Office Based Vergence/Accommodative Therapy for the Treatment of Intermittent Exotropia (NCT04744779) | Clinical Trial Compass
UnknownNot Applicable
Office Based Vergence/Accommodative Therapy for the Treatment of Intermittent Exotropia
40 participantsStarted 2021-03
Plain-language summary
Effectiveness of office based vergence/accommodative therapy for the treatment of intermittent exotropia is investigated through a randomized clinical trial
Who can participate
Age range
6 Years – 17 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
. 6 to \<18 years old
. Distance exodeviation between 10 and 30 prism diopters (PD) measured by prism and alternate cover test (PACT)
. Near deviation not exceeding the distance deviation by \>10PD by PACT (i.e., convergence insufficiency type intermittent exotropia excluded)
. Control of deviation meeting all the following criteria based on the office control score scale:
.1 Intermittent or constant exotropia at distance (mean of 3 baseline assessments of distance control ≥ Grade 2)# 4.2 Intermittent exotropia or exophoria at near (at least 1 of 3 assessments of near control at the baseline visit Grade 0-4) or orthophoria
. Stereoacuity: near stereoacuity of 400 arcsec or better by the Preschool Randot stereotest
. Cycloplegic subjective refraction spherical equivalent (SE) refractive error between -6.00 diopters (D)and +3.50 D inclusive in either eye
. Must be wearing the updated refractive correction (spectacles) for at least 2 weeks if refractive error (based on cycloplegic subjective refraction performed within 6 months) meets any of the following:
Exclusion criteria
. Amblyopia, nystagmus, restrictive or paretic strabismus
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 is comparing two groups using something called an 'office control score' for intermittent exotropia — can you explain what that score actually measures, and how it would tell us whether the vergence and accommodative therapy is working?
2Since this trial is listed as Phase NA and its recruitment status is unknown, is it still actively enrolling patients, and would it even be an option worth pursuing right now?
3The therapy in this trial is described as 'office-based' — how many visits would that likely require, and given our schedule and location, is that level of commitment realistic for us?
4Are there established treatments for intermittent exotropia, like patching, surgery, or standard vision therapy, that you'd recommend we consider first before thinking about a research study like this one?
5Since this is studying a therapy approach rather than a drug, what is already known about the safety of vergence and accommodative therapy for intermittent exotropia, and are there any risks we should be aware of before discussing enrollment with the study team?
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.
What they're measuring
1
Comparison of the distant office control score between two groups at the primary outcome visit
. Regular use of any ocular or systemic medications known to affect accommodation or vergence system, such as atropine, pirenzepine, and anti-epileptic medications, in the most recent 3 months
. Developmental disability, attention-deficit/hyperactivity disorder (ADHD), or learning disability diagnosis in children that in the investigator's discretion would interfere with office-based treatment
. Relocation anticipated within 2 year
. Significant ocular or neurologic disorders (e.g. cerebral palsy) other than strabismus