Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Can patching be improved in amblyopia treatment?
Acronym
Study hypothesis
Educational/motivational material would improve the compliance with patching treatment.
As of 30/11/2011 the anticipated end date for this trial has been updated. The original date was 31/05/2008.
Ethics approval
1. Leicestershire, Northamtonshire & Rutland Research Ethics Committee (LREC), 03/06/2004, ref: 04/Q2501/32
2. Multi-centre Research Ethics Committee (MREC), 03/06/2004, ref: 04/Q2501/32
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Amblyopia
Intervention
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
Update as of 30/11/2011: An amendment was made to also include mointoring of glasses wear.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Compliance measured by Occlusion Dose Monitor (ODM) for the entire period of patching (3 months).
Secondary outcome measures
Difference in percentage increase of VA between Group 1 and 2 at the end of 12 weeks treatment period.
Overall trial start date
02/08/2004
Overall trial end date
31/05/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Children who have other ophthalmic or neurological diseases
2. Premature children
Recruitment start date
02/08/2004
Recruitment end date
31/05/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Leicester
Leicester
LE2 7LX
United Kingdom
Sponsor information
Organisation
University Hospitals of Leicester NHS trust (UHL) (UK)
Sponsor details
Trust Headquarters
Gwendolen House
Gwendolen Road
Leicester
LE5 4QF
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
National Eye Research Centre (NERC) (UK)
Alternative name(s)
NERC
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
United Kingdom
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
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24615684
Publication citations
-
Results
Pradeep A, Proudlock FA, Awan M, Bush G, Collier J, Gottlob I, An educational intervention to improve adherence to high-dosage patching regimen for amblyopia: a randomised controlled trial., Br J Ophthalmol, 2014, 98, 7, 865-870, doi: 10.1136/bjophthalmol-2013-304187.