CompletedPhase 3

Full-Time Occlusion Therapy for Intermittent Exotropia in Children

United States73 participantsStarted 2022-11-01

Plain-language summary

Determine whether full-time patching is more effective than observation for improving distance control of IXT after 3 months of treatment (on-treatment outcome).

Who can participate

Age range3 Years – 8 Years

SexALL

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Inclusion criteria

✓. Age 3 to \< 9 years
✓. IXT meeting all of the following criteria:
✓. Age-normal visual acuity in both eyes:
✓. Interocular difference in distance VA of 2 logMAR lines or less (10 letters or less on E-ETDRS for patients ≥7 years old). Testing by ATS HOTV for participants 3 to \< 7 years old and by E-ETDRS for participants ≥7 years old.
✓. Cycloplegic refraction within the last 7 months.
✓. Refractive error between -6.00 D SE and +2.00 D SE (inclusive) based on a cycloplegic refraction within 7 months
✓. Participants with refractive error meeting any of the following based on a cycloplegic refraction within 6 months must be wearing spectacles for at least 2 weeks:
✓. Any refractive correction worn at enrollment (required or not) must meet the following guidelines based on a cycloplegic refraction within 7 months:

Exclusion criteria

✕. Prior strabismus, intraocular, or refractive surgery (including BOTOX injection)
✕. Prior nonsurgical treatment for IXT (e.g., patching, vergence therapy, vision therapy/orthoptics, base-in prism, or deliberate overminus (more than 1.00 D) spectacles of \>1week duration within the past year
✕. Previous amblyopia treatment other than refractive correction
✕. Diplopia more than 2 times per day by parental assessment
✕. Paretic or restrictive strabismus
✕. Craniofacial malformations affecting the orbits
✕. Ocular disorders which would reduce VA (except refractive error)
✕. Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities or ADHD are not excluded.

What they're measuring

Number of Participants With a Change in Mean Distance Control Scores at 3 Months

Timeframe: 3 months

Trial details

NCT IDNCT05462821

SponsorJaeb Center for Health Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-01

Results submitted2025-11-06

View on ClinicalTrials.gov More Intermittent Exotropia trials