Intermittent ExotropiaNCT02902887
Monitored Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia
A study of Intermittent Exotropia, run by Salus University at 1 site in United States.
Trial summary
This study presents an opportunity to understand a novel, previously unreported controlled intermittent alternate occlusion (CIAO) therapy glasses, which may improve the control of Intermittent exotropia (IXT). Read more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- Intermittent Exotropia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- The following criteria must be met for the patient to be enrolled in the study:
- Age 3 to 11 years old
- 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 10PD at distance OR 15PD at near measured by prism and alternate cover test (PACT)
- No previous surgical or non-surgical treatment for IXT (other than refractive correction)
Show all 23Show fewer
- Visual acuity in the worse eye 20/40 (0.3 logMAR) or better on ATS HOTV for ages 3 - 5 and 20/25 (0.1 logMAR) or better on ATS HOTV for ages 6 - 11
- No hyperopia greater than +3.50 D spherical equivalent in either eye
- No myopia greater than -6.00 D spherical equivalent in either eye
- Patients must be wearing refractive correction (spectacles or contact lenses) for at least one week if refractive error (based on cycloplegic refraction performed within 6 months) meets any of the following:
- Myopia > -0.50 D spherical equivalent in either eye
- Anisometropia > 1.00 D spherical equivalent
- Astigmatism in either eye > 2.00 D if ≤ 5 years old and > 1.50 D if > 5 years old
- Refractive correction for patients meeting the above refractive error criteria must meet the following guidelines:
- Anisometropia spherical equivalent must be within 0.25D of the full anisometropic difference correction
- Astigmatism cylinder must be within 0.25D of full correction and axis must be within 5 degrees of full correction.
- For hyperopia, the spherical component can be reduced at investigator discretion provided the reduction is symmetrical. Prescribing any refractive correction to yield lenses that are more myopic than -0.50 D spherical equivalent (SE) is considered deliberate overminus and is not allowed at enrollment. However, prescribing no correction or prescribing less than the full cycloplegic hyperopic correction (i.e., prescribing reduced plus) is not considered the same as overminusing for this protocol and is allowed because most patients without IXT but with hyperopic SE refractions in this range would not typically be prescribed a refractive correction.
- For myopia, the intent is to fully correct, but the spherical component can be undercorrected by investigator discretion provided the reduction is symmetrical and results in no more than -0.50 D SE residual (i.e., uncorrected) myopia. Prescribing a correction that yields more than 0.50 D more minus SE than the cycloplegic refraction SE is considered deliberate overminus and is not allowed at enrollment.
- Note that the refractive correction guidelines and the requirement to wear refractive correction for at least one week apply not only to patients who require refractive correction under the above criteria but also to any other patient who is wearing refractive correction.
- No atropine use within the last week
- Gestational age > 34 weeks and birth weight > 1500 grams
- Patient and/or parent is willing to accept randomization to either observation or CIAO therapy.
- Parent has a phone (or access to phone) and is willing to be contacted
Who cannot join
- Only phoria at both distance and near
- Prior non-surgical treatment for IXT other than refractive correction (e.g., vergence therapy, occlusion, vision therapy/orthoptics, or deliberate over-minus with spectacles more than 0.50D)
- Previous amblyopia treatment other than refractive correction within 1 year
- Vision therapy/orthoptics for any reason within the last year
- Interocular visual acuity difference more than 0.2 logMAR (2 lines on ATS HOTV for patients 3 to < 7 years old or 10 letters on E-ETDRS for patients ≥ 7 years old)
- Investigator planning to initiate amblyopia treatment
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Salus University
Elkins Park, Pennsylvania
Jingyun Wang
About this study
Official title: A Clinical Trial of Observation Versus Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia
This study presents an opportunity to understand a novel, previously unreported controlled intermittent alternate occlusion (CIAO) therapy glasses, which may improve the control of Intermittent exotropia (IXT).
- Conditions
- Intermittent Exotropia
- Being tested
- Controlled Intermittent Alternate Occlusion (CIAO ) glasses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled Intermittent Alternate Occlusion (CIAO ) glassesDevice
Monitored CIAO therapy glasses
| Study group | Role | What they receive |
|---|---|---|
| Monitored CIAO therapy | Experimental | Participants wear 3-hour CIAO therapy Receives: Device: Controlled Intermittent Alternate Occlusion (CIAO ) glasses |
| Observation | No intervention | No intervention, just observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of the exodeviation assessment (scaled 1-5)
Intermittent Exotropia Control Scale (1-5) 5 = Constant exotropia 4 = Exotropia > 50% of the 30-second period before dissociation 3 = Exotropia < 50% of the 30-second period before dissociation 2 = No exotropia unless dissociated, recovers in > 5 seconds
1 = No exotropia unless dissociated, recovers in 1-5 seconds 0 = No exotropia unless dissociated, recovers in < 1 second (phoria)
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ExotropiaStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902887
- Sponsor's protocol ID
- HJW1601
- Status last verified
- Apr 2019
- First submitted
- 8 May 2016
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. 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
- NCT02902887
- Acronym / sponsor ID
- HJW1601
- Conditions
- Intermittent Exotropia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Salus UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study presents an opportunity to understand a novel, previously unreported controlled intermittent alternate occlusion (CIAO) therapy glasses, which may improve the control of Intermittent exotropia (IXT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitored CIAO therapy | Experimental | Device: Controlled Intermittent Alternate Occlusion (CIAO ) glassesParticipants wear 3-hour CIAO therapy |
| Observation | No intervention | –No intervention, just observation |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (23 listed)
- Age 3 to 11 years old
- 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 20/40 (0.3 logMAR) or better on ATS HOTV for ages 3 - 5 and 20/25 (0.1 logMAR) or better on ATS HOTV for ages 6 - 11
- No hyperopia greater than +3.50 D spherical equivalent in either eye
Key exclusion criteria (6 listed)
- Only phoria at both distance and near
- Prior non-surgical treatment for IXT other than refractive correction (e.g., vergence therapy, occlusion, vision therapy/orthoptics, or deliberate over-minus with spectacles more than 0.50D)
- Previous amblyopia treatment other than refractive correction within 1 year
- Vision therapy/orthoptics for any reason within the last year
- Interocular visual acuity difference more than 0.2 logMAR (2 lines on ATS HOTV for patients 3 to < 7 years old or 10 letters on E-ETDRS for patients ≥ 7 years old)
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 |
|---|---|---|
| Controlled Intermittent Alternate Occlusion (CIAO ) glassesMonitored CIAO therapy glasses | Device | Monitored CIAO therapy |
Primary outcome
Control of the exodeviation assessment (scaled 1-5)
Time frame: 3-month
Intermittent Exotropia Control Scale (1-5) 5 = Constant exotropia 4 = Exotropia > 50% of the 30-second period before dissociation 3 = Exotropia < 50% of the 30-second period before dissociation 2 = No exotropia unless dissociated, recovers in > 5 seconds 1 = No exotropia unless dissociated, recovers in 1-5 seconds 0 = No exotropia unless dissociated, recovers in < 1 second (phoria)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Intermittent Exotropia, run by Salus 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 23 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingyun Wang, PhD (215-780-1376, jwang@salus.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control of the exodeviation assessment (scaled 1-5) (time frame: 3-month). 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 5 Apr 2019.