Infantile EsotropiaNCT00310960
An Observational Study of Infantile, Acquired Non-accommodative, and Acquired Partially-accommodative Esotropia
An observational study of Infantile Esotropia and Acquired Non-accommodative Esotropia, run by Jaeb Center for Health Research at 1 site in United States.
Trial summary
The purpose of this study is to: To estimate the duration of misalignment by age at presentation in infantile esotropia (infantile ET), acquired non-accommodative esotropia (ANAET) and acquired partially accommodative esotropia (APAET). Read more about this study
- Who is it for?
- Ages Up to 4 years
- Conditions the study is for
- Infantile Esotropia, Acquired Non-accommodative Esotropia, Acquired Partially Accommodative Esotropia
- How many people
- 293 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to May 2008
- Phase
- Observational
- 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 Up to 4 years
- All sexes
- No healthy volunteers
- Child
Study population: Community sample
Who may be able to join
- For infantile ET:
- Less than 12 months old
- Duration of esotropia less than 6 months by best estimate (photos, parent history, physician records)
- A constant or variable esotropia
- Onset before six months of age
- Measuring >10 PD by Alternate Prism and Cover Test (APCT) in the primary position at distance fixation on an accommodative target
Show all 30Show fewer
- Gestational age > 34 weeks
- Birth weight > 1500 grams
- For ANAET:
- 6 months to <5 years old
- Duration of esotropia less than 6 months by best estimate (photos, parent history, physician records)
- A constant or variable esotropia
- Onset after six months of age
- Angle decreases less than 10 prism diopters (PD) by Alternate Prism and Cover Test (APCT) in the primary position at distance fixation with correction
- Residual angle measures >10 PD by Simultaneous Prism and Cover Test (SPCT) in the primary position at distance fixation
- For patients who have significant refractive error, full hyperopic correction determined with cycloplegia must have been worn for at least 2 weeks.
- For patients who do not have significant refractive error, whether to prescribe spectacles is at investigator discretion, however, if the investigator elects to prescribe spectacles, the full hyperopic correction determined with cycloplegia must have been worn for at least 2 weeks
- Gestational age > 34 weeks
- Birth weight > 1500 grams
- For APAET:
- Onset after six months of age
- 6 months to <5 years old
- Duration of esotropia less than 6 months by best estimate (photos, parent history, physician records)
- Angle decreases 10 prism diopters (PD) or more by Alternate Prism and Cover Test (APCT) in the primary position at distance fixation with correction
- A constant or variable esotropia
- Residual angle measures >10 PD by Simultaneous Prism and Cover Test (SPCT) in the primary position at distance fixation
- For patients who have significant refractive error, full hyperopic correction determined with cycloplegia must have been worn for at least 2 weeks.
- For patients who do not have significant refractive error, whether to prescribe spectacles is at investigator discretion, however, if the investigator elects to prescribe spectacles, the full hyperopic correction determined with cycloplegia must have been worn for at least 2 weeks
- Gestational age > 34 weeks
- Birth weight > 1500 grams
Who cannot join
- For infantile ET:
- prior spectacle wear
- For infantile ET,ANAET,APAET:
- Atropine use within the last two weeks
- History of CNS disease (e.g. intraventricular hemorrhage (IVH), PVL, meningitis, developmental abnormalities of the brain, hydrocephalus, cerebral palsy, hypoxic ischemic encephalopathy)
- Significant developmental delay in the investigator's judgment (isolated speech delay excepted)
Show all 10Show fewer
- Limitation of abduction consistent with paralytic or restrictive myopathy (minor limitation of abduction due to cross fixation is acceptable)
- Craniofacial malformation affecting the orbits
- Prior extraocular muscle surgery or intraocular surgery
- Structural ocular abnormalities (e.g. media opacity, optic atrophy, optic nerve hypoplasia, retinal detachment)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
About this study
The purpose of this study is to:
- To estimate the duration of misalignment by age at presentation in infantile esotropia (infantile ET), acquired non-accommodative esotropia (ANAET) and acquired partially accommodative esotropia (APAET).
