NCT07650201 · Kowa Research Institute, Inc.
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
What this study is about
This study is designed to evaluate how well an artificial lens, called an intraocular lens (IOL), performs in adults undergoing cataract surgery. During cataract surgery, the eye's natural lens is removed and replaced with an artificial lens to improve vision. The main goal of the study is to evaluate participants' vision after the IOL is placed in the eye.
View original scientific description
This study is designed to evaluate how well an artificial lens, called an intraocular lens (IOL), performs in adults undergoing cataract surgery. During cataract surgery, the eye's natural lens is removed and replaced with an artificial lens to improve vision. The main goal of the study is to evaluate participants' vision after the IOL is placed in the eye. Approximately one year after surgery, participants' vision will be assessed to determine how clearly they can see. The results of this study will provide additional information about the performance of the IOL in adults undergoing cataract surgery.
Interventions
DEVICE
KI-362-US1 (YP2.2VM)
Injector and one-piece (1P) monofocal IOL
Primary outcome measures
Proportion of Participants Achieving a Predefined BCDVA Criterion at Visit 5
Time frame: Baseline through Visit 5, approximately Days 330-390.
Proportion of participants achieving a predefined best-corrected distance visual acuity (BCDVA) criterion, as measured using Early Treatment Diabetic Retinopathy Study (ETDRS) illuminated charts at postoperative days 330-390 (Visit 5, Form 5).
Proportion of Participants With Selected Ocular Adverse Events
Time frame: Baseline through end of study (up to 15 months)
Proportion of participants experiencing one or more predefined ocular adverse events following treatment, including both cumulative and persistent events. Events are assessed based on their occurrence or persistence during the study period.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Beverly Hills, California
- Grand Junction, Colorado
- Gainesville, Georgia
- St Louis, Missouri
- Mt. Pleasant, South Carolina
- Houston, Texas
- Hurst, Texas
- Lynchburg, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 13, 2026 · Source of record for eligibility and locations