Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0280149492
Study information
Scientific title
Acronym
Study hypothesis
Is it possible to improve focus as well as vision during treatment of amblyopia? To identify any effect on efficiency of patching to improve vision.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Eye Diseases: Amblyopia
Intervention
Group 1 = patching treatment with glasses
Group 2 = patching treatment without glasses
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Measure of the focus (refractive error) at 2, 5 and 11 months.
Secondary outcome measures
Visual acuity assessment monthly during patching treatment.
Overall trial start date
15/03/2004
Overall trial end date
14/03/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Children with low to moderate hypermetropia and strabismus requiring patching treatment for amblyopia
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Sample: 180 in total
Participant exclusion criteria
1. Anisometropia without strabismus
2. Vision better than 6/18 in the amblyopic eye
3. Anisometropia of less than .5 diopter
4. Child more than 5 years of age
5. Astigmatism of greater than 1.5 diopters
6. Ocular co-morbidity
Recruitment start date
15/03/2004
Recruitment end date
14/03/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Consultant Ophthalmologist
Wirral
CH49 5PE
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Wirral Hospitals NHS Trust (UK), NHS Research and Development Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Results - basic reporting
Publication summary