NCT06578884

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Medicontur Medical Engineering Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-04-16
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2024-08-30
• Last updated: 2024-08-30

Locations

1 site across 1 country: Hungary