Astigmatism, Hyperopia, Myopia, Presbyopia
Conditions
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.
Interventions
DEVICEAPIOC for Presbyopia and APIOC for Presbyopia for Astigmatism
Contact Lenses for Presbyopia
Sponsors
Lentechs, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Vision Quality | Day 7 | Visual analogue scale (0-100 points) 100 is best possible quality of vision |
| Visual Acuity Near | Day 7 | High and Low Contrast |
| Visual Acuity Intermediate | Day 7 | High and Low Contrast |
| Visual Acuity Distance | Day 7 | High and Low Contrast LogMAR |
| Comfort | Day 7 | Visual analogue scale(0-100 points) 100 is best possible comfort |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed