UnknownNot Applicable

Monitored Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia

United States60 participantsStarted 2016-08

Plain-language summary

This study presents an opportunity to understand a novel, previously unreported controlled intermittent alternate occlusion (CIAO) therapy glasses, which may improve the control of Intermittent exotropia (IXT).

Who can participate

Age range

3 Years – 11 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 3 to 11 years old
. Intermittent exotropia (manifest deviation) meeting all of the following criteria:
. No previous surgical or non-surgical treatment for IXT (other than refractive correction)
. Visual acuity in the worse eye 20/40 (0.3 logMAR) or better on ATS HOTV for ages 3 - 5 and 20/25 (0.1 logMAR) or better on ATS HOTV for ages 6 - 11
. No hyperopia greater than +3.50 D spherical equivalent in either eye
. No myopia greater than -6.00 D spherical equivalent in either eye
. Patients must be wearing refractive correction (spectacles or contact lenses) for at least one week if refractive error (based on cycloplegic refraction performed within 6 months) meets any of the following:
. No atropine use within the last week

Exclusion criteria

. Only 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)

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

Control of the exodeviation assessment (scaled 1-5)

Timeframe: 3-month

Trial details

NCT IDNCT02902887

SponsorSalus University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05

Contact for this trial

Jingyun Wang, PhD

215-780-1376 jwang@salus.edu

View on ClinicalTrials.gov More Intermittent Exotropia trials