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ISRCTN
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ISRCTN05346737
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ClinicalTrials.gov identifier
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Public title
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Can patching be improved in lazy eye treatment?
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Scientific title
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Can patching be improved in amblyopia treatment?
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Educational/ motivational material would improve the compliance with patching treatment.
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Ethics approval
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1. Leicestershire, Northamtonshire & Rutland Research Ethics Committee (LREC). Date or approval: 03/06/2004 (ref: 04/Q2501/32)
2. Multi-centre Research Ethics Committee (MREC). Date of approval: 03/06/2004 (ref: 04/Q2501/32)
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Study design
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Randomised controlled trial.
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Amblyopia
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Participants - inclusion criteria
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1. Children, both males and females, able to perform Glasgow visual acuity test (age 3 - 8 years)
2. Newly detected strabismic, mixed or anisometropic amblyopia (anisometropia = difference >0.5 spherical equivalent or >1.5 diopters for astigmatism) with 0.3 or more logmar difference in visual acuity (VA) between the amblyopic and dominant eye
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Participants - exclusion criteria
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1. Children who have other ophthalmic or neurological diseases
2. Premature children
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Anticipated start date
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02/08/2004
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Anticipated end date
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31/05/2008
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Status of trial
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Completed
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Patient information material
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Target number of participants
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60
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Interventions
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After wearing optimal glasses for 6 weeks children will be asked to patch for all waking hours for 6 out of 7 days a week for 12 weeks.
Group 1: The participants will receive educational materials. We have designed information booklets which explains the condition (amblyopia) for parents, teachers, brothers/sisters and classmates, advice on patching, a motivational story book for the patient and a quotation booklet. We also have a DVD.
Group 2: No intervention
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Primary outcome measure(s)
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Compliance measured by Occlusion Dose Monitor (ODM) for the entire period of patching (3 months).
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Secondary outcome measure(s)
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Difference in percentage increase of VA between Group 1 and 2 at the end of 12 weeks treatment period.
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Sources of funding
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National Eye Research Centre (NERC) (UK)
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Trial website
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Publications
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Contact name
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Prof
Irene
Gottlob
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Address
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University of Leicester
Ophthalmology
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City/town
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Leicester
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Zip/Postcode
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LE2 7LX
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Country
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United Kingdom
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Sponsor
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University Hospitals of Leicester NHS trust (UHL) (UK)
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Address
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Trust Headquarters
Gwendolen House
Gwendolen Road
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City/town
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Leicester
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Zip/Postcode
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LE5 4QF
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Country
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United Kingdom
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Sponsor website:
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http://www.uhl-tr.nhs.uk
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Date applied
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01/04/2008
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Last edited
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16/05/2008
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Date ISRCTN assigned
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16/05/2008
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