Condition category
Eye Diseases
Date applied
01/04/2008
Date assigned
16/05/2008
Last edited
17/03/2014
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

Prof Irene Gottlob

ORCID ID

Contact details

University of Leicester
Ophthalmology
Leicester
LE2 7LX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Can patching be improved in amblyopia treatment?

Acronym

Study hypothesis

Educational/motivational material would improve the compliance with patching treatment.

As of 30/11/2011 the anticipated end date for this trial has been updated. The original date was 31/05/2008.

Ethics approval

1. Leicestershire, Northamtonshire & Rutland Research Ethics Committee (LREC), 03/06/2004, ref: 04/Q2501/32
2. Multi-centre Research Ethics Committee (MREC), 03/06/2004, ref: 04/Q2501/32

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Amblyopia

Intervention

After wearing optimal glasses for 6 weeks children will be asked to patch for all waking hours for 6 out of 7 days a week for 12 weeks.

Group 1: The participants will receive educational materials. We have designed information booklets which explains the condition (amblyopia) for parents, teachers, brothers/sisters and classmates, advice on patching, a motivational story book for the patient and a quotation booklet. We also have a DVD.
Group 2: No intervention

Update as of 30/11/2011: An amendment was made to also include mointoring of glasses wear.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Compliance measured by Occlusion Dose Monitor (ODM) for the entire period of patching (3 months).

Secondary outcome measures

Difference in percentage increase of VA between Group 1 and 2 at the end of 12 weeks treatment period.

Overall trial start date

02/08/2004

Overall trial end date

31/05/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children, both males and females, able to perform Glasgow visual acuity test (age 3 - 8 years)
2. Newly detected strabismic, mixed or anisometropic amblyopia (anisometropia = difference >0.5 spherical equivalent or >1.5 diopters for astigmatism) with 0.3 or more logmar difference in visual acuity (VA) between the amblyopic and dominant eye

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Children who have other ophthalmic or neurological diseases
2. Premature children

Recruitment start date

02/08/2004

Recruitment end date

31/05/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leicester
Leicester
LE2 7LX
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS trust (UHL) (UK)

Sponsor details

Trust Headquarters
Gwendolen House
Gwendolen Road
Leicester
LE5 4QF
United Kingdom

Sponsor type

Government

Website

http://www.uhl-tr.nhs.uk

Funders

Funder type

Charity

Funder name

National Eye Research Centre (NERC) (UK)

Alternative name(s)

NERC

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24615684

Publication citations

  1. Results

    Pradeep A, Proudlock FA, Awan M, Bush G, Collier J, Gottlob I, An educational intervention to improve adherence to high-dosage patching regimen for amblyopia: a randomised controlled trial., Br J Ophthalmol, 2014, 98, 7, 865-870, doi: 10.1136/bjophthalmol-2013-304187.

Additional files

Editorial Notes