Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia

• Sponsor: Indiana University School of Medicine (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02466659
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arms: 2
• Actual Duration (Months): 22
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Intermittent Exotropia	Device: CIAO therapy Amblyz glasses	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Clinical Trial of Observation Versus Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia
• Actual Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in Composite Measure of IXT Control Score [12 weeks; 24 weeks]

   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

Other Outcome Measures

1. Amblyopia [3 Months]

   It is defined when visual acuity between two eyes equal or over 2 logMAR lines.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 11 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Glick Eye Institute, Indiana University School of Medicine	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Indiana University School of Medicine

Investigators

• Principal Investigator: Daniel E Neely, MD, Glick Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel E. Neely, Professor of Ophthalmology, Indiana University
• ClinicalTrials.gov Identifier: NCT02466659
• Other Study ID Numbers: IndianU
• First Posted: Jun 9, 2015
• Last Update Posted: Nov 30, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Daniel E. Neely, Professor of Ophthalmology, Indiana University: IXT
• Additional relevant MeSH terms: Exotropia

Study Results

Participant Flow

Arm/Group Title	CIAO Therapy	Observation
Arm/Group Description	Intervention with wearing 3-hour daily CIAO therapy glasses CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses	To observe as one kind of standard care for IXT.
Period Title: Overall Study
STARTED	5	3
COMPLETED	0	1
NOT COMPLETED	5	2

Baseline Characteristics

Arm/Group Title	CIAO Therapy	Observation	Total
Arm/Group Description	Intervention with wearing 3-hour daily CIAO therapy glasses CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses	To observe as one kind of standard care for IXT.	Total of all reporting groups
Overall Participants	5	3	8
Age (Year) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Year]	5.7 (1.94)	6.24 (4.17)	5.91 (2.68)
Sex: Female, Male (Count of Participants)
Female	3 60%	2 66.7%	5 62.5%
Male	2 40%	1 33.3%	3 37.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	5 100%	3 100%	8 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
IXT Control Score at distance (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4 (.71)	2.67 (.57)	3.5 (.92)

Outcome Measures

1. Primary Outcome

Title	Change in Composite Measure of IXT Control Score
Description	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
Time Frame	12 weeks; 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CIAO Therapy	Observation
Arm/Group Description	Intervention with wearing 3-hour daily CIAO therapy glasses CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses	To observe as one kind of standard care for IXT.
Measure Participants	0	1
Mean (Standard Deviation) [units on a scale]	5

2. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CIAO Therapy	Observation
Arm/Group Description	Intervention with wearing 3-hour daily CIAO therapy glasses CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses	To observe as one kind of standard care for IXT.
Measure Participants	0	1
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	3MO
Arm/Group Title	CIAO Therapy		Observation
Arm/Group Description	Intervention with wearing 3-hour daily CIAO therapy glasses CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses		To observe as one kind of standard care for IXT.
All Cause Mortality
	CIAO Therapy		Observation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/3 (0%)
Serious Adverse Events
	CIAO Therapy		Observation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	CIAO Therapy		Observation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.