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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 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2026-06-16

No results posted yet for this study

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

Interventions

DEVICE

KI-362-US1 (YP2.2VM)

Injector and one-piece (1P) monofocal IOL

Sponsors & Collaborators

  • Kowa Research Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Shona Pendse, MD, MMSc · Kowa Research Institute, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-11-30
Completion
2028-11-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07650201 on ClinicalTrials.gov