Condition category
Eye Diseases
Date applied
22/03/2011
Date assigned
22/03/2011
Last edited
26/05/2015
Prospective/Retrospective
Prospectively 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

Mr M Clarke

ORCID ID

Contact details

Claremont Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
-
m.p.clarke@newcastle.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9967; HTA 09/01/20

Study information

Scientific title

An External Pilot Study to Test the Feasibility of a Randomised Controlled Trial comparing Eye Muscle Surgery against Active Monitoring for Childhood Intermittent Distance Exotropia [X(T)]

Acronym

Pilot RCT comparing Surgery to Observation for Intermittent Exotropia

Study hypothesis

The aim is to design and conduct a randomised controlled trial of the clinical and cost effectiveness of immediate surgical treatment versus active monitoring in the management of intermittent exotropia in children under 16.

More details can be found at http://www.nets.nihr.ac.uk/projects/hta/090120
Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0009/53100/PRO-09-01-20.pdf

Ethics approval

10/H0904/57

Study design

Randomised; Interventional; Design type: Not specified, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Topic: Eye; Subtopic: Eye (all Subtopics); Disease: Ophthalmology

Intervention

Eye muscle surgery

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Number of patients; Timepoint(s): To determine whether participating centres are likely to recruit a sufficient number of patients

Secondary outcome measures

1. Pilot procedures; Timepoint(s): To pilot procedures involved in the trial including recruitment, randomisation, surgery and masking
2. Questionnaires; Timepoint(s): To identify through questionnaires reasons why parents decline permission to participate
3. Recruited patients; Timepoint(s): To determine whether recruited patients remain in allocated groups

Overall trial start date

01/09/2011

Overall trial end date

01/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age = 6 months and = 16 years
2. Diagnosis of Intermittent Exotropia on the basis of parental history and clinical examination within 6 months of recruitment
3. Newcastle Control Score of = 3
4. Minimum size of squint of 15 prism dioptres
5. If aged 4 years and over evidence of near stereopsis i.e. ability to use the eyes together
Target Gender: Male & Female; Upper Age Limit 16 years ; Lower Age Limit 6 months

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 240; UK Sample Size: 144

Participant exclusion criteria

1. Age under 6 months or over 16 years
2. Previous treatment for Intermittent Exotropia
3. Constant exotropia = 10 prism dioptres
4. Constant exotropia < 10 prism dioptres with absent near stereopsis
5. Intermittent Exotropia where near misalignment is = 10 prism dioptres more than the distance misalignment (Convergence insufficiency)
6. blyopia (poor vision) > 0.5 LogMAR in either eye
7. Structural ocular pathology
8. Significant neurodevelopmental delay
9. Families requiring translation services

Recruitment start date

01/09/2011

Recruitment end date

01/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Victoria Infirmary
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Claremont Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

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

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23072556
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26005878

Publication citations

  1. Protocol

    Buck D, McColl E, Powell CJ, Shen J, Sloper J, Steen N, Taylor R, Tiffin P, Vale L, Clarke MP, Surgery versus Active Monitoring in Intermittent Exotropia (SamExo): study protocol for a pilot randomised controlled trial., Trials, 2012, 13, 192, doi: 10.1186/1745-6215-13-192.

  2. Results

    Clarke M, Hogan V, Buck D, Shen J, Powell C, Speed C, Tiffin P, Sloper J, Taylor R, Nassar M, Joyce K, Beyer F, Thomson R, Vale L, McColl E, Steen N, An external pilot study to test the feasibility of a randomised controlled trial comparing eye muscle surgery against active monitoring for childhood intermittent exotropia [X(T)], Health Technol Assess, 2015 , 19, 39, 1-144.

Additional files

Editorial Notes