Condition category
Eye Diseases
Date applied
16/05/2006
Date assigned
28/06/2006
Last edited
30/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.moorfieldsresearch.org.uk/process

Contact information

Type

Scientific

Primary contact

Prof Michael Crossland

ORCID ID

Contact details

Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CROM1005

Study information

Scientific title

Acronym

ModLow

Study hypothesis

Consultation with a trained low vision support worker (in addition to a standard low vision clinic appointment) will improve patients' self-reported vision related quality of life.

Ethics approval

Ethics approval received from the Moorfields Eye Hospital ethics committee (ref: CROM1005).

Study design

Prospective, randomised, single-blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

Visual impairment

Intervention

Arm one (intervention): a further one-hour appointment with a trained low vision support worker, to review the use of low vision devices, access to local services, aspects of daily living and to become a named contact for patients

Arm two (control): a one-hour well-person check with a nurse comprising height measurement, weight measurement, blood pressure measurement, lifestyle advice and health advice

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Vision related task difficulty, as assessed using the Activity Inventory scale (AI), a rigorous validated quality-of-life instrument administered as a telephone questionnaire.

Secondary outcome measures

Vision related task importance (also assessed on the AI).

Overall trial start date

01/01/2006

Overall trial end date

30/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with visual impairment referred into the low vision clinic at the St George's outreach clinic, Moorfields Eye Hospital, Visual impairment can be classed as:
1. Age-related macular disease
2. Glaucoma
3. Cataract
4. Retinitis pigmentosa
5. Juvenile macular diseases
6. Optic neuritis
7. Other causes of visual impairment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant exclusion criteria

1. Those living in residential care homes
2. Those with good vision inappropriately referred to the low vision clinic
3. Those unable to perform a telephone-based interview

Recruitment start date

01/01/2006

Recruitment end date

30/06/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom

Sponsor information

Organisation

Moorfields Eye Hospital (UK)

Sponsor details

City Road
London
EC1V 2PD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.moorfields.nhs.uk

Funders

Funder type

Charity

Funder name

Special Trustees of Moorfields Eye Hospital (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. 2011 Results in http://www.ncbi.nlm.nih.gov/pubmed/20837788

Publication citations

  1. Results

    Pearce E, Crossland MD, Rubin GS, The efficacy of low vision device training in a hospital-based low vision clinic., Br J Ophthalmol, 2011, 95, 1, 105-108, doi: 10.1136/bjo.2009.175703.

Additional files

Editorial Notes