RCT to assess effects of undercorrection or full correction of hypermetropic & astigmatic refractive errors in children on time to optimum acuity, change in refractive error, compliance & acceptance of glasses & achievement of normal vision at 1 year
| ISRCTN | ISRCTN12271374 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12271374 |
| Protocol serial number | N0199157881 |
| Sponsor | Department of Health |
| Funder | Royal Berkshire and Battle Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 05/04/2013
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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
Dr Anna Horwood
Scientific
Scientific
Department of Orthoptics
Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom
| Phone | +44 (0)118 322 7683 |
|---|---|
| a.m.horwood@reading.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double masked randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | To assess effects of initial undercorrection or full correction of hypermetropic & astigmatic refractive errors in children on time to optimum acuity, change in refractive error, compliance & acceptance of glasses & achievement of normal vision at 1 year |
| Ethics approval(s) | Added 05/09/08: Berkshire Research Ethics Committee (UK) ref 05/Q1602/21, 11/03/ 2005, approval renewed 2/.08/08. |
| Health condition(s) or problem(s) studied | Eye Diseases: Hypermetropia |
| Intervention | Trial status amended to 'stopped' as of 05/04/2013 due to notification of lack of funding. Initial undercorrection vs full correction |
| Intervention type | Other |
| Primary outcome measure(s) |
Time to optimum acuity, change in refractive error, compliance & acceptance of glasses, achievement of normal vision at one year. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/12/2010 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3.5 Years |
| Upper age limit | 6 Years |
| Sex | Not Specified |
| Target sample size at registration | 80 |
| Key inclusion criteria | Opportunistic sample of children aged between 3.5 and 6 years with simple hypermetropia and/or astigmatism as their only ocular diagnosis |
| Key exclusion criteria | Manifest strabismus excluding non-accommodative microtropia and extropia, amblyopia which needs occlusion treatment. |
| Date of first enrolment | 12/03/2005 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Orthoptics
Reading
RG1 5AN
United Kingdom
RG1 5AN
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
