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

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)

Study Overview

• Status: Enrolling by invitation
• Conditions: Cataract; Corneal Astigmatism
• Intervention / Treatment: Device: 877PTY

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Hungary
  • Győr, Hungary, 9024
    • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Aphakic adult patients (18 years old and older), with cataract and corneal astigmatism who aspire to have improved uncorrected distance vision and reduction of the residual refractive cylinder and assigned to monocular or binocular implantation with 877PTY IOL.

Description

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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
877PTY; 100 patients/eyes implanted with 877PTY IOL	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Performance Endpoint - CDVA	Visual acuity: monocular CDVA at 6 months after IOL implantation	6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Performance Endpoint - UDVA	Visual acuity: monocular UDVA at 6 months after IOL implantation	6 months postoperatively
Secondary Performance Endpoint - Subjective CYL	Subjective (manifest) cylinder and keratometric cylinder of the eye at 6 months postoperatively	6 months postoperatively
Secondary Performance Endpoint - Residual CYL and SEQ	Residual manifest cylinder and spherical equivalent at 6 months postoperatively;	6 months postoperatively
Secondary Performance Endpoint - Rotational stability	IOL rotational stability at 6 months after IOL implantation;	6 months postoperatively
Secondary Performance Endpoint - Injector handling	Ease of IOL implantation and positioning at surgery;	6 months postoperatively
Secondary Performance Endpoint - Patient satisfaction (VFQ-25)	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.	6 months postoperatively
Secondary Performance Endpoint - Glistening	Glistening rate and severity at 6 months after IOL implantation	6 months postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoints - Intraoperative complications	Intraoperative complications of cataract surgery; Posterior capsular or zonular rupture; Vitreous loss/anterior vitrectomy or aspiration; Iris/ciliary body injury; Loss of nuclear material into vitreous; Suprachoroidal haemorrhage; Retrobulbar haemorrhage	Up to day 1 postoperatively
Safety Endpoints - Postoperative complications	Postoperative complications of cataract surgery; Cystoid macular oedema; Iris abnormalities; Corneal oedema; Wound leak or rupture; IOL dislocation, removal, or exchange; Inflammation (Endophthalmitis, anterior chamber cells, anterior chamber flare, hypopyon); Retinal tear, break, or detachment; Persistent iritis; Elevated intraocular pressure; Pupillary block; Cornea status	Up to month 1 postoperatively
Safety Endpoints - Complications of IOL implantation	Complications of IOL implantation; Posterior capsular opacification (PCO); Opacification, IOL discoloration	Up to month 6 postoperatively

Collaborators and Investigators

• Sponsor: Medicontur Medical Engineering Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: cataract; aphakic; intraocular lens (IOL); astigmatism correction
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Astigmatism
• Other Study ID Numbers: M-877PTY-HU-2301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No