EsotropiaNCT01166503
Early Versus Delayed Surgery for Infantile Esotropia
An observational study of Esotropia, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The goal of this study is to determine whether corrective surgery done earlier than the current standard can better improve the visual and eye movement deficits in children with infantile esotropia (crossed eyes in infancy). Read more about this study
- Who is it for?
- Ages 3 to 23 months
- Conditions the study is for
- Esotropia
- What is being tested?
- mVEP Testing, Stereoacuity Testing and Optokinetic nystagmus testing
- Type of treatment
- Surgery or procedure
- How many people
- 71 participants
- Where
- 1 siteCanada
- Study dates
- May 2004to 26 Apr 2018
- 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 3 to 23 months
- All sexes
- No healthy volunteers
- Child
Study population: Patients with infantile esotropia will be enrolled from The Hospital for Sick Children in Toronto. Infants with characteristics that indicate low likelihood of spontaneous resolution will be studied.
Who may be able to join
- onset of esotropia after 10 weeks of age;
- constant esotropia ≥ 20° (40 prism diopter or PD) at near (1/3 m) on two examinations, separated by 2-4 weeks; and
- refractive error ≤ +3.00 diopters (far-sightedness).
Who cannot join
- gestational age < 34 weeks;
- birth weight ≤ 1500 g;
- ventilator treatment in the newborn period;
- history of meningitis or other major medical event;
- developmental delay;
- incomitant or paralytic strabismus;
Show all 10Show fewer
- manifest nystagmus or head bobbing;
- prior eye muscle surgery;
- prior treatment of amblyopia or spectacle correction for refractive errors;
- presence of structural ocular anomalies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Versus Delayed Surgery for Infantile Esotropia: A Clinical Evaluation of Sensory and Motor Outcomes
The goal of this study is to determine whether corrective surgery done earlier than the current standard can better improve the visual and eye movement deficits in children with infantile esotropia (crossed eyes in infancy).
Read the detailed description
While there is a uniform agreement among pediatric ophthalmologists that most infantile esotropia requires surgical correction, the proper timing of surgery is controversial. In North America, the typical age at surgery ranges from 11-18 months. Unfortunately, despite successful surgical realignment of the eyes, the sensory and eye movement deficits often persist. Recently, some pediatric ophthalmologists have advocated earlier surgery. The rationale for early surgery stems from animal and human research showing that early realignment of the eyes within an early critical period allows normal development of the sensory and eye movement systems.
- Conditions
- Esotropia
- Being tested
- mVEP Testing, Stereoacuity Testing, Optokinetic nystagmus testing, Motion detection testing, Motion discrimination testing
- Keywords
- pediatrics, Esotropia, Surgery
- Medical subject headings
- Esotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mVEP TestingProcedure or surgery
Five small sensors are placed on the head which record the brain's response to moving stripes that are displayed on a computer screen. Each eye is tested while the other eye is patched. Each recording trial lasts about 10 seconds, and several trials are done for each eye.
Stereoacuity TestingProcedure or surgery
Subjects will have their 3D perception measured using standard clinical stereo tests (Randot, Lang, Titmus).
Optokinetic nystagmus testingProcedure or surgery
Subjects will be asked to view a screen with vertical stripes moving in both leftward and rightward directions while their eye movements are recorded using a remote video-based eye tracker.
Motion detection testingProcedure or surgery
Subjects will view a computer screen that has two panels of dots on them. The subject will be required to pick which panel has a section of dots that are moving in a specific direction (ie. nasalward/temporalward).
Motion discrimination testingProcedure or surgery
Subjects will view a computer screen that has two panels of randomly moving dots on them. The subject will be required to pick which panel has a section of dots that are moving in a specific direction (ie. nasalward/temporalward).
| Study group | Role | What they receive |
|---|---|---|
| Early Surgery | This group will be made up of subjects whose parents choose to have them undergo corrective surgery at or before age 11 months. Receives: Procedure: mVEP Testing; Procedure: Stereoacuity Testing; Procedure: Optokinetic nystagmus testing; Procedure: Motion detection testing; Procedure: Motion discrimination testing | |
| Standard Surgery | This group will be made up of subjects who present after age 11 months or whose parents choose to have them undergo corrective surgery between 11-18 months. Receives: Procedure: mVEP Testing; Procedure: Stereoacuity Testing; Procedure: Optokinetic nystagmus testing; Procedure: Motion detection testing; Procedure: Motion discrimination testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motion visual evoked potential (mVEPs) asymmetry
mVEP measures the perception of nasalward and temporalward motion for each eye at the cortical level. A nasal bias index (NBI) is calculated, which will show whether subjects perceive motion better for one direction over the other.
Measured: at age 2 years
Stereopsis
This measures the level of 3D depth perception.
Measured: at 2 and 5 years of age
Optokinetic nystagmus (OKN) asymmetry
OKN is measured in both the nasalward and temporalward directions for each eye. From this a nasal bias index (NBI) is calculated, which will show whether subjects perceive motion better in one direction or the other.
Measured: at age 5 years
Global Motion Perception
Motion perception will be tested using two tasks: motion detection (at age 2 and 5 years) and motion discrimination (at age 5 years).
