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This is a 3-visit, single site, observational clinical study to evaluate the characterization of the central and peripheral wavefront aberration profiles in pediatric myopic subjects.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Diagnostic Test | No test articles will be used in the study. However, while taking measurements, the subject's eye will be exposed to light or light flashes that are about the same or lesser intensity than those in a routine eye exam in an eye care provider's office. |
| Measure | Description | Time Frame |
|---|---|---|
| Central aberration profile of pediatric myopia population under cycloplegic conditions for distance | Assessment of central aberration profile of pediatric myopia population under cycloplegic conditions for distance (target at 4m) viewing conditions. | up to day 26 from Visit 1 |
| Peripheral aberration profile of pediatric myopia population under cycloplegic conditions for distance | Assessment of peripheral aberration profile of pediatric myopia population under cycloplegic conditions for distance (target at 4m) viewing conditions. | up to day 26 from Visit 1 |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
The subject must:
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
The subject must not:
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Healthy male and female non-contact lens wearing subjects within ages 6 to 17 years will be recruited. Subjects enrolled in this study will be myopic. Approximately half the number of subjects will be under 10 years of age.
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Vision Care, Inc. Clinical Trial | Johnson & Johnson Vision Care, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Houston College of Optometry - J. Armistead Bldg Room 2195 | Houston | Texas | 77204 | United States |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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