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This is a unilateral, non-interventional study. Each subject will be unilaterally measured with the WAM-5500 autorefractor by 3 testers. All measurements will be made on the right eye only.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental | Diagnostic Test | Eligible subjects with sphere component of the subjective spherocylindrical refraction between +1.50 to -6.00D (inclusive) and 2.00D or less astigmatism in the right eye will be unilaterally measured with the WAM-5500 autorefractor by 3 testers. |
| Measure | Description | Time Frame |
|---|---|---|
| Central (on-axis) cycloplegic auto-refraction | Central (on-axis) cycloplegic auto-refraction will be measured to evaluate the intra-visit repeatability, inter-visit repeatability, and reproducibility of central refractive error measurements with the Grand Seiko WAM-5500. | Up to 10-day follow-up visit |
| Peripheral (10° off-axis on the temporal retina) cycloplegic auto-refraction | Peripheral cycloplegic auto-refraction will be measured to evaluate the intra-visit repeatability, inter-visit repeatability, and reproducibility of peripheral refractive error measurements with the Grand Seiko WAM-5500 at 10° temporal retina. | Up to 10-day follow-up visit |
| Peripheral (20° off-axis on the temporal retina) cycloplegic auto-refraction | Peripheral cycloplegic auto-refraction will be measured to evaluate the intra-visit repeatability, inter-visit repeatability, and reproducibility of peripheral refractive error measurements with the Grand Seiko WAM-5500 at 20° temporal retina. | Up to 10-day follow-up visit |
| Peripheral (30° off-axis on the temporal retina) cycloplegic auto-refraction | Peripheral cycloplegic auto-refraction will be measured to evaluate the intra-visit repeatability, inter-visit repeatability, and reproducibility of peripheral refractive error measurements with the Grand Seiko WAM-5500 at 30° temporal retina. | Up to 10-day follow-up visit |
| Peripheral (10° off-axis on the nasal retina) cycloplegic auto-refraction | Peripheral cycloplegic auto-refraction will be measured to evaluate the intra-visit repeatability, inter-visit repeatability, and reproducibility of peripheral refractive error measurements with the Grand Seiko WAM-5500 at 10° nasal retina. | Up to 10-day follow-up visit |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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Healthy male and female subjects between 18 and 50 years of age (inclusive) of any ethnicity with sphere component of the subjective spherocylindrical refraction between +1.50 to -6.00D (inclusive) and 2.00D or less astigmatism in the right eye.
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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 |
|---|---|---|---|---|---|---|
| VRC | Jacksonville | Florida | 32256 | 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 |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Peripheral (20° off-axis on the nasal retina) cycloplegic auto-refraction: | Peripheral cycloplegic auto-refraction will be measured to evaluate the intra-visit repeatability, inter-visit repeatability, and reproducibility of peripheral refractive error measurements with the Grand Seiko WAM-5500 at 20° nasal retina. | Up to 10-day follow-up visit |
| Peripheral (30° off-axis on the nasal retina) cycloplegic auto-refraction | Peripheral cycloplegic auto-refraction will be measured to evaluate the intra-visit repeatability, inter-visit repeatability, and reproducibility of peripheral refractive error measurements with the Grand Seiko WAM-5500 at 30° nasal retina. | Up to 10-day follow-up visit |