Measured: at 2 and 5 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startMay 2004
- Primary completion2 Apr 2018
- Study completion26 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnes Wong, The Hospital for Sick Children
- Investigators
- Agnes Wong, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166503
- Sponsor's protocol ID
- 1000005134
- Status last verified
- Jun 2018
- First submitted
- 19 Jul 2010
- Last updated
- 12 Jun 2018
- 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 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Delayed Surgery for Infantile Esotropia: A Clinical Evaluation of Sensory and Motor Outcomes
- ClinicalTrials.gov ID
- NCT01166503
- Acronym / sponsor ID
- 1000005134
- Conditions
- Esotropia
- Keywords
- pediatrics, Esotropia, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- 2 Apr 2018 (actual)
- Study completion
- 26 Apr 2018 (actual)
- First posted
- 21 Jul 2010 (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 goal of this study is to determine whether corrective surgery done earlier than the current standard can better improve the visual and eye movement deficits in children with infantile esotropia (crossed eyes in infancy).
Detailed description
While there is a uniform agreement among pediatric ophthalmologists that most infantile esotropia requires surgical correction, the proper timing of surgery is controversial. In North America, the typical age at surgery ranges from 11-18 months. Unfortunately, despite successful surgical realignment of the eyes, the sensory and eye movement deficits often persist. Recently, some pediatric ophthalmologists have advocated earlier surgery. The rationale for early surgery stems from animal and human research showing that early realignment of the eyes within an early critical period allows normal development of the sensory and eye movement systems.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Surgery | – | Procedure: mVEP Testing, Procedure: Stereoacuity Testing, Procedure: Optokinetic nystagmus testing, Procedure: Motion detection testing, Procedure: Motion discrimination testingThis group will be made up of subjects whose parents choose to have them undergo corrective surgery at or before age 11 months. |
| Standard Surgery | – | Procedure: mVEP Testing, Procedure: Stereoacuity Testing, Procedure: Optokinetic nystagmus testing, Procedure: Motion detection testing, Procedure: Motion discrimination testingThis group will be made up of subjects who present after age 11 months or whose parents choose to have them undergo corrective surgery between 11-18 months. |
Who may qualify
- Ages
- 3 to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with infantile esotropia will be enrolled from The Hospital for Sick Children in Toronto. Infants with characteristics that indicate low likelihood of spontaneous resolution will be studied.
Key inclusion criteria (3 listed)
- onset of esotropia after 10 weeks of age;
- constant esotropia ≥ 20° (40 prism diopter or PD) at near (1/3 m) on two examinations, separated by 2-4 weeks; and
- refractive error ≤ +3.00 diopters (far-sightedness).
Key exclusion criteria (10 listed)
- gestational age < 34 weeks;
- birth weight ≤ 1500 g;
- ventilator treatment in the newborn period;
- history of meningitis or other major medical event;
- developmental delay;
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 |
|---|---|---|
| mVEP TestingFive small sensors are placed on the head which record the brain's response to moving stripes that are displayed on a computer screen. Each eye is tested while the other eye is patched. Each recording trial lasts about 10 seconds, and several trials are done for each eye. | Procedure or surgery | Early Surgery, Standard Surgery |
| Stereoacuity TestingSubjects will have their 3D perception measured using standard clinical stereo tests (Randot, Lang, Titmus). | Procedure or surgery | Early Surgery, Standard Surgery |
| Optokinetic nystagmus testingSubjects will be asked to view a screen with vertical stripes moving in both leftward and rightward directions while their eye movements are recorded using a remote video-based eye tracker. | Procedure or surgery | Early Surgery, Standard Surgery |
| Motion detection testingSubjects will view a computer screen that has two panels of dots on them. The subject will be required to pick which panel has a section of dots that are moving in a specific direction (ie. nasalward/temporalward). | Procedure or surgery | Early Surgery, Standard Surgery |
| Motion discrimination testingSubjects will view a computer screen that has two panels of randomly moving dots on them. The subject will be required to pick which panel has a section of dots that are moving in a specific direction (ie. nasalward/temporalward). | Procedure or surgery | Early Surgery, Standard Surgery |
Primary outcome
Motion visual evoked potential (mVEPs) asymmetry
Time frame: at age 2 years
mVEP measures the perception of nasalward and temporalward motion for each eye at the cortical level. A nasal bias index (NBI) is calculated, which will show whether subjects perceive motion better for one direction over the other.
Stereopsis
Time frame: at 2 and 5 years of age
This measures the level of 3D depth perception.
Optokinetic nystagmus (OKN) asymmetry
Time frame: at age 5 years
OKN is measured in both the nasalward and temporalward directions for each eye. From this a nasal bias index (NBI) is calculated, which will show whether subjects perceive motion better in one direction or the other.
Global Motion Perception
Time frame: at 2 and 5 years of age
Motion perception will be tested using two tasks: motion detection (at age 2 and 5 years) and motion discrimination (at age 5 years).
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 12 Jun 2018.
- 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.
Agnes Wong, MD principal investigator
The Hospital for Sick Children, Toronto Canada
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 Esotropia, run by The Hospital for Sick Children at 1 site in Canada.
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 3 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 12 Jun 2018. 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 Canada. 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?
Motion visual evoked potential (mVEPs) asymmetry (time frame: at age 2 years). The study lists 4 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 12 Jun 2018.