Objective Assessment of Disparity Vergence After Treatment of Symptomatic CI in Children (NCT03248336) | Clinical Trial Compass
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Objective Assessment of Disparity Vergence After Treatment of Symptomatic CI in Children
United States60 participantsStarted 2018-09-02
Plain-language summary
This study is designed to evaluate changes in objective measures of disparity vergence after office-based vergence/accommodative therapy (OBVAT) for convergence insufficiency (CI) in children 12-17 years old.
Who can participate
Age range
9 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:
* CI Symptom Survey score ≥ 16
* Exophoria at near at least 4 greater than at far
* Receded near point of convergence (NPC) of 6 cm break
* Insufficient positive fusional vergence (PFV) at near (i.e., failing Sheard's criterion or PFV ≤15 base-out break)
* Best-corrected distance visual acuity of 20/25 or better in each eye
* Random dot stereopsis appreciation of 500 seconds of arc or better
* Wearing appropriate refractive correction (spectacles of contact lenses) for at least 2 weeks prior to final determination of eligibility for any of the following uncorrected refractive errors (based on cycloplegic refraction within prior 12 months)
* No use of BI prism or plus add at near for 2 weeks prior to study and for duration of study
Exclusion Criteria:
* Constant strabismus at distance or near
* Esophoria of ≥ 2∆ at distance
* Vertical heterophoria ≥ 2∆ at distance or near
* ≥ 2 line interocular difference in best-corrected visual acuity
* Near point of accommodation \>20 cm in either eye as measured by push-up method
* Manifest or latent nystagmus
* History of strabismus surgery or refractive surgery
* CI associated with head trauma or known disease of the brain
* Diseases known to affect accommodation, vergence, or ocular motility
* Inability to comprehend and/or perform any study-related test
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Change in average peak velocity for 4° symmetrical convergence steps after 12 weeks of therapy