Condition category
Eye Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
05/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anna Horwood

ORCID ID

Contact details

Department of Orthoptics
Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom
+44 (0)118 322 7683
a.m.horwood@reading.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0199157881

Study information

Scientific title

Acronym

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

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Eye Diseases: Hypermetropia

Intervention

Trial status amended to 'stopped' as of 05/04/2013 due to notification of lack of funding.

Initial undercorrection vs full correction

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Time to optimum acuity, change in refractive error, compliance & acceptance of glasses, achievement of normal vision at one year.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

12/03/2005

Overall trial end date

31/12/2010

Reason abandoned

Lack of funding/sponsorship

Eligibility

Participant inclusion criteria

Opportunistic sample of children aged between 3.5 and 6 years with simple hypermetropia and/or astigmatism as their only ocular diagnosis

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

Target 40 subjects assigned to 'Full Correction' group and 40 subjects assigned to 'Undercorrection' group.

Participant exclusion criteria

Manifest strabismus excluding non-accommodative microtropia and extropia, amblyopia which needs occlusion treatment.

Recruitment start date

12/03/2005

Recruitment end date

31/12/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Orthoptics
Reading
RG1 5AN
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

Royal Berkshire and Battle Hospitals NHS Trust (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

Publication citations

Additional files

Editorial Notes