Can patching be improved in lazy eye treatment?
| ISRCTN | ISRCTN05346737 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05346737 |
| Protocol serial number | N/A |
| Sponsor | University Hospitals of Leicester NHS trust (UHL) (UK) |
| Funder | National Eye Research Centre (NERC) (UK) |
- Submission date
- 01/04/2008
- Registration date
- 16/05/2008
- Last edited
- 17/03/2014
- 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
Prof Irene Gottlob
Scientific
Scientific
University of Leicester
Ophthalmology
Leicester
LE2 7LX
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Can patching be improved in amblyopia treatment? |
| Study objectives | Educational/motivational material would improve the compliance with patching treatment. As of 30/11/2011 the anticipated end date for this trial has been updated. The original date was 31/05/2008. |
| Ethics approval(s) | 1. Leicestershire, Northamtonshire & Rutland Research Ethics Committee (LREC), 03/06/2004, ref: 04/Q2501/32 2. Multi-centre Research Ethics Committee (MREC), 03/06/2004, ref: 04/Q2501/32 |
| Health condition(s) or problem(s) studied | Amblyopia |
| Intervention | After wearing optimal glasses for 6 weeks children will be asked to patch for all waking hours for 6 out of 7 days a week for 12 weeks. Group 1: The participants will receive educational materials. We have designed information booklets which explains the condition (amblyopia) for parents, teachers, brothers/sisters and classmates, advice on patching, a motivational story book for the patient and a quotation booklet. We also have a DVD. Group 2: No intervention Update as of 30/11/2011: An amendment was made to also include mointoring of glasses wear. |
| Intervention type | Other |
| Primary outcome measure(s) |
Compliance measured by Occlusion Dose Monitor (ODM) for the entire period of patching (3 months). |
| Key secondary outcome measure(s) |
Difference in percentage increase of VA between Group 1 and 2 at the end of 12 weeks treatment period. |
| Completion date | 31/05/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 8 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Children, both males and females, able to perform Glasgow visual acuity test (age 3 - 8 years) 2. Newly detected strabismic, mixed or anisometropic amblyopia (anisometropia = difference >0.5 spherical equivalent or >1.5 diopters for astigmatism) with 0.3 or more logmar difference in visual acuity (VA) between the amblyopic and dominant eye |
| Key exclusion criteria | 1. Children who have other ophthalmic or neurological diseases 2. Premature children |
| Date of first enrolment | 02/08/2004 |
| Date of final enrolment | 31/05/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Leicester
Leicester
LE2 7LX
United Kingdom
LE2 7LX
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? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2014 | Yes | No |
