A randomised controlled trial of treatment of unilateral straight eyed visual acuity deficit
| ISRCTN | ISRCTN06512650 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06512650 |
| Protocol serial number | RRCC7R R1903/6624 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Northern and Yorkshire (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| 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 |
| 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
- United Kingdom
- England
Study participating centre
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom
NE1 4LP
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/01/2005 | Yes | No | ||
| Other publications | 29/11/2003 | Yes | No | ||
| Other publications | 01/08/2004 | Yes | No | ||
| Other publications | 01/07/2006 | Yes | No |
Editorial Notes
09/11/2022: Internal review.
