Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia

Indiana University School of Medicine

Status

Terminated

Conditions

Intermittent Exotropia

Treatments

Device: CIAO therapy Amblyz glasses

Study type

Interventional

Funder types

Other

Identifiers

NCT02466659

IndianU

Details and patient eligibility

About

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

Full 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.

Enrollment

8 patients

Sex

All

Ages

3 to 11 years old

Volunteers

No Healthy Volunteers

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.