Topic: Eye
Conditions
Interventions
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 0.5 LogMAR in either eye 7. Structural ocular pathology 8. Significant neurodevelopmental delay 9. Families requiring translation services
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients; Timepoint(s): To determine whether participating centres are likely to recruit a sufficient number of patients | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed