Condition category
Eye Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
30/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Additional files

Editorial Notes