Condition category
Eye Diseases
Date applied
12/09/2002
Date assigned
12/09/2002
Last edited
08/06/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr CM Dickinson

ORCID ID

Contact details

Department of Optometry and Neuroscience
UMIST
PO Box 88
Manchester
M60 1QD
United Kingdom
+44 (0)161 200 3874
chris.dickinson@umist.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1071/530

Study information

Scientific title

Acronym

Prism Spectacles Study

Study hypothesis

To study prism spectacles in reducing the disability of patients

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Age-related macular degeneration

Intervention

1. Prism spectacles prescribed to established protocol
2. Prism spectacles with prism of standard value
3. Placebo spectacles made to appear like prism spectacles

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2001

Overall trial end date

01/02/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Bilateral ARMD
2. Visual Acuity (VA) 6/18 to 1/60 binocularly
3. Clinically stable (by visual acuity) with bilateral central scotoma
4. Reporting difficulty with everyday tasks

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

225

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/02/2001

Recruitment end date

01/02/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Optometry and Neuroscience
Manchester
M60 1QD
United Kingdom

Sponsor information

Organisation

The Health Foundation (UK)

Sponsor details

90 Long Acre
London
WC2E 9RA
United Kingdom
+44 (0)20 7257 8000
info@health.org.uk

Sponsor type

Charity

Website

http://www.pppfoundation.org.uk/

Funders

Funder type

Charity

Funder name

The Health Foundation (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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16087836

Publication citations

  1. Results

    Smith HJ, Dickinson CM, Cacho I, Reeves BC, Harper RA, A randomized controlled trial to determine the effectiveness of prism spectacles for patients with age-related macular degeneration., Arch. Ophthalmol., 2005, 123, 8, 1042-1050, doi: 10.1001/archopht.123.8.1042.

Additional files

Editorial Notes