Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (I… (NCT07650201) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
340 participantsStarted 2026-08
Plain-language summary
A study to learn how well an artificial lens, called an intraocular lens (IOL), works in adults who have cataract surgery. During this type of surgery, the eye's natural lens is removed and replaced with an artificial lens to help restore vision.
The main goal of the study is to evaluate vision after the lens is placed in the eye. About one year after surgery, participants' vision will be measured to understand how clearly they can see.
The study will also look at how the lens performs over time, including how well it remains in place in the eye.
The results of this study will help provide more information about how this lens performs in adults undergoing cataract surgery.
Who can participate
Age range
22 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:
* Are able and willing to provide written informed consent, attend all scheduled visits, and comply with all trial procedures and follow-up
* Have a study eye with visually significant cataract for which phacoemulsification cataract extraction and posterior chamber IOL implantation is indicated
* Meet all other inclusion criteria outlined in the clinical study protocol
Exclusion Criteria:
* Have serious systemic disease that could increase operative risk or conditions that can confound the surgical outcome
* Within 30 days of the Screening Visit, use of systemic medications with significant ocular side effects or any medications that could confound the outcome or increase participant risk
* Meet any other exclusion criteria outlined in the clinical study protocol
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.
What they're measuring
1
Proportion of Participants whose BCDVA Achieved 0.30 logMAR or Better at Form 5
Timeframe: Baseline (Form 0) through Visit 5 (Form 5), approximately Days 330-390
2
Proportion of Participants with Incidence of Selected Ocular Adverse Events
Timeframe: Baseline through end of study (up to 15 months)