Improvement in focus during treatment of amblyopia
| ISRCTN | ISRCTN04238743 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04238743 |
| Secondary identifying numbers | N0280149492 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 07/04/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs P M Pennefather
Scientific
Scientific
Consultant Ophthalmologist
Wirral Hospital NHS Trust
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom
| Phone | +44 (0)151 678 5111 ext 2705 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Is it possible to improve focus as well as vision during treatment of amblyopia? To identify any effect on efficiency of patching to improve vision. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Eye Diseases: Amblyopia |
| Intervention | Group 1 = patching treatment with glasses Group 2 = patching treatment without glasses |
| Intervention type | Other |
| Primary outcome measure | Measure of the focus (refractive error) at 2, 5 and 11 months. |
| Secondary outcome measures | Visual acuity assessment monthly during patching treatment. |
| Overall study start date | 15/03/2004 |
| Completion date | 14/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | Sample: 180 in total |
| Key inclusion criteria | Children with low to moderate hypermetropia and strabismus requiring patching treatment for amblyopia |
| Key exclusion criteria | 1. Anisometropia without strabismus 2. Vision better than 6/18 in the amblyopic eye 3. Anisometropia of less than .5 diopter 4. Child more than 5 years of age 5. Astigmatism of greater than 1.5 diopters 6. Ocular co-morbidity |
| Date of first enrolment | 15/03/2004 |
| Date of final enrolment | 14/03/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Consultant Ophthalmologist
Wirral
CH49 5PE
United Kingdom
CH49 5PE
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Wirral Hospitals NHS Trust (UK), NHS Research and Development Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
