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The purpose of this study is to evaluate the accuracy and repeatability of an individually validated prototype autorefractor designed to be mounted on a surgical microscope.
The purpose of this study is to evaluate the accuracy and repeatability of an individually validated prototype autorefractor designed to be mounted on a surgical microscope. The goal is to evaluate 20 subjects with both the investigational instrument followed by a commercially available instrument.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative Autorefractor IAR-1 | Experimental | This is a auto refractor mounted on an operating microscope. |
|
| Hartmann-Shack Auto Refractor | Active Comparator | The Hartmann-Shack type auto refractor used with the subject sitting upright in front of the instrument. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative Autorefractor IAR-1 | Device | This is an auto-refractor mounted on an operating microscope and used with the subject in a supine position |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the accuracy and repeatability of the Test device compared to the Control | Comparative auto refractor device measurement variation is defined as +/-0.25 Diopters | 1 Hour |
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Inclusion Criteria:
Be at least 18 years of age as of the date of evaluation for the study.
Have:
Be willing and able to adhere to the instructions set forth in this protocol and able to participate in all scheduled evaluations.
Be in good general health, based on his/her knowledge.
Have a refractive error within the range of -10.00 to +30.00 Diopter sphere and up to 5.00 Diopter of refractive cylinder .
Have manifest refraction (BCVA) Snellen visual acuities (VA) equal to or better than 20/25 in each eye. -
Exclusion Criteria:
Subjects may not be enrolled in this study if any of the following apply: The subject is/has:
Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining > Grade 2 Pterygium Corneal scars within the visual axis Neovascularization or ghost vessels > 1.0 mm in from the limbus Giant papillary conjunctivitis (GPC) of > Grade 2 Anterior uveitis or iritis Seborrheic eczema, seborrheic conjunctivitis or blepharitis
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| Name | Affiliation | Role |
|---|---|---|
| Gregg Berdy, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 4, 2018 | |
| Reset | Jul 2, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 4, 2018 | Jul 2, 2018 |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Hartmann-Shack Auto Refractor | Device | Standard auto-refractor used with subject sitting upright in front of the instrument. |
|