Intermittent ExotropiaCIAONCT02466659
Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia
A study testing CIAO therapy Amblyz glasses in people with Intermittent Exotropia, run by Indiana University at 1 site in United States.
Trial summary
To determine the effectiveness of alternate occlusion therapy for the treatment of IXT among patients aged 3 to < 11 years old. Read more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- Intermittent Exotropia
- What is being tested?
- CIAO therapy Amblyz glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2015to 1 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 13Show fewer
- 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.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Glick Eye Institute, Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
Official title: 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.
Read the 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.
- Conditions
- Intermittent Exotropia
- Being tested
- CIAO therapy Amblyz glasses
- Keywords
- IXT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIAO therapy Amblyz glassesDevice
3-hour CIAO Therapy Amblyz glasses
| Study group | Role | What they receive |
|---|---|---|
| CIAO Therapy | Experimental | Intervention with wearing 3-hour daily CIAO therapy glasses Receives: Device: CIAO therapy Amblyz glasses |
| Observation | No intervention | To observe as one kind of standard care for IXT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks; 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study start1 Feb 2015
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Why it stopped: no fund
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intermittent ExotropiaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel E. Neely, Indiana University
- Investigators
- Daniel E Neely, MD, Principal investigator, Glick Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466659
- Sponsor's protocol ID
- IndianU
- Acronym
- CIAO
- Status last verified
- Oct 2017
- First submitted
- 14 Apr 2015
- Last updated
- 30 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Observation Versus Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia
- ClinicalTrials.gov ID
- NCT02466659
- Acronym / sponsor ID
- CIAO / IndianU
- Conditions
- Intermittent Exotropia
- Keywords
- IXT
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no fund
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Posted 30 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effectiveness of alternate occlusion therapy for the treatment of IXT among patients aged 3 to < 11 years old.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIAO Therapy | Experimental | Device: CIAO therapy Amblyz glassesIntervention with wearing 3-hour daily CIAO therapy glasses |
| Observation | No intervention | –To observe as one kind of standard care for IXT. |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Intermittent exotropia (manifest deviation) meeting all of the following criteria:
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CIAO therapy Amblyz glasses3-hour CIAO Therapy Amblyz glasses | Device | CIAO Therapy |
Primary outcome
Change in Composite Measure of IXT Control Score
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel E Neely, MD principal investigator
Glick Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CIAO therapy Amblyz glasses in people with Intermittent Exotropia, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Composite Measure of IXT Control Score (time frame: 12 weeks; 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.