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

NCT06578884 | Enrolling By Invitation

• 1 other identifier: M-877PTY-HU-2301
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

cataract; intraocular lens (IOL); astigmatism correction; aphakic

Outcome Measures

Primary Outcomes (1)

• Primary Performance Endpoint - CDVA

  Visual acuity: monocular CDVA at 6 months after IOL implantation

  6 months postoperatively

Secondary Outcomes (7)

• Secondary Performance Endpoint - UDVA

  6 months postoperatively

• Secondary Performance Endpoint - Subjective CYL

  6 months postoperatively

• Secondary Performance Endpoint - Residual CYL and SEQ

  6 months postoperatively

• Secondary Performance Endpoint - Rotational stability

  6 months postoperatively

• Secondary Performance Endpoint - Injector handling

  6 months postoperatively

Other Outcomes (3)

• Safety Endpoints - Intraoperative complications

  Up to day 1 postoperatively

• Safety Endpoints - Postoperative complications

  Up to month 1 postoperatively

• Safety Endpoints - Complications of IOL implantation

  Up to month 6 postoperatively

Study Arms (1)

877PTY

100 patients/eyes implanted with 877PTY IOL

Device: 877PTY

Interventions

877PTY 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

877PTY

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Medicontur Medical Engineering Ltd: lead

Study Sites (1)

Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház

Győr, 9024, Hungary

Location

MeSH Terms

Conditions

Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: August 30, 2024
• Study Start: April 16, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 30, 2024

Record last verified: 2024-08

Locations

HU (1)