Clinical trial NCT02466659: Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia
Official title: A Clinical Trial of Observation Versus Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intermittent Exotropia
Keywords: IXT
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 8
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effectiveness of alternate occlusion therapy for the treatment of IXT among patients aged 3 to \< 11 years old.

Detailed description: Intermittent exotropia (IXT) is the most common form of childhood-onset exotropia with an incidence of 32.1 per 100,000 in children. Before surgery, many cases of IXT are treated using non-surgical interventions, such as part-time alternate occlusion. However, the "alternating" occlusion with traditional patches is usually out of control. The investigators are uncertain about the amount of "alternating" in patching treatment.

Here, the investigators introduce controlled intermittent alternating occlusion (CIAO) therapy, which is provided by a new electronic device, -liquid crystal glasses. This study is to determine the effectiveness of alternate occlusion therapy for the treatment of IXT among patients aged 3 to \< 11 years old. Children with IXT will be randomized into either an observation group or a CIAO therapy group.

Eligibility criteria: Inclusion Criteria:

* 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 15PD at distance OR near measured by prism and alternate cover test (PACT)
  * Exodeviation at least 10PD at distance measured by PACT
* No previous surgical or non-surgical treatment for IXT (other than refractive correction)
* Visual acuity in the worse eye 0.3 logMAR or better (20/40 on ATS HOTV or 70 letters on E-ETDRS) for children ≥ 3 years of age
* No interocular difference of visual acuity more than 0.2 logMAR (2 lines on ATS HOTV or 10 letters on E-ETDRS) for children ≥ 7 years of age
* Investigator not planning to initiate amblyopia treatment
* No hyperopia greater than +3.50 D spherical equivalent in either eye
* No myopia greater than -6.00 D spherical equivalent in either eye
* No prior strabismus, intraocular, or refractive surgery
* No abnormality of the cornea, lens, or central retina
* Investigator willing to observe the IXT untreated for 3 years unless specific criteria for deterioration are met.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Change in Composite Measure of IXT Control Score
timeFrame: 12 weeks; 24 weeks
Secondary outcomes:
Other outcomes:
measure: Amblyopia
timeFrame: 3 Months
Locations:
city: Indianapolis
country: United States
facility: Glick Eye Institute, Indiana University School of Medicine
state: Indiana
Study officials:
affiliation: Glick Eye Institute
name: Daniel E Neely, MD
role: PRINCIPAL_INVESTIGATOR
References: