A Prospective Clinical Investigation to Evaluate the Safety and Performance of 877PTY Toric IOL for Visual Correction of Corneal Astigmatism

• Conditions: Cataract; Corneal Astigmatism
• Interventions: Device: 877PTY

• Registration Number: NCT06578884
• Lead Sponsor: Medicontur Medical Engineering Ltd

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-16
• Study First Submitted: 2024-06-10
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-28
• Last Update Submitted: 2024-08-28
• Study First Posted: 2024-08-30
• Last Update Posted: 2024-08-30
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
877PTY	877PTY	100 patients/eyes implanted with 877PTY IOL

Primary Outcome Measures

Name	Time	Method
Primary Performance Endpoint - CDVA	6 months postoperatively	Visual acuity: monocular CDVA at 6 months after IOL implantation

Secondary Outcome Measures

Name	Time	Method
Secondary Performance Endpoint - UDVA	6 months postoperatively	Visual acuity: monocular UDVA at 6 months after IOL implantation
Secondary Performance Endpoint - Subjective CYL	6 months postoperatively	Subjective (manifest) cylinder and keratometric cylinder of the eye at 6 months postoperatively
Secondary Performance Endpoint - Residual CYL and SEQ	6 months postoperatively	Residual manifest cylinder and spherical equivalent at 6 months postoperatively;
Secondary Performance Endpoint - Rotational stability	6 months postoperatively	IOL rotational stability at 6 months after IOL implantation;
Secondary Performance Endpoint - Injector handling	6 months postoperatively	Ease of IOL implantation and positioning at surgery;
Secondary Performance Endpoint - Patient satisfaction (VFQ-25)	6 months postoperatively	Patient-reported visual functions: overall global vision rating, difficulty with near and distance vision activities, social functioning and role limitations, dependency on others, mental health symptoms due to vision, driving difficulties, limitations with peripheral and color vision, and ocular pain evaluated by visual function questionnaire at 6 months after IOL implantation.
Secondary Performance Endpoint - Glistening	6 months postoperatively	Glistening rate and severity at 6 months after IOL implantation

Trial Locations

Locations (1)

Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház; 🇭🇺 Győr, Hungary