Contact information
Type
Scientific
Primary contact
Dr Michael Clarke
ORCID ID
Contact details
Royal Victoria Infirmary
Eye Department
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
+44 (0)191 232 5131
m.p.clarke@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RRCC7R R1903/6624
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
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
Not Specified
Patient information sheet
Condition
Eye diseases
Intervention
The effects of correction of refractive error, alone and in combination with patching will be compared to no treatment.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The main outcome measure at both the preliminary and final analysis will be LogMAR acuity. Anova will be used to test the effect of group and sub-group analyses will test for heterogeneity between and at different initial acuities.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
28/02/1999
Overall trial end date
28/02/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Children aged 3-4 years, with lateral visual acuity defects of 6/9 to 6/24.
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
28/02/1999
Recruitment end date
28/02/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (UK)
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
1. 2003: A randomised controlled trial of treatment of unilateral visual impairment detected at preschool vision screening Clarke M, Wright CM, Hrisos S, Anderson J, Henderson J, Richardson S. BMJ 2003 327:1251-1255 = http://www.ncbi.nlm.nih.gov/pubmed/14644966
2. 2004: The Emotional Impact of Amblyopia Treatment in Preschool Children Hrisos S, Clarke M, Wright CM Ophthalmology 2004 111(8): 1550-1556 = http://www.ncbi.nlm.nih.gov/pubmed/15288987
3. 2005: Stereoacuity in unilateral visual impairment detected at pre school screening: outcomes from a randomised controlled trial S Richardson C.M. Wright S Hrisos D Buck M.P. Clarke Investigative Ophthalmology and Vision Science 2005 46(1) 150-154 = http://www.ncbi.nlm.nih.gov/pubmed/15623768
4. 2006: Unilateral visual impairment and neurodevelopmental performance in preschool children Hrisos S, Clarke MP, Kelly T, Henderson J, Wright CM Br J Ophthalmol 2006;90 836-838 = http://www.ncbi.nlm.nih.gov/pubmed/16540485
Publication citations
-
Clarke MP, Wright CM, Hrisos S, Anderson JD, Henderson J, Richardson SR, Randomised controlled trial of treatment of unilateral visual impairment detected at preschool vision screening., BMJ, 2003, 327, 7426, 1251, doi: 10.1136/bmj.327.7426.1251.
-
Hrisos S, Clarke MP, Wright CM, The emotional impact of amblyopia treatment in preschool children: randomized controlled trial., Ophthalmology, 2004, 111, 8, 1550-1556, doi: 10.1016/j.ophtha.2003.12.059.
-
Richardson SR, Wright CM, Hrisos S, Buck D, Clarke MP, Stereoacuity in unilateral visual impairment detected at preschool screening: outcomes from a randomized controlled trial., Invest. Ophthalmol. Vis. Sci., 2005, 46, 1, 150-154, doi: 10.1167/iovs.04-0672.
-
Hrisos S, Clarke MP, Kelly T, Henderson J, Wright CM, Unilateral visual impairment and neurodevelopmental performance in preschool children., Br J Ophthalmol, 2006, 90, 7, 836-838, doi: 10.1136/bjo.2006.090910.