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)]
| ISRCTN | ISRCTN44114892 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44114892 |
| Protocol serial number | 9967; HTA 09/01/20 |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation Trust (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) |
- Submission date
- 22/03/2011
- Registration date
- 22/03/2011
- Last edited
- 26/05/2015
- 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
Mr M Clarke
Scientific
Scientific
Claremont Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
| m.p.clarke@newcastle.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Not specified, Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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)] |
| Study acronym | Pilot RCT comparing Surgery to Observation for Intermittent Exotropia |
| Study objectives | 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(s) | 10/H0904/57 |
| Health condition(s) or problem(s) studied | Topic: Eye; Subtopic: Eye (all Subtopics); Disease: Ophthalmology |
| Intervention | Eye muscle surgery |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Number of patients; Timepoint(s): To determine whether participating centres are likely to recruit a sufficient number of patients |
| Key secondary outcome measure(s) |
1. Pilot procedures; Timepoint(s): To pilot procedures involved in the trial including recruitment, randomisation, surgery and masking |
| Completion date | 01/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 144 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2011 |
| Date of final enrolment | 01/12/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Royal Victoria Infirmary
Newcastle Upon Tyne
NE1 4LP
United Kingdom
NE1 4LP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2015 | Yes | No | |
| Protocol article | protocol | 16/10/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
