Electronic Recording of Compliance with Patching Therapy for Amblyopia.
| ISRCTN | ISRCTN54685764 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54685764 |
| Protocol serial number | N/A |
| Sponsor | Erasmus Medical Center (The Netherlands) |
| Funder | The Netherlands Organization for Health Research and Development (ZonMw) (The Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 10/06/2021
- 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 S.E. Loudon
Scientific
Scientific
Erasmus Medical Center Rotterdam
Department of Ophthalmology
Dr. Molewaterplein 50
Rotterdam
3015 GD
Netherlands
| seloudon@yahoo.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, single blinded, placebo controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Electronic Recording of Compliance with Patching Therapy for Amblyopia. |
| Study acronym | ERPAG |
| Study objectives | Compliance with patching therapy for amblyopia can be improved by an educational programme aimed primarily at the child. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Amblyopia |
| Intervention | Children in the intervention group received the educational cartoon story together with a calendar and reward stickers and a one-page information sheet for the parents. The cartoon was designed as a picture story, without text and was designed from a childs perspective. Scientific contact: Prof. H.J. Simonsz, simonsz@compuserve.com. |
| Intervention type | Other |
| Primary outcome measure(s) |
Percentage of compliance (realised/prescribed occlusion time) in the intervention and control group. |
| Key secondary outcome measure(s) |
Secondary outcome measure was influence of social-economic, ethnic and clinical factors on compliance. |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Not Specified |
| Target sample size at registration | 300 |
| Total final enrolment | 149 |
| Key inclusion criteria | 1. All newly diagnosed amblyopic children with an inter-ocular difference in visual acuity of at least 0.2 logMAR, strabismus and/or an anisometropia or a deprivation (e.g. cataract). 2. Both genders 3. No age limitation |
| Key exclusion criteria | Previous treatment for amblyopia, neurological disorder, medication, other eye disorder, decreased visual acuity caused by brain damage or trauma |
| Date of first enrolment | 01/07/2001 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center Rotterdam,
Rotterdam
3015 GD
Netherlands
3015 GD
Netherlands
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 | 01/11/2009 | 10/06/2021 | Yes | No |
Editorial Notes
10/06/2021: Publication reference and total final enrolment added.
