Electronic Recording of Compliance with Patching Therapy for Amblyopia.

ISRCTN ISRCTN54685764
DOI https://doi.org/10.1186/ISRCTN54685764
Secondary identifying numbers N/A
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
10/06/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr S.E. Loudon
Scientific

Erasmus Medical Center Rotterdam
Department of Ophthalmology
Dr. Molewaterplein 50
Rotterdam
3015 GD
Netherlands

Email seloudon@yahoo.com

Study information

Study designMulticentre, randomised, single blinded, placebo controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleElectronic Recording of Compliance with Patching Therapy for Amblyopia.
Study acronymERPAG
Study objectivesCompliance with patching therapy for amblyopia can be improved by an educational programme aimed primarily at the child.
Ethics approval(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedAmblyopia
InterventionChildren 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 typeOther
Primary outcome measurePercentage of compliance (realised/prescribed occlusion time) in the intervention and control group.
Secondary outcome measuresSecondary outcome measure was influence of social-economic, ethnic and clinical factors on compliance.
Overall study start date01/07/2001
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupChild
SexNot Specified
Target number of participants300
Total final enrolment149
Key inclusion criteria1. 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
Key exclusion criteriaPrevious treatment for amblyopia, neurological disorder, medication, other eye disorder, decreased visual acuity caused by brain damage or trauma
Date of first enrolment01/07/2001
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus Medical Center Rotterdam,
Rotterdam
3015 GD
Netherlands

Sponsor information

Erasmus Medical Center (The Netherlands)
Hospital/treatment centre

Department of Ophthalmology
Dr. Molewaterplein 50
Rotterdam
3015 GD
Netherlands

ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/11/2009 10/06/2021 Yes No

Editorial Notes

10/06/2021: Publication reference and total final enrolment added.