A randomised controlled trial of the effectiveness of prism spectacles in reducing the disability of patients with age-related macular degeneration (ARMD)
| ISRCTN | ISRCTN00821605 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00821605 |
| Protocol serial number | 1071/530 |
| Sponsor | The Health Foundation (UK) |
| Funder | The Health Foundation (UK) |
- Submission date
- 12/09/2002
- Registration date
- 12/09/2002
- Last edited
- 08/06/2011
- 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 CM Dickinson
Scientific
Scientific
Department of Optometry and Neuroscience
UMIST
PO Box 88
Manchester
M60 1QD
United Kingdom
| Phone | +44 (0)161 200 3874 |
|---|---|
| chris.dickinson@umist.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Prism Spectacles Study |
| Study objectives | To study prism spectacles in reducing the disability of patients |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/02/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 225 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/02/2001 |
| Date of final enrolment | 01/02/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Optometry and Neuroscience
Manchester
M60 1QD
United Kingdom
M60 1QD
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 | 01/08/2005 | Yes | No |
