Observation Versus Occlusion Therapy for Intermittent Exotropia (NCT01032330) | Clinical Trial Compass
CompletedNot Applicable
Observation Versus Occlusion Therapy for Intermittent Exotropia
United States611 participantsStarted 2010-01
Plain-language summary
The present study is being conducted to assess the natural history of intermittent exotropia and to establish the effectiveness of occlusion in its treatment.
Study Objectives:
* To determine the effectiveness of occlusion for the treatment of intermittent exotropia among patients aged 3 to \< 11 years who have baseline near stereoacuity of 400 arcsec or better by Preschool Randot stereotest
* To determine the natural history of intermittent exotropia among patients aged 3 to \< 11 years who have baseline near stereoacuity of 400 arcsec or better by Preschool Randot stereotest
Who can participate
Age range
12 Months – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 12 months to \< 11 years
* Intermittent exotropia (manifest deviation) meeting all of the following criteria:
* Intermittent exotropia at distance OR constant exotropia at distance and either intermittent exotropia or exophoria at near
* Exodeviation at least 15PD at distance OR near measured by prism and alternate cover test (PACT)
* Exodeviation at least 10PD at distance measured by PACT
* No previous surgical or non-surgical treatment for IXT (other than refractive correction)
* Visual acuity in the worse eye at least 0.3 logMAR (20/40 on ATS HOTV or 70 letters on E-ETDRS) for children ≥ 3 years of age
* No interocular difference of visual acuity more than 0.2 logMAR (2 lines on ATS HOTV or 10 letters on E-ETDRS) for children ≥ 3 years of age
* No hyperopia greater than +3.50 D spherical equivalent in either eye
* No myopia greater than -6.00 D spherical equivalent in either eye
* No prior strabismus, intraocular, or refractive surgery
* No abnormality of the cornea, lens, or central retina
* Investigator willing to observe the IXT untreated for 3 years unless specific criteria for deterioration are met
Exclusion Criteria:
* Pure phoria at both distance and near
* Prior non-surgical treatment for IXT other than refractive correction (e.g., vergence therapy, occlusion, vision therapy/orthoptics, or deliberate over-minus with spectacles more than 0.50D)
* Previous amblyopia treatment other than refractive correction within 1 year
* Vision …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared simply watching intermittent exotropia versus using occlusion (patching) therapy — based on what the study found over 3 years, which approach does the research suggest is better for my child's specific age group and severity?
2The trial tracked 'deterioration' as its main measure — can you explain what counts as deterioration in intermittent exotropia, and how would we know if my child's condition is getting worse under either approach?
3Since the trial had both a younger and an older age cohort, which group does my child fall into, and does the evidence from that specific cohort change your recommendation about whether to treat now or observe?
4Now that this study is completed, has it changed how eye doctors generally think about patching as a first-line treatment for intermittent exotropia, or is surgery or another option still considered better in some cases?
5If we decide to start with observation rather than patching, what signs or changes in my child's eye alignment or vision should prompt us to come back sooner and reconsider treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.