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 |
| Secondary identifying numbers | N0199157881 |
- 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
| Study design | Double masked randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | Time to optimum acuity, change in refractive error, compliance & acceptance of glasses, achievement of normal vision at one year. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 12/03/2005 |
| 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 number of participants | Target 40 subjects assigned to 'Full Correction' group and 40 subjects assigned to 'Undercorrection' group. |
| 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
- England
- United Kingdom
Study participating centre
Department of Orthoptics
Reading
RG1 5AN
United Kingdom
RG1 5AN
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
Royal Berkshire and Battle Hospitals NHS Trust (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 |
