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Not yet recruiting 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

No phase Interventional Aphakia, Postcataract

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KI-362-US1 (YP2.2VM).
Who it may be relevant to
Registry conditions: Aphakia, Postcataract. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Device KI-362-US1 (YP2.2VM)
    Injector and one-piece (1P) monofocal IOL

Primary outcome measures

  • 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]
  • Proportion of Participants with Incidence of Selected Ocular Adverse Events [Time frame: Baseline through end of study (up to 15 months)]
Secondary outcome measures (4)
  • 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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07650201 · KI-362-US1-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