Condition category
Eye Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
07/04/2014
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

Mrs P M Pennefather

ORCID ID

Contact details

Consultant Ophthalmologist
Wirral Hospital NHS Trust
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom
+44 (0)151 678 5111 ext 2705

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes