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

NCT ID: NCT06578884

Last Updated: 2024-08-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-16
• Study Completion Date: 2025-06-30

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)

Conditions

Cataract; Corneal Astigmatism

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

877PTY

100 patients/eyes implanted with 877PTY IOL

877PTY

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility 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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medicontur Medical Engineering Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház

Győr, , Hungary

Countries

Hungary

Other Identifiers

M-877PTY-HU-2301

Identifier Type: -

Identifier Source: org_study_id