Surgery versus Active Monitoring in Intermittent Exotropia (SamExo): study protocol for a pilot randomised controlled trial.
BACKGROUND
Childhood intermittent exotropia [X(T)] is a type of strabismus (squint) in which one eye deviates outward at times, usually when the child is tired. It may progress to a permanent squint, loss of stereovision and/or amblyopia (reduced vision). Treatment options for X(T) include eye patches, glasses, surgery and active monitoring. There is no consensus regarding how this condition should be managed, and even when surgery is the preferred option clinicians disagree as to the optimal timing. Reports on the natural history of X(T) are limited, and there is no randomised controlled trial (RCT) evidence on the effectiveness or efficiency of surgery compared with active monitoring. The SamExo (Surgery versus Active Monitoring in Intermittent Exotropia) pilot study has been designed to test the feasibility of such a trial in the UK.


METHODS



METHODS
an external pilot patient randomised controlled trial.


METHODS
four UK secondary ophthalmology care facilities at Newcastle NHS Hospitals Foundation Trust, Sunderland Eye Infirmary, Moorfields Eye Hospital and York NHS Trust.


METHODS
children aged between 6 months and 16 years referred with suspected and subsequently diagnosed X(T). Recruitment target is a total of 144 children over a 9-month period, with 120 retained by 9-month outcome visit.Randomisation: permuted blocks stratified by collaborating centre, age and severity of X(T).


METHODS
initial clinical assessment; randomisation (eye muscle surgery or active monitoring); 3-, 6- and 9-month (primary outcome) clinical assessments; participant/proxy completed questionnaire covering time and travel costs, health services use and quality of life (Intermittent Exotropia Questionnaire); qualitative interviews with parents to establish reasons for agreeing or declining participation in the pilot trial.


RESULTS
recruitment and retention rates; nature and extent of participation bias; nature and extent of biases arising from crossover or loss to follow-up; reasons for agreeing/declining participation; variability of cure rates (to inform power calculations for a definitive RCT); completion rates of outcome measures.


CONCLUSIONS
The SamExo pilot trial will provide important pointers regarding the feasibility of a full RCT of immediate surgery versus deferred surgery/active monitoring. The results of this pilot, including differences in cure rates, will inform the design of a definitive RCT.


BACKGROUND
ISRCTN44114892.
Institute of Neuroscience, c/o Clinical Trials Unit, Medical School, Newcastle University, Newcastle upon Tyne, UK. deborah.buck@newcastle.ac.uk
Deborah
D
Buck
Elaine
E
McColl
Christine J
CJ
Powell
Jing
J
Shen
John
J
Sloper
Nick
N
Steen
Robert
R
Taylor
Peter
P
Tiffin
Luke
L
Vale
Michael P
MP
Clarke
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D002985:Clinical Protocols; D005099:Exotropia / Q000601:surgery*; D006801:Humans; D007223:Infant; D017063:Outcome Assessment, Health Care; D010865:Pilot Projects; D036301:Qualitative Research; D018401:Sample Size