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NCT Number: NCT07650201

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 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.

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Key information

Conditions

Aphakia, Postcataract Aphakia Eye Diseases Lens Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KI-362-US1 (YP2.2VM)

Device

Injector and one-piece (1P) monofocal IOL

Primary outcomes

  1. Proportion of Participants whose BCDVA Achieved 0.30 logMAR or Better at Form 5

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

    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

  2. Proportion of Participants with Incidence of Selected Ocular Adverse Events

    Time frame: Baseline through end of study (up to 15 months)

    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.

Secondary outcomes

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

    Time frame: Baseline (Form 0) through Visit 4 (Form 4), approximately Days 120-180

    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.

  2. Proportion of Participants with Lens Axis Misalignment of <10 degrees From Baseline to Form 5

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

    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.

  3. Proportion of Participants with Lens Axis Misalignment of <20 degrees From Baseline to Form 4

    Time frame: Baseline (Form 0) through Visit 4 (Form 4), approximately Days 120-180

    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.

  4. Proportion of Participants with Lens Axis Misalignment of <20 degrees From Baseline to Form 5

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Director, Clinical Operations

CONTACT

[email protected]

919-433-1600

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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