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 APIOC™ for Presbyopia or the APIOC™ for Presbyopia Astigmatism contact lenses.
Who can participate
Age range
40 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.