Implementation of Compliance Improvement for Amblyopia Prevention

ISRCTN ISRCTN22835481
DOI https://doi.org/10.1186/ISRCTN22835481
Secondary identifying numbers N/A
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

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
Email simonsz@compuserve.com

Study information

Study designNon-randomised, paralled armed trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleImplementation 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 acronymICI-AP
Study objectivesOrthoptists 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) studiedAmblyopia
InterventionAt 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 child’s perspective.
Intervention typeOther
Primary outcome measureWhether 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.
Secondary outcome measuresThe 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.
Overall study start date01/05/2006
Completion date01/05/2009

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit3 Years
Upper age limit6 Years
SexBoth
Target number of participants300
Key inclusion criteria1. 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 criteria1. 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 enrolment01/05/2006
Date of final enrolment01/05/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus Medical Center Rotterdam
Rotterdam
3000 CA
Netherlands

Sponsor information

Erasmus Medical Center (The Netherlands)
Hospital/treatment centre

P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Website http://www.erasmusmc.nl/content/englishindex.htm
ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (Zon-MW) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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