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)]

Completed

• Conditions: Topic: Eye; Subtopic: Eye (all Subtopics); Disease: Ophthalmology; Eye Diseases; Childhood Intermittent Distance Exotropia

• Registration Number: ISRCTN44114892
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-22
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 144

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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