Enrolling by invitation

877PTY Toric IOL for Corneal Astigmatism

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Astigmatism+2

+ Cataract

+ Eye Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: April 2024
See protocol details

Summary

Principal SponsorMedicontur Medical Engineering Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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)

Official TitleA Prospective Clinical Investigation to Evaluate the Safety and Performance of 877PTY Toric IOL for Visual Correction of Corneal Astigmatism
NCT06578884
Principal SponsorMedicontur Medical Engineering Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

AstigmatismCataractEye DiseasesLens DiseasesRefractive Errors

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

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

Suspended

Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház

Győr, HungaryOpen Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház in Google Maps
Enrolling by invitationOne Study Center