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 range3 Years – 11 Years

SexALL

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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)
✕. Previous amblyopia treatment other than refractive correction within 1 year
✕. Vision therapy/orthoptics for any reason within the last year
✕. Interocular visual acuity difference more than 0.2 logMAR (2 lines on ATS HOTV for patients 3 to \< 7 years old or 10 letters on E-ETDRS for patients ≥ 7 years old)
✕. Investigator planning to initiate amblyopia treatment

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