Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia

NCT02466659 | Terminated Results DMC

• 1 other identifier: IndianU
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intermittent Exotropia

Keywords

IXT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Amblyopia

  3 Months

Study Arms (2)

CIAO Therapy

EXPERIMENTAL

Intervention with wearing 3-hour daily CIAO therapy glasses

Device: CIAO therapy Amblyz glasses

Observation

NO INTERVENTION

To observe as one kind of standard care for IXT.

Interventions

CIAO therapy Amblyz glasses DEVICE

3-hour CIAO Therapy Amblyz glasses

CIAO Therapy

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Indiana University School of Medicine: lead

Study Sites (1)

Glick Eye Institute, Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Results Point of Contact

• Title: Daniel Neely
• Organization: Indiana University

deneely@iupui.edu

3172741214

Study Officials

• Daniel E Neely, MD

  Glick Eye Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: June 9, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 30, 2017
• Results First Posted: November 30, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)