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ISRCTN
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ISRCTN22835481
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ClinicalTrials.gov identifier
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Public title
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Implementation of Compliance Improvement for Amblyopia Prevention
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Scientific title
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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
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Acronym
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ICI-AP
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Serial number at source
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N/A
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Study hypothesis
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Orthoptists work more effectually by using an improved compliance enhanced programme and a training course on compliance.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Ethics approval received from the local medical ethics committee
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Study design
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Non-randomised, paralled armed trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Amblyopia
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/05/2006
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Anticipated end date
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01/05/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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300
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Interventions
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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 child’s perspective.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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The Netherlands Organisation for Health Research and Development (Zon-MW) (The Netherlands)
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Trial website
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Publications
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1. 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/21091336
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21399941
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Contact name
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Dr
H J
Simonsz
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Address
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Erasmus Medical Center Rotterdam
Department of Ophthalmology
Room Ba 104
P.O. Box 2040
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City/town
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Rotterdam
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Zip/Postcode
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3000 CA
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Country
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Netherlands
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Tel
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+31 (0)10 408 7275/7276
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Email
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simonsz@compuserve.com
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Sponsor
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Erasmus Medical Center (The Netherlands)
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Address
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P.O. Box 2040
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City/town
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Rotterdam
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Zip/Postcode
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3000 CA
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Country
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Netherlands
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Sponsor website:
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http://www.erasmusmc.nl/content/englishindex.htm
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Date applied
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26/09/2006
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Last edited
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05/04/2012
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Date ISRCTN assigned
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26/09/2006
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