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

Medicontur

Status: Completed

Conditions: Myopia; Pseudophakia; Cataract; Presbyopia; Hyperopia

Treatments: Device: Intraocular lens

Study type: Observational

Funder types: Industry

Identifiers

NCT05735990

M_640PM_ES_2202

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 implantation
• Patients 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.

Trial design

21 participants in 1 patient group

640PM implanted

Description:

Patients implanted binocularly with Medicontur's intraocular lens model 640PM.

Treatment:

Device: Intraocular lens