Condition category
Eye Diseases
Date applied
26/09/2006
Date assigned
26/09/2006
Last edited
05/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 child’s perspective.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

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

http://www.erasmusmc.nl/content/englishindex.htm

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes