ISRCTN ISRCTN05346737
DOI https://doi.org/10.1186/ISRCTN05346737
Secondary identifying numbers N/A
Submission date
01/04/2008
Registration date
16/05/2008
Last edited
17/03/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Irene Gottlob
Scientific

University of Leicester
Ophthalmology
Leicester
LE2 7LX
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleCan patching be improved in amblyopia treatment?
Study objectivesEducational/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(s)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
Health condition(s) or problem(s) studiedAmblyopia
InterventionAfter 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 typeOther
Primary outcome measureCompliance measured by Occlusion Dose Monitor (ODM) for the entire period of patching (3 months).
Secondary outcome measuresDifference in percentage increase of VA between Group 1 and 2 at the end of 12 weeks treatment period.
Overall study start date02/08/2004
Completion date31/05/2012

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit3 Years
Upper age limit8 Years
SexBoth
Target number of participants60
Key inclusion criteria1. 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
Key exclusion criteria1. Children who have other ophthalmic or neurological diseases
2. Premature children
Date of first enrolment02/08/2004
Date of final enrolment31/05/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Leicester
Leicester
LE2 7LX
United Kingdom

Sponsor information

University Hospitals of Leicester NHS trust (UHL) (UK)
Hospital/treatment centre

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

Website http://www.uhl-tr.nhs.uk
ROR logo "ROR" https://ror.org/02fha3693

Funders

Funder type

Charity

National Eye Research Centre (NERC) (UK)
Private sector organisation / Universities (academic only)
Alternative name(s)
National Eye Research Centre, SightResearchUK, SRUK, NERC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2014 Yes No