A Prospective Clinical Investigation to Evaluate the Safety and Performance of 877PTY Toric IOL for Visual Correction of Corneal Astigmatism
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: 877PTY.
- Кому может быть актуально
- Состояния в реестре: Cataract, Corneal Astigmatism. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Венгрия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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)
Вмешательства
- Устройство 877PTY
IOL implantation with 6-month follow-up period Monocular UDVA/CDVA Manifest Refraction (SPH, CYL, SEQ) Optical Biometry, Keratometry (K1, K2, AXL, ACD) IOL axis orientation determination Visual function questionnaire Glistening evaluation Tonometry Slit-Lamp examination Fundus visualization
Первичные конечные точки
- Primary Performance Endpoint - CDVA [Срок оценки: 6 months postoperatively]
Вторичные конечные точки (7)
- Secondary Performance Endpoint - UDVA [Срок оценки: 6 months postoperatively]
- Secondary Performance Endpoint - Subjective CYL [Срок оценки: 6 months postoperatively]
- Secondary Performance Endpoint - Residual CYL and SEQ [Срок оценки: 6 months postoperatively]
- Secondary Performance Endpoint - Rotational stability [Срок оценки: 6 months postoperatively]
- Secondary Performance Endpoint - Injector handling [Срок оценки: 6 months postoperatively]
- Secondary Performance Endpoint - Patient satisfaction (VFQ-25) [Срок оценки: 6 months postoperatively]
- Secondary Performance Endpoint - Glistening [Срок оценки: 6 months postoperatively]
Критерии участия
Критерии включения
- 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;
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Венгрия · 1 центр
- Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház — Győr
Идентификаторы
NCT: NCT06578884 · M-877PTY-HU-2301