- To determine the proportion of patients with angle instability in infantile ET, ANAET and APAET by length of follow-up.
Read the detailed description
Approximately one third of infants with infantile esotropia (infantile ET) and a similar proportion of children with acquired non-accommodative esotropia (ANAET) will have an increasing angle within the first few months of their initial examination. In approximately two thirds of patients, the angle of misalignment remains stable and in a small proportion, the angle of esotropia decreases. The changing angle of misalignment in a significant proportion of children with esotropia raises an important question regarding the timing of surgical management of these children: should surgery be undertaken immediately or delayed until the alignment stabilizes? Early surgery may improve sensory outcomes; delayed surgery may improve surgical dosing accuracy and motor outcomes.
Children with acquired partially accommodative esotropia (APAET) may differ from those with infantile ET and ANAET in that they tend to present at an older age, are more likely to preserve high-grade stereopsis with appropriate treatment, require surgical intervention less frequently, and have more substantial hyperopic refractive errors. Little is known regarding early angle stability in this group of patients following correction of their refractive errors.
Although there is a need for a randomized trial to address the issue of timing of surgery in infantile ET, APAET, and ANAET, prior to designing such a trial, high-quality preliminary data are needed. We propose a multi-center observational study to 1) determine the duration of misalignment in infantile ET, ANAET, and APAET at study enrollment, 2) to prospectively establish the proportion of patients with angle instability in infantile ET, ANAET, and APAET, and 3) to determine recruitment potential for a randomized trial. These data will be crucial for sample size calculations for the eventual randomized trial, and will help further define the clinical characteristics of these conditions.
A concurrent and nested ancillary study will be conducted at selected centers to collect test-retest data on alignment measurements for estimating the amount of measurement variability. These test-retest data will be used to define a change in angle alignment that exceeds an amount which could reasonably be due to measurement error, which will be used in evaluating the proportion of patients with angle instability in the current study.
Eligible patients with infantile ET will be consented and enrolled at their initial visit. Infantile ET patients who need spectacles will be prescribed spectacles and will return for an Infantile ET Spectacle Baseline Visit 2 weeks later.
ANAET and APAET patients who present wearing spectacles with appropriate correction for at least 2 weeks will be consented and enrolled into the study at that initial visit.
For ANAET and APAET patients who present not wearing spectacles:
- Patients who do not need spectacles will be consented and enrolled into the study at that initial visit.
- Patients who need spectacles are prescribed appropriate correction if the investigator intends to offer the patient enrollment at a later date. Patients are asked to return after wearing the new spectacles 2-6 weeks, at which time they may be consented and enrolled into the study.
Sample Size: The study will enroll 100 patients for each of the three esotropia types of infantile ET, ANAET, and APAET, for a total of 300 patients.
- Conditions
- Infantile Esotropia, Acquired Non-accommodative Esotropia, Acquired Partially Accommodative Esotropia
- Keywords
- infantile esotropia, acquired non-accommodative esotropia, acquired partially accommodative esotropia
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of angle instability
Measured: 18 weeks
Estimation of misalignment
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startJun 2004
- Primary completionOct 2007
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile EsotropiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Stephen P. Christiansen, M.D., Study chair, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310960
- Sponsor's protocol ID
- NEI-102
- Other IDs
- 2U10EY011751, 5U10EY011751
- Status last verified
- Aug 2011
- First submitted
- 3 Apr 2006
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Infantile, Acquired Non-accommodative, and Acquired Partially-accommodative Esotropia
- ClinicalTrials.gov ID
- NCT00310960
- Acronym / sponsor ID
- NEI-102
- Conditions
- Infantile Esotropia, Acquired Non-accommodative Esotropia, Acquired Partially Accommodative Esotropia
- Keywords
- infantile esotropia, acquired non-accommodative esotropia, acquired partially accommodative esotropia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Jun 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 5 Apr 2006 (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.
The purpose of this study is to:
- To estimate the duration of misalignment by age at presentation in infantile esotropia (infantile ET), acquired non-accommodative esotropia (ANAET) and acquired partially accommodative esotropia (APAET).
