|
ISRCTN
|
ISRCTN12271374
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
RCT to assess effects of undercorrection or full correction of hypermetropic & astigmatic refractive errors in children on time to optimum acuity, change in refractive error, compliance & acceptance of glasses & achievement of normal vision at 1 year
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0199157881
|
|
Study hypothesis
|
To assess effects of initial undercorrection or full correction of hypermetropic & astigmatic refractive errors in children on time to optimum acuity, change in refractive error, compliance & acceptance of glasses & achievement of normal vision at 1 year
|
|
Lay summary
|
|
|
Ethics approval
|
Added 05/09/08: Berkshire Research Ethics Committee (UK) ref 05/Q1602/21, 11/03/ 2005, approval renewed 2/.08/08.
|
|
Study design
|
Double masked randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Eye Diseases: Hypermetropia
|
|
Participants - inclusion criteria
|
Opportunistic sample of children aged between 3.5 and 6 years with simple hypermetropia and/or astigmatism as their only ocular diagnosis
|
|
Participants - exclusion criteria
|
Manifest strabismus excluding non-accommodative microtropia and extropia, amblyopia which needs occlusion treatment.
|
|
Anticipated start date
|
12/03/2005
|
|
Anticipated end date
|
31/12/2010
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
Target 40 subjects assigned to 'Full Correction' group and 40 subjects assigned to 'Undercorrection' group.
|
|
Interventions
|
Initial undercorrection vs full correction
|
|
Primary outcome measure(s)
|
Time to optimum acuity, change in refractive error, compliance & acceptance of glasses, achievement of normal vision at one year.
|
|
Secondary outcome measure(s)
|
No secondary outcome measures
|
|
Sources of funding
|
Royal Berkshire and Battle Hospitals NHS Trust (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Anna
Horwood
|
|
Address
|
Department of Orthoptics
Royal Berkshire Hospital
London Road
|
|
City/town
|
Reading
|
|
Zip/Postcode
|
RG1 5AN
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)118 322 7683
|
|
Fax
|
+44 (0)118 987 7685
|
|
Email
|
a.m.horwood@reading.ac.uk
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
|
|
Address
|
The Department of Health
Richmond House
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Fax
|
+44 (0)20 7307 2623
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
30/09/2005
|
|
Last edited
|
05/09/2008
|
|
Date ISRCTN assigned
|
30/09/2005
|
