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 range6 Years – 17 Years

SexALL

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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
✕. 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
✕. Vertical deviation greater than 3 pd
✕. Household member already in the study

What they're measuring

Comparison of the distant office control score between two groups at the primary outcome visit

Timeframe: 16 months

Trial details

NCT IDNCT04744779

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06

View on ClinicalTrials.gov More Intermittent Exotropia trials