Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia

Intermittent Exotropia Clinical Trial

— CIAO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02466659
• Other study ID #: IndianU
• Status: Terminated
• Phase: N/A
• First received: April 14, 2015
• Last updated: October 22, 2017
• Start date: February 1, 2015
• Est. completion date: December 1, 2016

Study information

• Verified date: October 2017
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 11 Years

Eligibility

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:

Related Conditions & MeSH terms

• Exotropia
• Intermittent Exotropia

Intervention

Device:
• CIAO therapy Amblyz glasses
3-hour CIAO Therapy Amblyz glasses

Locations

Country	Name	City	State
United States	Glick Eye Institute, Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Amblyopia	It is defined when visual acuity between two eyes equal or over 2 logMAR lines.	3 Months
Primary	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