Status:
COMPLETED
APIOC for Presbyopia and APIOC for Presbyopia With Astigmatism
Lead Sponsor:
Lentechs, LLC
Conditions:
Presbyopia
Myopia
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief Summary
Vision and comfort, both objective and subjective, will be assessed for single vision contact lens wearers for either the APIOC™ for Presbyopia or the APIOC™ for Presbyopia Astigmatism contact lenses.
Eligibility Criteria
Inclusion
- The subject must provide written informed consent.
- The subject must appear willing and able to adhere to the instructions set forth in this protocol.
- At least 40 years of age and no more than 70 years of age.
- ≤ 4.00 D of corneal astigmatism.
- ≤ 2.50 D of refractive astigmatism.
- Refractive error range +4.00 DS to -6.00 DS
- Require a reading addition (bifocal) of at least 0.75 D
- Flat and steep keratometry readings within 40 to 48 D.
- Clear, healthy corneas with no irregular astigmatism.
- Normal, healthy conjunctiva in both eyes.
- Free of active ocular disease. Refractive error and presbyopia are permitted.
- Be a current or former (within the last 3 years) contact lens wearer.
- Best-corrected near and distance visual acuity better than or equal to 20/25.
Exclusion
- Irregular corneal astigmatism.
- Corneal scarring unless off line-of-site and well healed.
- Pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear.
- Recent use of any ocular pharmaceutical treatments, including daily artificial tears, in the two weeks prior to the examination. Occasional artificial tear use is permitted.
- Systemic disease that would interfere with contact lens wear.
- Currently pregnant or lactating (by self-report).
- History of strabismus or eye movement disorder, including exophoria at near that is 4 D or greater than at far, and a receded near point of convergence break that is 6 cm or greater.
- Active allergies that may inhibit contact lens wear.
- Upper eyelid margin at or above the superior limbus.
- History of ocular or lid surgery.
- Immediate family members or significant others of doctors or staff at the clinical site.
Key Trial Info
Start Date :
May 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04883099
Start Date
May 6 2021
End Date
October 31 2021
Last Update
January 19 2022
Active Locations (6)
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1
Complete Family Vision Care
San Diego, California, United States, 92123
2
Eola Eyes
Orlando, Florida, United States, 32803
3
Gaddie Eye Centers
Lexington, Kentucky, United States, 40517
4
Miamisburg Vision Care
Miamisburg, Ohio, United States, 45342