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 childs 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
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