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Completed
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
Conditions: Cataract, Presbyopia, Hyperopia, Myopia, Pseudophakia
Sex: All
Ages: 18 Years – N/A
Enrollment: 21
Sponsor: Medicontur Medical Engineering Ltd
Location: Spain
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 BaselineSurgery: IOL implantationM1: 1 month +/- 2 weeks postoperative follow-upM3: 3 months +/- 1 month postoperative follow-upM12: 12 months +/- 3 months postoperative follow-up
Eligibility Criteria
Inclusion Criteria:Adult males or females above 18 years of age;Pseudophakic patients implanted with 640PM IOLs (Medicontur Medical Engineering Ltd. Inc., Zsámbék, Hungary);Diagnosis of cataract and/or ametropia and/or presbyopia;Subject who provided express consent authorizing the use of medical record data for biomedical research purposes.
Patients who have participated in at least two follow up visits in the 12 months following IOL implantationPatients for which the retrospective data for the primary endpoint is available and at least half of all the secondary endpoints measured in the time ranges specified in the protocol.Exclusion Criteria:Patients with any eye condition that could affect vision (corneal ectasia, retinal diseases, glaucoma, uveitis, dry eye or amblyopia, etc.);regular anterior corneal astigmatism ≥ 1.20 D or irregular astigmatism ≥ 0.5 μm measured with Pentacam at 4 mm.
Source: ClinicalTrials.gov (NCT05735990). StuddyBuddy aggregates publicly available trial information.