|- candidate number||1522|
|- NTR Number||NTR322|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||9-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Electronic Recording of Compliance with Patching Therapy for Amblyopia.|
|- Scientific Title||Electronic Recording of Compliance with Patching Therapy for Amblyopia: (1) Effects of Patient Education on Compliance; (2) Predictors for Non-Compliance.|
|- hypothesis||Compliance with patching therapy for amblyopia can be improved by an educational programme aimed primarily at the child.|
|- Healt Condition(s) or Problem(s) studied||Amblyopia|
|- 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.
|- Exclusion criteria||1. Previous treatment for amblyopia;|
2. neurological disorder;
4. other eye disorder;
5. decreased visual acuity caused by brain damage or trauma.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2001|
|- planned closingdate||31-dec-2005|
|- Target number of participants||300|
|- Interventions||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.|
|- Primary outcome||Percentage of compliance (realised/prescribed occlusion time) in the intervention and control group.
|- Secondary outcome||Secondary outcome measure was influence of social-economic, ethnic and clinical factors on compliance.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| S.E. Loudon|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. H.J. Simonsz|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Ophthalmology|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Publications||1. 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 summary||N/A|
|- Main changes (audit trail)|
|- RECORD||9-sep-2005 - 9-okt-2008|