Randomised Controlled Trial of Low Vision Rehabilitation Services.

ISRCTN	ISRCTN08985063
DOI	https://doi.org/10.1186/ISRCTN08985063
Protocol serial number	RHC18039
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive North West (UK)

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 15/12/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Robert Harper
Scientific

Central Manchester Healthcare NHS Trust
Manchester Royal Eye Hospital
Oxford Road
Manchester
M13 9WH
United Kingdom

Phone	+44 (0)161 276 5508
Email	robert.harper@man.ac.uk

Study information

Primary study design	Interventional
Study design	Three-arm randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/10/2001

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	225
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/06/1997
Date of final enrolment	01/10/2001

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Central Manchester Healthcare NHS Trust

Manchester
M13 9WH
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?
Results article	results	01/11/2004		Yes	No
Protocol article	protocol	01/01/2001		Yes	No