Contact information
Type
Scientific
Primary contact
Dr H J Simonsz
ORCID ID
Contact details
Erasmus Medical Center Rotterdam
Department of Ophthalmology
Room Ba 104
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 408 7275/7276
simonsz@compuserve.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
ICI-AP
Study hypothesis
Orthoptists work more effectually by using an improved compliance enhanced programme and a training course on compliance.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Non-randomised, paralled armed trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
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.
Secondary outcome measures
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.
Overall trial start date
01/05/2006
Overall trial end date
01/05/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
300
Participant 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
Recruitment start date
01/05/2006
Recruitment end date
01/05/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center Rotterdam
Rotterdam
3000 CA
Netherlands
Sponsor information
Organisation
Erasmus Medical Center (The Netherlands)
Sponsor details
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (Zon-MW) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/21091336
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21399941
Publication citations
-
Results
Tjiam AM, Vukovic E, Asjes-Tydeman WL, Holtslag G, Loudon SE, Sinoo MM, Simonsz HJ, How Dutch orthoptists deal with noncompliance with occlusion therapy for amblyopia., Strabismus, 2010, 18, 4, 146-166, doi: 10.3109/09273972.2010.529983.
-
Results
Tjiam AM, Akcan H, Ziylan F, Vukovic E, Loudon SE, Looman CW, Passchier J, Simonsz HJ, Sociocultural and psychological determinants in migrants for noncompliance with occlusion therapy for amblyopia., Graefes Arch. Clin. Exp. Ophthalmol., 2011, 249, 12, 1893-1899, doi: 10.1007/s00417-011-1637-5.