APIOC for Presbyopia and APIOC for Presbyopia With Astigmatism

Not Applicable

Completed

• Conditions: Astigmatism; Myopia; Hyperopia; Presbyopia
• Interventions: Device: APIOC for Presbyopia and APIOC for Presbyopia for Astigmatism

• Registration Number: NCT04883099
• Lead Sponsor: Lentechs, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-04
• Study Start: 2021-05-06
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-12
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-17
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
APIOC for Presbyopia and Presbyopia with Astigmatism	APIOC for Presbyopia and APIOC for Presbyopia for Astigmatism	Presbyopic Spherical or Toric Contact Lens

Primary Outcome Measures

Name	Time	Method
Visual Acuity Intermediate	Day 7	High and Low Contrast
Visual Acuity Distance	Day 7	High and Low Contrast LogMAR
Subjective Vision Quality	Day 7	Visual analogue scale (0-100 points) 100 is best possible quality of vision
Comfort	Day 7	Visual analogue scale(0-100 points) 100 is best possible comfort
Visual Acuity Near	Day 7	High and Low Contrast

Secondary Outcome Measures

Name	Time	Method
Subjective vision Comparison	Day 7	Compared to habitual lenses, rated as better/same/worse
Subjective Comfort	Day 7	Compared to habitual lenses, rated as better/same/worse

Trial Locations

Locations (6)

Eola Eyes; 🇺🇸 Orlando, Florida, United States

Gaddie Eye Centers; 🇺🇸 Lexington, Kentucky, United States

Miamisburg Vision Care; 🇺🇸 Miamisburg, Ohio, United States

Complete Family Vision Care; 🇺🇸 San Diego, California, United States

Eyecare Professionals of Powell; 🇺🇸 Powell, Ohio, United States

Vision Professionals; 🇺🇸 New Albany, Ohio, United States