UK)

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

1. 2001 protocol on http://www.ncbi.nlm.nih.gov/pubmed/11220039
2. 2004 results on http://www.ncbi.nlm.nih.gov/pubmed/15489491

Publication citations

  1. Protocol

    Russell W, Harper R, Reeves B, Waterman H, Henson D, McLeod D, Randomised controlled trial of an integrated versus an optometric low vision rehabilitation service for patients with age-related macular degeneration: study design and methodology., Ophthalmic Physiol Opt, 2001, 21, 1, 36-44.

  2. Results

    Reeves BC, Harper RA, Russell WB, Enhanced low vision rehabilitation for people with age related macular degeneration: a randomised controlled trial., Br J Ophthalmol, 2004, 88, 11, 1443-1449, doi: 10.1136/bjo.2003.037457.

Additional files

Editorial Notes