Apioc Toric/Spherical Single Vision Contact Lens
Study Details
Study Description
Brief Summary
The Lentechs Apioc-S and Apioc-A contact lenses are made in an FDA-approved contact lens material indicated for single-vision and astigmatism. The novel lens design has a lenticular portion which is thicker than the optical portion of the lens. When applied to the eye, it is oriented in a superior position. Unlike contact lenses currently on the market, this innovative design improves lens stability by preventing lens rotation, and may improve tear flow behind the lens.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Outcome Measures
Primary Outcome Measures
- Visual Acuity [30 days]
LogMAR distance visual acuity
Secondary Outcome Measures
- Comfort [30 days]
Contact Lens Dry Eye Questionnaire-8, scale range 0 minimum (better outcome) to 38 maximum (worse outcome).
- Rotational Stability of Apioc-A [30 days]
Clockwise or counter-clockwise rotation
Eligibility Criteria
Criteria
Inclusion Criteria:
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The subject must provide written informed consent.
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The subject must appear willing and able to adhere to the instructions set forth in this protocol.
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At least 18 years of age and no more than 35 years of age.
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≤ 4.00 D of corneal astigmatism.
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≤ 4.00 D of refractive astigmatism.
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Refractive error range +20.00 DS to -20.00 DS
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Flat and steep keratometry readings within 40 to 50D.
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Clear, healthy corneas with no irregular astigmatism.
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Normal, healthy conjunctiva in both eyes.
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Free of active ocular disease. Refractive error is permitted.
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Be a current or former (within the last 12 months) contact lens wearer.
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Best-corrected near and distance visual acuity better than or equal to 20/25.
Exclusion Criteria:
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Irregular corneal astigmatism.
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Presbyopia
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Corneal scarring unless off line-of-site and well healed.
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Pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear.
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Recent use of any ocular pharmaceutical treatments, including daily artificial tears, in the two weeks prior to the examination. Use of artificial tears less than 3 drops per week is permitted.
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Systemic disease that would interfere with contact lens wear.
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Currently pregnant or lactating (by self-report).
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History of strabismus or eye movement disorder.
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Active allergies that may inhibit contact lens wear.
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Upper eyelid margin at or above the superior limbus.
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History of ocular or lid surgery.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Quinn Foster & Associates | Athens | Ohio | United States | 45701 |
2 | EyeCare Professionals of Powell | Powell | Ohio | United States | 43065 |
Sponsors and Collaborators
- Lentechs, LLC
Investigators
- Principal Investigator: Thomas G Quinn, OD, MS, FAAO, Drs. Quinn, Foster & Associates
- Principal Investigator: Jason R Miller, OD, MBA, Eyecare Professionals of Powell
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LEN004