- To determine the proportion of patients with angle instability in infantile ET, ANAET and APAET by length of follow-up.
Detailed description
Approximately one third of infants with infantile esotropia (infantile ET) and a similar proportion of children with acquired non-accommodative esotropia (ANAET) will have an increasing angle within the first few months of their initial examination. In approximately two thirds of patients, the angle of misalignment remains stable and in a small proportion, the angle of esotropia decreases. The changing angle of misalignment in a significant proportion of children with esotropia raises an important question regarding the timing of surgical management of these children: should surgery be undertaken immediately or delayed until the alignment stabilizes? Early surgery may improve sensory outcomes; delayed surgery may improve surgical dosing accuracy and motor outcomes.
Children with acquired partially accommodative esotropia (APAET) may differ from those with infantile ET and ANAET in that they tend to present at an older age, are more likely to preserve high-grade stereopsis with appropriate treatment, require surgical intervention less frequently, and have more substantial hyperopic refractive errors. Little is known regarding early angle stability in this group of patients following correction of their refractive errors.
Although there is a need for a randomized trial to address the issue of timing of surgery in infantile ET, APAET, and ANAET, prior to designing such a trial, high-quality preliminary data are needed. We propose a multi-center observational study to 1) determine the duration of misalignment in infantile ET, ANAET, and APAET at study enrollment, 2) to prospectively establish the proportion of patients with angle instability in infantile ET, ANAET, and APAET, and 3) to determine recruitment potential for a randomized trial. These data will be crucial for sample size calculations for the eventual randomized trial, and will help further define the clinical characteristics of these conditions.
A concurrent and nested ancillary study will be conducted at selected centers to collect test-retest data on alignment measurements for estimating the amount of measurement variability. These test-retest data will be used to define a change in angle alignment that exceeds an amount which could reasonably be due to measurement error, which will be used in evaluating the proportion of patients with angle instability in the current study.
Eligible patients with infantile ET will be consented and enrolled at their initial visit. Infantile ET patients who need spectacles will be prescribed spectacles and will return for an Infantile ET Spectacle Baseline Visit 2 weeks later.
ANAET and APAET patients who present wearing spectacles with appropriate correction for at least 2 weeks will be consented and enrolled into the study at that initial visit.
For ANAET and APAET patients who present not wearing spectacles:
- Patients who do not need spectacles will be consented and enrolled into the study at that initial visit.
- Patients who need spectacles are prescribed appropriate correction if the investigator intends to offer the patient enrollment at a later date. Patients are asked to return after wearing the new spectacles 2-6 weeks, at which time they may be consented and enrolled into the study.
Sample Size: The study will enroll 100 patients for each of the three esotropia types of infantile ET, ANAET, and APAET, for a total of 300 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Community sample
Key inclusion criteria (30 listed)
- Less than 12 months old
- Duration of esotropia less than 6 months by best estimate (photos, parent history, physician records)
- A constant or variable esotropia
- Onset before six months of age
- Measuring >10 PD by Alternate Prism and Cover Test (APCT) in the primary position at distance fixation on an accommodative target
Key exclusion criteria (10 listed)
- prior spectacle wear
- Atropine use within the last two weeks
- History of CNS disease (e.g. intraventricular hemorrhage (IVH), PVL, meningitis, developmental abnormalities of the brain, hydrocephalus, cerebral palsy, hypoxic ischemic encephalopathy)
- Significant developmental delay in the investigator's judgment (isolated speech delay excepted)
- Limitation of abduction consistent with paralytic or restrictive myopathy (minor limitation of abduction due to cross fixation is acceptable)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determination of angle instability
Time frame: 18 weeks
Estimation of misalignment
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2011.
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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.
Stephen P. Christiansen, M.D. study chair
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infantile Esotropia and Acquired Non-accommodative Esotropia, run by Jaeb Center for Health Research 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 30 inclusion and 10 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: finished, as of the sponsor's last update on 2 Sep 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determination of angle instability (time frame: 18 weeks). The study lists 2 primary outcomes in all. 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 2 Sep 2011.