Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia (CIAO)

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

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

Study Overview

• Status: Terminated
• Conditions: Intermittent Exotropia
• Intervention / Treatment: Device: CIAO therapy Amblyz glasses

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Glick Eye Institute, Indiana University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 11 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CIAO Therapy; Intervention with wearing 3-hour daily CIAO therapy glasses	Device: CIAO therapy Amblyz glasses; 3-hour CIAO Therapy Amblyz glasses
NO_INTERVENTION: Observation; To observe as one kind of standard care for IXT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 weeks; 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amblyopia	It is defined when visual acuity between two eyes equal or over 2 logMAR lines.	3 Months

Collaborators and Investigators

• Sponsor: Indiana University School of Medicine
• Investigators: Principal Investigator: Daniel E Neely, MD, Glick Eye Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2015
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: April 14, 2015
• First Submitted That Met QC Criteria: June 5, 2015
• First Posted (ESTIMATE): June 9, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2017
• Last Update Submitted That Met QC Criteria: October 22, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: IXT
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Strabismus; Exotropia
• Other Study ID Numbers: IndianU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO