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

NCT07650201 | Not Yet Recruiting FDA Device

• 1 other identifier: KI-362-US1-301
• Study Type: interventional
• Target: 340
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Aphakia, Postcataract

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Proportion of Participants with Lens Axis Misalignment of <10 degrees From Baseline to Form 4

  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

  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

  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

  Baseline (Form 0) through Visit 5 (Form 5), approximately Days 330-390

Study Arms (1)

KI-362-US1

EXPERIMENTAL

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)

Interventions

KI-362-US1 (YP2.2VM) DEVICE

Injector and one-piece (1P) monofocal IOL

KI-362-US1

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kowa Research Institute, Inc.: lead

MeSH Terms

Conditions

Aphakia, Postcataract

Condition Hierarchy (Ancestors)

Aphakia; Lens Diseases; Eye Diseases

Study Officials

• Shona Pendse, MD, MMSc

  Kowa Research Institute, Inc.

  STUDY CHAIR

Central Study Contacts

Director, Clinical Operations

CONTACT

919-433-1600; Clinical@KowaUS.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share