APIOC for Presbyopia and APIOC for Presbyopia With Astigmatism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-06

Study Completion Date

2021-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Presbyopia Myopia Hyperopia Astigmatism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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APIOC for Presbyopia and Presbyopia with Astigmatism

Presbyopic Spherical or Toric Contact Lens

Group Type EXPERIMENTAL

APIOC for Presbyopia and APIOC for Presbyopia for Astigmatism

Intervention Type DEVICE

Contact Lenses for Presbyopia

Interventions

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APIOC for Presbyopia and APIOC for Presbyopia for Astigmatism

Contact Lenses for Presbyopia

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. The subject must provide written informed consent.
2. The subject must appear willing and able to adhere to the instructions set forth in this protocol.
3. At least 40 years of age and no more than 70 years of age.
4. ≤ 4.00 D of corneal astigmatism.
5. ≤ 2.50 D of refractive astigmatism.
6. Refractive error range +4.00 DS to -6.00 DS
7. Require a reading addition (bifocal) of at least 0.75 D
8. Flat and steep keratometry readings within 40 to 48 D.
9. Clear, healthy corneas with no irregular astigmatism.
10. Normal, healthy conjunctiva in both eyes.
11. Free of active ocular disease. Refractive error and presbyopia are permitted.
12. Be a current or former (within the last 3 years) contact lens wearer.
13. Best-corrected near and distance visual acuity better than or equal to 20/25.

Exclusion Criteria

1. Irregular corneal astigmatism.
2. Corneal scarring unless off line-of-site and well healed.
3. Pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear.
4. 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.
5. Systemic disease that would interfere with contact lens wear.
6. Currently pregnant or lactating (by self-report).
7. 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.
8. Active allergies that may inhibit contact lens wear.
9. Upper eyelid margin at or above the superior limbus.
10. History of ocular or lid surgery.
11. Immediate family members or significant others of doctors or staff at the clinical site.

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes