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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

10. juni 2026 opdateret af: Kowa Research Institute, Inc.

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

340

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: KI-362-US1
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.
Enhed: KI-362-US1 (YP2.2VM)
Injector and one-piece (1P) monofocal IOL

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Participants whose BCDVA Achieved 0.30 logMAR or Better at Form 5
Tidsramme: 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
Baseline (Form 0) through Visit 5 (Form 5), approximately Days 330-390
Proportion of Participants with Incidence of Selected Ocular Adverse Events
Tidsramme: 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.
Baseline through end of study (up to 15 months)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Participants with Lens Axis Misalignment of <10 degrees From Baseline to Form 4
Tidsramme: 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.
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
Tidsramme: 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.
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
Tidsramme: 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.
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
Tidsramme: 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.
Baseline (Form 0) through Visit 5 (Form 5), approximately Days 330-390

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kowa Research Institute, Inc.

Efterforskere

  • Studiestol: Shona Pendse, MD, MMSc, Kowa Research Institute, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. november 2028

Studieafslutning (Anslået)

1. november 2028

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KI-362-US1-301

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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Kliniske forsøg med Afaki, postkatarakt

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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CROs in Azerbaijan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner