Early Versus Delayed Surgery for Infantile Esotropia - Full Text View

Sponsor:	The Hospital for Sick Children
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT01166503

Purpose

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).

Condition	Intervention	Phase
Esotropia	Procedure: mVEP Testing Procedure: Stereoacuity Testing Procedure: Optokinetic nystagmus testing Procedure: Motion detection testing Procedure: Motion discrimination testing	Phase I Phase II

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Early Versus Delayed Surgery for Infantile Esotropia: A Clinical Evaluation of Sensory and Motor Outcomes

Resource links provided by NLM:

Genetics Home Reference related topics: progressive external ophthalmoplegia

U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:

Motion visual evoked potential (mVEPs) asymmetry [ Time Frame: at age 2 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
This measures the level of 3D depth perception.
Optokinetic nystagmus (OKN) asymmetry [ Time Frame: at age 5 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Motion perception will be tested using two tasks: motion detection (at age 2 and 5 years) and motion discrimination (at age 5 years).

Estimated Enrollment:	60
Study Start Date:	May 2004
Estimated Study Completion Date:	May 2016
Estimated Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.	Procedure: mVEP Testing 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. Procedure: Stereoacuity Testing Subjects will have their 3D perception measured using standard clinical stereo tests (Randot, Lang, Titmus). Procedure: Optokinetic nystagmus testing 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. Procedure: Motion detection testing 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). Procedure: Motion discrimination testing 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).
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.	Procedure: mVEP Testing 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. Procedure: Stereoacuity Testing Subjects will have their 3D perception measured using standard clinical stereo tests (Randot, Lang, Titmus). Procedure: Optokinetic nystagmus testing 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. Procedure: Motion detection testing 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). Procedure: Motion discrimination testing 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).

Groups/Cohorts

Assigned Interventions

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.

Procedure: mVEP Testing

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.

Procedure: Stereoacuity Testing

Subjects will have their 3D perception measured using standard clinical stereo tests (Randot, Lang, Titmus).

Procedure: Optokinetic nystagmus testing

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.

Procedure: Motion detection testing

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).

Procedure: Motion discrimination testing

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).

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.

Procedure: mVEP Testing

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.

Procedure: Stereoacuity Testing

Subjects will have their 3D perception measured using standard clinical stereo tests (Randot, Lang, Titmus).

Procedure: Optokinetic nystagmus testing

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.

Procedure: Motion detection testing

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).

Procedure: Motion discrimination testing

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).

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.

Eligibility

Ages Eligible for Study:	3 Months to 23 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

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.

Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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;
manifest nystagmus or head bobbing;
prior eye muscle surgery;
prior treatment of amblyopia or spectacle correction for refractive errors;
presence of structural ocular anomalies.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166503

Contacts

Contact: Linda Colpa, O.C.(C)

416-813-7654 ext 28104

linda.colpa@sickkids.ca

Locations

Canada, Ontario
The Hospital for Sick Children	Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Linda Colpa, O.C.(C) (416) - 813 - 7654 ext 28104 linda.colpa@sickkids.ca
Principal Investigator: Agnes Wong, MD

Sponsors and Collaborators

The Hospital for Sick Children

Investigators

Principal Investigator:

Agnes Wong, MD

The Hospital for Sick Children, Toronto Canada

More Information

No publications provided

Responsible Party:	Dr. Agnes Wong/ Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT01166503 History of Changes
Other Study ID Numbers:	1000005134
Study First Received:	July 19, 2010
Last Updated:	July 19, 2010
Health Authority:	Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:

pediatrics
Esotropia
Surgery

Additional relevant MeSH terms:

Esotropia
Strabismus
Ocular Motility Disorders

Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases

ClinicalTrials.gov processed this record on February 09, 2012