- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07589894
Binocular and Monocular Distance-Corrected Visual Performance and Defocus Characteristics of Clareon Truplus Intraocular Lens (IOL) (BMVDI)
BMVDI Study: Binocular and Monocular Distance-Corrected Visual Performance and Defocus Characteristics of Clareon Truplus IOL
This study aims to generate data that characterizes visual outcomes, including the binocular distance-corrected intermediate visual acuity (DCIVA) at 66cm or defocus behavior, of the Clareon TruPlus modified monofocal intraocular lens (IOL).
Clareon TruPlus IOL is designed to provide an extended range of vision compared to the parent monofocal IOL. Clareon TruPlus IOL delivers excellent intermediate vision without compromising distance vision including the quality of vision with low incidence of visual disturbances in normal cataract patients.
Binocular distance-corrected intermediate visual acuity at 66cm will be assessed at a pre-specified postoperative interval 12 weeks after second eye surgery. This study hypothesizes that Clareon TruPlus IOL delivers good binocular DCIVA at 66cm 12 weeks after second eye surgery.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
California
-
Encino, California, Estados Unidos, 91316
- Colvard-Kandavel Eye Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Able and willing to understand and sign informed consent.
- Able and willing to complete all required study visits.
- Diagnosed with age-related cataracts in both eyes (OU)
- Bilateral age-related cataract scheduled for phacoemulsification in both eyes by a single surgeon.
- Surgeon predicts postoperative best corrected distance visual acuity (BCDVA) of ≥ 20/25 or better with Manifest Refractive Spherical Equivalent (MRSE) ±0.50 D of plano and in each eye post-operatively.
- Clear intraocular media aside from cataract.
- Will receive TruPlus bilaterally
- Postoperative residual astigmatism ≤ 0.75 D in both eyes.
- Refractive target: Emmetropia OU
- Patient groups agreeing to either Femtosecond Laser Assisted Cataract Surgery (FLACS) or Standard phaco
Exclusion Criteria:
- Ocular comorbidities affecting visual outcomes, including but not limited to:
- Macular disease (e.g., Age-Related Macular Degeneration [AMD], Diabetic Macular Edema [DME], Epiretinal Membrane [ERM]).
- Active ocular inflammation.
- Any investigator-determined condition likely to confound postoperative visual performance.
- Strabismus with or without amblyopia in either eye.
- Prior anterior or posterior segment surgery, including corneal refractive procedures.
- History of retinal detachment.
- Degenerative retinal or visual disorders deemed clinically significant by the investigator.
- Diagnosed glaucoma (of any stage, if deemed vision-impacting by investigator).
- Systemic conditions that could affect healing or study outcomes (e.g., immunocompromised, connective tissue disease, clinically significant atopy, diabetes).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Binocular distance-corrected intermediate visual acuity (DCIVA) and Logarithm of the Minimum Angle of Resolution (logMAR) at 66cm at 12 weeks after second eye surgery
Periodo de tiempo: Baseline and 12 weeks after second eye surgery
|
Baseline and 12 weeks after second eye surgery
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Monocular DCIVA at 66cm
Periodo de tiempo: Baseline and 12 weeks after second eye surgery
|
Baseline and 12 weeks after second eye surgery
|
|
Monocular and Binocular distance corrected Defocus curve (at 3m) from +1.00D to -2.50D
Periodo de tiempo: Baseline and 12 weeks after second eye surgery
|
Baseline and 12 weeks after second eye surgery
|
|
Monocular and Binocular Best Distance Corrected Visual Acuity (BDCVA)
Periodo de tiempo: Baseline and 12 weeks after second eye surgery
|
Baseline and 12 weeks after second eye surgery
|
|
Binocular Uncorrected Distance Visual Acuity (UDVA) at 4m, Uncorrected Intermediate Visual Acuity (UCIVA) at 66cm
Periodo de tiempo: Baseline and 12 weeks after second eye surgery
|
Baseline and 12 weeks after second eye surgery
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ganesha R Kandavel, MD, Coilvard-Kandavel Eye Center
Publicaciones y enlaces útiles
Publicaciones Generales
- Srinivasan S et al. Meta-analysis of Defocus Curves of Monofocal, Enhanced Monofocal, and EDoF IOLs. Giglio R, Tognetto D. Evaluation of an Enhanced Monofocal IOL Compared to Clareon Monofocal and Tecnis 1-Piece.
- Tran E, Shah N, Caballero Ortiz S, Kyveris A, Berg G, Chan T. Visual Performance and Refractive Stability of Clareon(R) Monofocal Intraocular Lens Implanted with an Automated Delivery System. Clin Ophthalmol. 2025 Oct 24;19:3933-3939. doi: 10.2147/OPTH.S545977. eCollection 2025.
- Blehm C. Visual Acuity Using a Defocus Curve and Refractive Stability in the Alcon Clareon IOL.
- Micheletti JM, Duncan NB, Hall B. Head-to-Head Comparison of Intermediate Vision of Two Monofocal Intraocular Lenses. Clin Ophthalmol. 2023 Dec 21;17:3983-3990. doi: 10.2147/OPTH.S444696. eCollection 2023.
- Beltraminelli T, Rizzato A, Toniolo K, Galli A, Menghini M. Comparison of visual performances of enhanced monofocal versus standard monofocal IOLs in a mini-monovision approach. BMC Ophthalmol. 2023 Apr 21;23(1):170. doi: 10.1186/s12886-023-02920-6.
- Park MJ, Lee HS, Chang IB, Hong IH. Improved Intermediate Visual Function with New Monofocal Intraocular Lens in Combined Cataract and Vitrectomy Surgery for Retinal Disease. Korean J Ophthalmol. 2023 Oct;37(5):401-408. doi: 10.3341/kjo.2023.0056. Epub 2023 Aug 25.
- Garzón, N., et al. Visual and optical quality of enhanced intermediate monofocal intraocular lenses. International Journal of Ophthalmology. 2022; 15(9): (description of the Tecnis® Eyhance ICB00 as having modified aspheric optics and improved intermediate vision with preserved distance visual acuity).
- Auffarth, G. U., et al. Clinical evaluation of a new monofocal intraocular lens with enhanced intermediate function in cataract patients. Journal of Cataract & Refractive Surgery. 2021; 47(2): (results showing improved intermediate vision with Tecnis Eyhance and comparable distance outcomes).
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
- BMVDI-102745323
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .