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 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Director, Clinical Operations
- Número de teléfono: 919-433-1600
- Correo electrónico: Clinical@KowaUS.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
Injector and one-piece (1P) monofocal IOL
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of Participants whose BCDVA Achieved 0.30 logMAR or Better at Form 5
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of Participants with Lens Axis Misalignment of <10 degrees From Baseline to Form 4
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Shona Pendse, MD, MMSc, Kowa Research Institute, Inc.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KI-362-US1-301
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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