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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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The study objective is to assess changes in corneal sensation and dry eye signs and symptoms following cataract extraction/femtosecond arcuate relaxing incisions.
Our clinical hypothesis is to determine if a combination of cataract surgery and femtosecond arcuate relaxing incisions lead to a reduction in corneal sensation and the onset or worsening of dry eye signs and symptoms.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Corneal Sensitivity Testing | Subject lies supine with the test line of the Cochet-Bonnet Aesthesiometer suspended over the cornea to measure the sensation of touch on the eye. Testing is done in a standard manner by an experienced operator. | Change from Screening to Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Disease Index (OSDI) | Subject questionnaire | Change from Screening to Month 3 |
| Subject Dry Eye Questionnaire | Subject questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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Private Practice
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthlamic Consultants of Long Island - Rockville Centre | Recruiting | Rockville Centre | New York | 11570 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 19, 2018 | |
| Reset | Apr 5, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 19, 2018 | Apr 5, 2019 |
| ID | Term |
|---|---|
| D002386 | Cataract |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
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| Change from Screening to Month 3 |
| Artificial Tear Use | Subject questionnaire | Change from Screening to Month 3 |
| Corneal and Conjunctival Staining | Clinical assessment of Dry Eye severity on the cornea via the use of fluorescein dye and on the conjunctiva via the use of lissamine green dye. | Change from Screening to Month 3 |
| Tear Break Up Time (TBUT) with Biomicroscopy | Clinical assessment of Dry Eye severity via Biomicroscopy with fluorescein dye | Change from Screening to Month 3 |
| Best Corrected Visual Acuity (BCVA) | Best Corrected Visual Acuity via eye chart examination | Change from Screening to Month 3 |
| Intraocular Pressure (IOP) | Intraocular pressure via slit lamp examination | Change from Screening to Month 3 |