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Trial Outcomes & Findings for Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia (NCT NCT02466659)

NCT ID: NCT02466659

Last Updated: 2017-11-30

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

12 weeks; 24 weeks

Results posted on

2017-11-30

Participant Flow

Participant milestones

Participant milestones
Measure
CIAO Therapy
Intervention with wearing 3-hour daily CIAO therapy glasses CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses
Observation
To observe as one kind of standard care for IXT.
Overall Study
STARTED
5
3
Overall Study
COMPLETED
0
1
Overall Study
NOT COMPLETED
5
2

Reasons for withdrawal

Reasons for withdrawal
Measure
CIAO Therapy
Intervention with wearing 3-hour daily CIAO therapy glasses CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses
Observation
To observe as one kind of standard care for IXT.
Overall Study
Lost to Follow-up
5
2

Baseline Characteristics

Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
CIAO Therapy
n=5 Participants
Intervention with wearing 3-hour daily CIAO therapy glasses CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses
Observation
n=3 Participants
To observe as one kind of standard care for IXT.
Total
n=8 Participants
Total of all reporting groups
Age, Continuous
5.7 Year
STANDARD_DEVIATION 1.94 • n=5 Participants
6.24 Year
STANDARD_DEVIATION 4.17 • n=7 Participants
5.91 Year
STANDARD_DEVIATION 2.68 • n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
White
5 Participants
n=5 Participants
3 Participants
n=7 Participants
8 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
IXT Control Score at distance
4 units on a scale
STANDARD_DEVIATION .71 • n=5 Participants
2.67 units on a scale
STANDARD_DEVIATION .57 • n=7 Participants
3.5 units on a scale
STANDARD_DEVIATION .92 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
CIAO Therapy
Intervention with wearing 3-hour daily CIAO therapy glasses CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses
Observation
n=1 Participants
To observe as one kind of standard care for IXT.
Change in Composite Measure of IXT Control Score
—
5 units on a scale

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months

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

Outcome measures

Outcome measures
Measure
CIAO Therapy
Intervention with wearing 3-hour daily CIAO therapy glasses CIAO therapy Amblyz glasses: 3-hour CIAO Therapy Amblyz glasses
Observation
n=1 Participants
To observe as one kind of standard care for IXT.
Amblyopia
0 Participants
0 Participants

Adverse Events

CIAO Therapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Observation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel Neely

Indiana University

Phone: 3172741214

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place