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Related Experiment Videos

Surgery versus Active Monitoring in Intermittent Exotropia (SamExo): study protocol for a pilot randomised controlled

Deborah Buck1, Elaine McColl, Christine J Powell

  • 1Institute of Neuroscience, c/o Clinical Trials Unit, Medical School, Newcastle University, Newcastle upon Tyne, UK. deborah.buck@newcastle.ac.uk

Trials
|October 18, 2012
PubMed
Summary

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Open Angle Glaucoma: Treatment01:27

Open Angle Glaucoma: Treatment

In open-angle glaucoma, the iridocorneal angle remains open, but the trabecular meshwork becomes stiff, slowing down the outflow of aqueous humor. This causes a buildup of aqueous humor in the anterior chamber, leading to a sudden increase in intraocular pressure. The treatment for open-angle glaucoma focuses on reducing the elevated intraocular pressure by either decreasing the secretion of aqueous humor or increasing its outflow.
Drugs such as carbonic anhydrase inhibitors, α2- and...

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This pilot study assesses the feasibility of a trial comparing surgery versus active monitoring for childhood intermittent exotropia (X(T)). Results will guide a definitive randomized controlled trial for managing this common eye condition.

Area of Science:

  • Ophthalmology
  • Pediatric Ophthalmology
  • Clinical Trials

Background:

  • Childhood intermittent exotropia (X(T)) is a common strabismus with varied management options.
  • Lack of consensus and limited evidence exist for optimal X(T) treatment, particularly comparing surgery and active monitoring.
  • The SamExo pilot study aims to evaluate the feasibility of a randomized controlled trial (RCT) in the UK.

Purpose of the Study:

  • To test the feasibility of conducting a full RCT comparing surgery versus active monitoring for childhood intermittent exotropia.
  • To gather data on recruitment, retention, and outcome measure completion for a definitive trial.
  • To inform the design and power calculations for a future large-scale RCT.

Main Methods:

  • An external pilot patient-randomized controlled trial conducted across four UK secondary ophthalmology centers.

Related Experiment Videos

  • Recruitment of 144 children aged 6 months to 16 years with suspected or diagnosed X(T).
  • Randomization to either eye muscle surgery or active monitoring, with assessments at 3, 6, and 9 months.

    • Main Results:

    • The study will report on recruitment and retention rates, participation and follow-up biases, and reasons for participation decisions.
    • Variability in cure rates will be assessed to inform power calculations for a definitive RCT.
    • Completion rates of outcome measures, including quality of life questionnaires, will be analyzed.

    Conclusions:

    • The SamExo pilot trial is crucial for determining the feasibility of a full RCT on surgical versus active monitoring interventions for X(T).
    • Pilot study findings, including cure rate differences, will directly inform the methodology of a definitive RCT.
    • This research will provide essential data to guide future clinical practice and research in childhood intermittent exotropia management.