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

A Prospective, Multicenter, Open-label, Single-arm Clinical Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) IOL for Correction of Aphakia Following Cataract Extraction

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aphakia, Postcataract
• Intervention / Treatment: Device: KI-362-US1 (YP2.2VM)

• Study Type: Interventional
• Enrollment (Estimated): 340
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Director, Clinical Operations; Phone Number: 919-433-1600; Email: Clinical@KowaUS.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KI-362-US1; Participants in this study receive an artificial lens (intraocular lens) implanted in the eye to replace the eye's natural lens that has been removed due to cataract surgery. The lens is delivered using a single-use, preloaded device that helps the surgeon place the lens safely and precisely into the natural lens capsule of the eye.	Device: KI-362-US1 (YP2.2VM); Injector and one-piece (1P) monofocal IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants whose BCDVA Achieved 0.30 logMAR or Better at Form 5	A binary outcome of achieving best-corrected distance visual acuity (BCDVA) of 0.30 logarithm of the minimum angle of resolution (logMAR) or better, or not, at postoperative days 330-390 (Form 5) BCDVA will be measured using Early Treatment Diabetic Retinopathy Study (ETDRS) illuminated charts	Baseline (Form 0) through Visit 5 (Form 5), approximately Days 330-390
Proportion of Participants with Incidence of Selected Ocular Adverse Events	This safety outcome measure evaluates whether participants experience any of the following ocular adverse events after treatment, recorded as a binary outcome (occurrence: yes/no). Cumulative adverse events assessed include Cystoid macular edema, Hypopyon, Endophthalmitis, lens dislocation from the posterior chamber, Pupillary block, Retinal detachment, and secondary surgical interventions (excluding posterior capsulotomies). In addition, persistent adverse events are assessed as present or absent, including corneal stroma edema, persistent Cystoid macular edema, Iritis, and elevated intraocular pressure requiring treatment.	Baseline through end of study (up to 15 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants with Lens Axis Misalignment of <10 degrees From Baseline to Form 4	Evaluation of the rotational stability of the implanted monofocal IOL by assessing changes in lens axis alignment over time. Stability is determined using binary outcomes (yes/no) based on whether the absolute difference in lens position between baseline (Form 0) and follow-up visit (Form 4) remains within predefined thresholds.	Baseline (Form 0) through Visit 4 (Form 4), approximately Days 120-180
Proportion of Participants with Lens Axis Misalignment of <10 degrees From Baseline to Form 5	Evaluation of the rotational stability of the implanted monofocal IOL by assessing changes in lens axis alignment over time. Stability is determined using binary outcomes (yes/no) based on whether the absolute difference in lens position between baseline (Form 0) and follow-up visit (Form 5) remains within predefined thresholds.	Baseline (Form 0) through Visit 5 (Form 5), approximately Days 330-390
Proportion of Participants with Lens Axis Misalignment of <20 degrees From Baseline to Form 4	Evaluation of the rotational stability of the implanted monofocal IOL by assessing changes in lens axis alignment over time. Stability is determined using binary outcomes (yes/no) based on whether the absolute difference in lens position between baseline (Form 0) and follow-up visit 4 (Form 4) remains within predefined thresholds.	Baseline (Form 0) through Visit 4 (Form 4), approximately Days 120-180
Proportion of Participants with Lens Axis Misalignment of <20 degrees From Baseline to Form 5	Evaluation of the rotational stability of the implanted monofocal IOL by assessing changes in lens axis alignment over time. Stability is determined using binary outcomes (yes/no) based on whether the absolute difference in lens position between baseline (Form 0) and follow-up visit (Form 5) remains within predefined thresholds.	Baseline (Form 0) through Visit 5 (Form 5), approximately Days 330-390

Collaborators and Investigators

• Sponsor: Kowa Research Institute, Inc.
• Investigators: Study Chair: Shona Pendse, MD, MMSc, Kowa Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Aphakia; Aphakia, Postcataract
• Other Study ID Numbers: KI-362-US1-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes