Recruiting

Intraocular Lens

Sponsor:

Kowa Research Institute, Inc.

Code:

NCT07650201

Conditions

Aphakia, Postcataract

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

KI-362-US1 (YP2.2VM)

Study Details

Brief summary:

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.

Conditions

Aphakia, Postcataract

Study ID

NCT07650201

Start date

Oct 30, 2026

Status verified date

Nov, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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 Design

Enrollment

340 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: KI-362-US1

Participants receive an intraocular lens (IOL) implanted during cataract surgery to replace the natural lens of the eye. The IOL is delivered using a single-use, preloaded delivery device and positioned within the eye's natural lens capsule.

Interventions

KI-362-US1 (YP2.2VM)

Injector and one-piece (1P) monofocal IOL

Primary outcome measure

  • Proportion of Participants Achieving a Predefined BCDVA Criterion at Visit 5 [ Time Frame: Baseline through Visit 5, approximately Days 330-390. ]
  • Proportion of Participants With Selected Ocular Adverse Events [ Time Frame: Baseline through end of study (up to 15 months) ]

Central Contacts and Locations

Central contacts

Director, Clinical Operations

919-433-1600Clinical@KowaUS.com

Locations

Beverly Hills Institute of Ophthalmology

Recruiting

Beverly Hills, California, United States, 90210

Icon EyeCare

Recruiting

Grand Junction, Colorado, United States, 81501

North Georgia Eye Associates

Recruiting

Gainesville, Georgia, United States, 30501

Ophthalmology Consultants Ltd

Recruiting

St Louis, Missouri, United States, 63128

Carolina Eyecare Physicians

Recruiting

Mt. Pleasant, South Carolina, United States, 29464

Houston Eye Associates, North Loop

Recruiting

Houston, Texas, United States, 77008

Berkeley Eye

Recruiting

Houston, Texas, United States, 77027

Texas Eye Research

Recruiting

Hurst, Texas, United States, 76054

Piedmont Eye Center

Recruiting

Lynchburg, Virginia, United States, 24502

More Information

Sponsor

Kowa Research Institute, Inc.

Last update posted

Nov 13, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-14. This information was provided to ClinicalTrials.gov by Kowa Research Institute, Inc. on 2026-11-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.