NCT05735990

Retrospective Clinical Investigation of the Safety and Performance of 640PM Trifocal IOL Implantation in Patients With Cataract and/or Ametropia (Hyperopia, Myopia) and/or Presbyopia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 21 (actual)
• Sponsor: Medicontur Medical Engineering Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The clinical investigation objective is to evaluate safety and performance outcomes of trifocal IOL implantation to improve vision in patients with cataract and/or ametropia (hyperopia, myopia) and/or presbyopia. Retrospective data from preoperative status up to 12 month postoperative status will be collected from patients that were implanted with Medicontur's 640PM intraocular lens: * Preoperative status: Preoperative Screening and Baseline * Surgery: IOL implantation * M1: 1 month +/- 2 weeks postoperative follow-up * M3: 3 months +/- 1 month postoperative follow-up * M12: 12 months +/- 3 months postoperative follow-up

Conditions

• Cataract
• Presbyopia
• Hyperopia
• Myopia
• Pseudophakia

Interventions

Type	Name	Description
DEVICE	Intraocular lens	Aspheric hydrophilic acrylic IOL for implantation into the capsular bag

Timeline

• Start date: 2022-10-27
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2023-02-21
• Last updated: 2023-02-21

Locations

1 site across 1 country: Spain