877PTY Toric IOL for Corneal Astigmatism
Data Collection
Collected from today forward - ProspectiveAstigmatism+2
+ Cataract
+ Eye Diseases
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: April 16, 2024
Actual date on which the first participant was enrolled.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)
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
Győr, HungaryOpen Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház in Google Maps