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Clinical Trials/NCT02902887
NCT02902887
Unknown
Not Applicable

A Clinical Trial of Observation Versus Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia

Salus University1 site in 1 country60 target enrollmentStarted: August 2016Last updated:
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ConditionsIntermittent Exotropia

Overview

Phase
Not Applicable
Enrollment
60
Locations
1
Primary Endpoint
Control of the exodeviation assessment (scaled 1-5)
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief 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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
3 Years to 11 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •The following criteria must be met for the patient to be enrolled in the study:
  • •Age 3 to 11 years old
  • •Intermittent exotropia (manifest deviation) meeting all of the following criteria:
  • •Intermittent exotropia at distance OR constant exotropia at distance and either intermittent exotropia or exophoria at near
  • •Exodeviation at least 10PD at distance OR 15PD at near measured by prism and alternate cover test (PACT)
  • •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:

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

Outcomes

Primary Outcomes

Control of the exodeviation assessment (scaled 1-5)

Time Frame: 3-month

Intermittent Exotropia Control Scale (1-5) 5 = Constant exotropia 4 = Exotropia \> 50% of the 30-second period before dissociation 3 = Exotropia \< 50% of the 30-second period before dissociation 2 = No exotropia unless dissociated, recovers in \> 5 seconds 1 = No exotropia unless dissociated, recovers in 1-5 seconds 0 = No exotropia unless dissociated, recovers in \< 1 second (phoria)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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