A randomised controlled trial of treatment of unilateral straight eyed visual acuity deficit
| ISRCTN | ISRCTN06512650 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06512650 |
| Secondary identifying numbers | RRCC7R R1903/6624 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 09/11/2022
- 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 Michael Clarke
Scientific
Scientific
Royal Victoria Infirmary
Eye Department
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
| Phone | +44 (0)191 232 5131 |
|---|---|
| m.p.clarke@ncl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | A randomised controlled trial of treatment of unilateral straight eyed visual acuity deficit |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Eye diseases |
| Intervention | The effects of correction of refractive error, alone and in combination with patching will be compared to no treatment. |
| Intervention type | Other |
| Primary outcome measure | The main outcome measure at both the preliminary and final analysis will be LogMAR acuity. Anova will be used to test the effect of group and sub-group analyses will test for heterogeneity between and at different initial acuities. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 28/02/1999 |
| Completion date | 28/02/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 4 Years |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Children aged 3-4 years, with lateral visual acuity defects of 6/9 to 6/24. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 28/02/1999 |
| Date of final enrolment | 28/02/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom
NE1 4LP
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (UK)
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | 29/11/2003 | Yes | No | ||
| Other publications | 01/08/2004 | Yes | No | ||
| Results article | 01/01/2005 | Yes | No | ||
| Other publications | 01/07/2006 | Yes | No |
Editorial Notes
09/11/2022: Internal review.
