Lente intraocular tórica 877PTY para astigmatismo corneal
Colección de datos
Recopilados desde hoy en adelante - ProspectivoAstigmatismo+2
+ Catarata
+ Enfermedades Oculares
Casos y Controles
Examen de las características de personas con una enfermedad para identificar factores genéticos o ambientales que contribuyen a la condición.Resumen
Fecha de inicio: 16 de abril de 2024
Fecha en la que se inscribió al primer participante.Medicontur preloaded hydrophobic monofocal toric intraocular lenses (IOLs) are indicated to improve vision at far distance in adults with or without cataract and correction of pre-existing corneal astigmatism secondarily to removal of the crystalline lens. The intraocular lens is intended to be surgically implanted into the eye with the purpose of restoring optical function in the aphakic eye to provide an optical system with high predictability of the precalculated dioptric power. The investigation will be performed as a prospective, non-comparative, single arm study with a single center design. Patients will be enrolled who are assigned to be implanted with the 877PTY IOLs mono- or binocularly between January 2024 - June 2025. Data from six visits will be collected: * Visit 1: Screening and Baseline (up to 90 days prior to the surgery) * Visit 2: IOL implantation (Day 0) * Visit 3: Day 1 post-operatively (+/- 0 day) * Visit 4: Day 7 post-operatively (+/- 3 days) * Visit 5: Month 1 post-operatively (+/- 2 weeks) * Visit 6: Month 6 post-operatively (+/- 1 month)
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 100 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Casos y Controles
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * adult patients (18 years old and older); * cataract and/or corneal astigmatism diagnosis; * indication for cataract surgery or refractive lens exchange; * recommended cylinder correction with toric IOL with cylinder power ≥1.0D; * clear intraocular media other than cataract; * signed informed consent form; Exclusion Criteria: * irregular astigmatism; * patients who are not targeted to emmetropia (predicted residual spherical equivalent and/or astigmatism is out of the range of ±0.5D and ±0.38D respectively); * any retinopathy or maculopathy that affects the vision; * iris neovascularization; * congenital eye abnormality affecting visual performance; * advanced glaucoma; * pseudoexfoliation syndrome affecting IOL stability; * amblyopia; * uveitis; * retinal detachment; * prior ocular surgery in personal medical history; * irregular corneal curvature or corneal diseases affecting visual performance; * high myopia (axial length ≥ 26,5 mm); * inadequate visualization of the fundus on preoperative examination; * dilated pupil size not large enough to visualize toric IOL axis markings postoperatively based on the Investigator's decision; * eye trauma in medical history; * instability of keratometry or biometry measurements; * prior corneal refractive surgery such as LASIK, PRK, or SMILE; * patients deemed ineligible by the investigator because of any systemic disease or treatment; * pregnancy or lactation; * current use of systemic steroids or external ophthalmic drugs; * concurrent participation in another drug or device investigation. Intraoperative exclusions: the presence of the following intraoperative exclusion criteria will lead to the exclusion of the subject: \- Any unexpected or serious intraoperative complication that makes IOL implantation impossible or results in implantation of another type of IOL that is outside the scope of this clinical trial.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
Győr, HungaryAbrir Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház en Google Maps