Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia

Indiana University School of Medicine8 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Intermittent Exotropia

Interventions

CIAO therapy Amblyz glassesDEVICE

3-hour CIAO Therapy Amblyz glasses

Eligibility

Sex: ALLMin age: 3 YearsMax age: 11 Years

Medical Language ↔ Plain English

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

Locations (1)

Glick Eye Institute, Indiana University School of Medicine

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Change in Composite Measure of IXT Control Score

IXT control score: referring to the Pediatric eye disease investigator group (PEDIG). PEDIG scale of control for IXT 1-5 is defined as the following: 5 = Constant exotropia 4 = exotropia \> 50% of the 30-sec period before dissociation 3 = exotropia \< 50% of the 30-sec period before dissociation 2 = No exotropia unless dissociated, recovers in \> 5 sec 1 = No exotropia unless dissociated, recovers in 1-5 sec 0 = No exotropia unless dissociated, recovers in \< 1 sec (phoria) Not Applicable = No exotropia present

Time frame: 12 weeks; 24 weeks

Data from ClinicalTrials.gov

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