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A Prospective Clinical Investigation to Evaluate the Safety and Performance of 877PTY Toric IOL for Visual Correction of Corneal Astigmatism
Sponsor: Medicontur Medical Engineering Ltd
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2024-04-16
Completion Date
2025-06-30
Last Updated
2024-08-30
Healthy Volunteers
No
Conditions
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
Locations (1)
Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
Győr, Hungary