Condition category
Eye Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
09/11/2007
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 S.E. Loudon

ORCID ID

Contact details

Erasmus Medical Center Rotterdam
Department of Ophthalmology
Dr. Molewaterplein 50
Rotterdam
3015 GD
Netherlands
seloudon@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

ERPAG

Study hypothesis

Compliance with patching therapy for amblyopia can be improved by an educational programme aimed primarily at the child.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, single blinded, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Amblyopia

Intervention

Children in the intervention group received the educational cartoon story together with a calendar and reward stickers and a one-page information sheet for the parents. The cartoon was designed as a picture story, without text and was designed from a child’s perspective.

Scientific contact: Prof. H.J. Simonsz, simonsz@compuserve.com.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Percentage of compliance (realised/prescribed occlusion time) in the intervention and control group.

Secondary outcome measures

Secondary outcome measure was influence of social-economic, ethnic and clinical factors on compliance.

Overall trial start date

01/07/2001

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. All newly diagnosed amblyopic children with an inter-ocular difference in visual acuity of at least 0.2 logMAR, strabismus and/or an anisometropia or a deprivation (e.g. cataract).
2. Both genders
3. No age limitation

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

300

Participant exclusion criteria

Previous treatment for amblyopia, neurological disorder, medication, other eye disorder, decreased visual acuity caused by brain damage or trauma

Recruitment start date

01/07/2001

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center Rotterdam,
Rotterdam
3015 GD
Netherlands

Sponsor information

Organisation

Erasmus Medical Center (The Netherlands)

Sponsor details

Department of Ophthalmology
Dr. Molewaterplein 50
Rotterdam
3015 GD
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

The Netherlands Organization for Health Research and Development (ZonMw) (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

Publication citations

Additional files

Editorial Notes