Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia

NCT ID: NCT02466659

Last Updated: 2017-11-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-01
• Study Completion Date: 2016-12-01

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.

Conditions

Intermittent Exotropia

Keywords

IXT

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CIAO Therapy

Intervention with wearing 3-hour daily CIAO therapy glasses

Group Type: EXPERIMENTAL

CIAO therapy Amblyz glasses

Intervention Type: DEVICE

3-hour CIAO Therapy Amblyz glasses

Observation

To observe as one kind of standard care for IXT.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CIAO therapy Amblyz glasses

3-hour CIAO Therapy Amblyz glasses

Intervention Type: DEVICE

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Daniel E. Neely

Professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel E Neely, MD

Role: PRINCIPAL_INVESTIGATOR

Glick Eye Institute

Locations

Glick Eye Institute, Indiana University School of Medicine

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

IndianU

Identifier Type: -

Identifier Source: org_study_id