Implementation of Compliance Improvement for Amblyopia Prevention
| ISRCTN | ISRCTN22835481 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22835481 |
| Protocol serial number | N/A |
| Sponsor | Erasmus Medical Center (The Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (Zon-MW) (The Netherlands) |
- Submission date
- 26/09/2006
- Registration date
- 26/09/2006
- Last edited
- 05/04/2012
- 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 H J Simonsz
Scientific
Scientific
Erasmus Medical Center Rotterdam
Department of Ophthalmology
Room Ba 104
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| Phone | +31 (0)10 408 7275/7276 |
|---|---|
| simonsz@compuserve.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised, paralled armed trial |
| Secondary study design | Non randomised controlled trial |
| Scientific title | Implementation of Compliance Improvement for Amblyopia Prevention: further training course about compliance, an effective information programme and direct referral by child health care centres, primary with orthoptists in foreign and low-SES (socio-economic status) neighbourhoods |
| Study acronym | ICI-AP |
| Study objectives | Orthoptists work more effectually by using an improved compliance enhanced programme and a training course on compliance. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Amblyopia |
| Intervention | At end of year one the orthoptist will receive a three-days training course on compliance with amblyopia prevention. Strategies and techniques to reduce non-compliance are given during the training. All children included in the first year are the control group: receive standard orthoptic care. All children included in the second year is the intervention group: receive the improved educational cartoon story together with a calendar and reward stickers, and a one-page information sheet for the parents. The cartoon is designed as a picture story, without text and is designed from a childs perspective. |
| Intervention type | Other |
| Primary outcome measure(s) |
Whether the orthoptists work is effectual, based on measurements (i.e. questionnaires) at the start of the study, before and after the training course, and at the end of the second year. |
| Key secondary outcome measure(s) |
The electronic occlusion measurements for compliance (actual occlusion time/prescribed occlusion time), the fraction realised Child Health Care centre referrals and the overall acuity improvement will be determined. |
| Completion date | 01/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 6 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Key inclusion criteria | 1. All newly diagnosed children with an inter-ocular difference in visual acuity of more than two logarithm of the Minimum Angle of Resolution (logMAR), strabismus and/or an anisometropia or a deprivation (e.g. cataract) 2. Age: three to six years 3. Both genders 4. Children living in an area with low Socio-Economic Status (SES) in the four big cities of the Netherlands |
| Key exclusion criteria | 1. Children with equal visual acuity between the eyes (less than one logMAR line of difference in visual acuity between eyes) 2. Previous treatment for amblyopia, neurological disorder, medication, other eye disorder or decreased visual acuity caused by brain damage or trauma |
| Date of first enrolment | 01/05/2006 |
| Date of final enrolment | 01/05/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center Rotterdam
Rotterdam
3000 CA
Netherlands
3000 CA
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 | results | 01/12/2010 | Yes | No | |
| Results article | results | 01/12/2011 | Yes | No |
