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Electronic Recording of Compliance with Patching Therapy for Amblyopia.


- candidate number1522
- NTR NumberNTR322
- ISRCTNISRCTN54685764
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-sep-2005
- Secondary IDsN/A 
- Public TitleElectronic Recording of Compliance with Patching Therapy for Amblyopia.
- Scientific TitleElectronic Recording of Compliance with Patching Therapy for Amblyopia: (1) Effects of Patient Education on Compliance; (2) Predictors for Non-Compliance.
- ACRONYMERPAG
- hypothesisCompliance with patching therapy for amblyopia can be improved by an educational programme aimed primarily at the child.
- Healt Condition(s) or Problem(s) studiedAmblyopia
- 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.
- Exclusion criteria1. Previous treatment for amblyopia;
2. neurological disorder;
3. medication;
4. other eye disorder;
5. decreased visual acuity caused by brain damage or trauma.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2001
- planned closingdate31-dec-2005
- Target number of participants300
- InterventionsChildren 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.
- Primary outcomePercentage of compliance (realised/prescribed occlusion time) in the intervention and control group.
- Secondary outcomeSecondary outcome measure was influence of social-economic, ethnic and clinical factors on compliance.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES S.E. Loudon
- CONTACT for SCIENTIFIC QUERIESProf. Dr. H.J. Simonsz
- Sponsor/Initiator Erasmus Medical Center, Department of Ophthalmology
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications1. Loudon SE, Polling JR, Simonsz HJ. Electronically measured compliance with occlusion therapy for amblyopia is related to visual acuity increase. Graefes Arch Clin Exp Ophthalmol. 2003 Mar;241(3):176-80.
2. Chopovska Y, Loudon SE, Cirina L, Zubcov A, Simonsz HJ, Luchtenberg M, Fronius M. Electronic recording of occlusion treatment for amblyopia: potential of the new technology.
3. Loudon SE, Simonsz HJ The history of the treatment of amblyopia.
- Brief summaryN/A
- Main changes (audit trail)
- RECORD9-sep-2005 - 9-okt-2008


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