APIOC for Presbyopia and APIOC for Presbyopia With Astigmatism (NCT04883099) | Clinical Trial Compass
CompletedNot Applicable
APIOC for Presbyopia and APIOC for Presbyopia With Astigmatism
United States50 participantsStarted 2021-05-06
Plain-language summary
Vision and comfort, both objective and subjective, will be assessed for single vision contact lens wearers for either the APIOCâ„¢ for Presbyopia or the APIOCâ„¢ for Presbyopia Astigmatism contact lenses.
Who can participate
Age range40 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.