NCT04874376

PMCF Retrospective Study Outcomes of a Premium Monofocal IOL

Clinical Study to Investigate Visual Performance, Contrast Sensitivity and Patient Satisfaction After Implantation of a Premium Monofocal Intraocular Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Beaver-Visitec International, Inc. · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Accepted

Summary

Multicentric, retro- / prospective, open-label, observational PMCF study to investigate visual performance, contrast sensitivity and patient satisfaction after mono- or bilateral implantation of Isopure 1.2.3. intraocular lenses following cataract surgery. The study treatment itself is not part of this observational clinical investigation. Only patients that already have been implanted with the device under investigation qualify for this retro- prospective observational clinical study.

Detailed description

The study is a multicentric, retro- / prospective, open-label, observational PMCF study to investigate visual performance, contrast sensitivity and patient satisfaction after mono- or bilateral implantation of Isopure 1.2.3. intraocular lenses following cataract surgery. The study treatment itself is not part of this observational clinical investigation. Only patients that already have been implanted with the device under investigation qualify for this retro- prospective observational clinical study. Isopure 1.2.3. is CE approved and commercially available in the countries this clinical investgation is being carried out. The investigational device and all study products, including the devices used for the study examinations, will be used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the patient. The study will be carried out in up to five clinical centers in Spain. The device under investigation (Isopure 1.2.3.) is a hydrophobic, glistening-free, acrylic Premium Monofocal intraocular lens (IOL) manufactured by the sponsor of this study, PhysIOL sa/nv. Subjects participating in the trial will attend a total of maximum 1 study visit (from 120 days post-operative). This study visit will be minimum 20 days after the surgery of the 2nd eye. Subjects would have the option for unscheduled visits if required medically. The primary performance endpoint is to show that the monocular Best Corrected Distance Visual Acuity (CDVA) measured in the study group is statistically non-inferior to outcomes of the monofocal parent lens Micropure 1.2.3. The comparative data is used from the latest Clinical Evaluation Report (CER) for the monofocal Micropure 1.2.3. lens. To avoid bias, only the first implanted eye will be considered for this calculation. Data interim analyses will be done after the last patient finished the 1 study visit postoperative examination to support the study publication plan.

Conditions

• Cataract
• Lens Opacities

Interventions

Type	Name	Description
DEVICE	IOL implantation experimental (Isopure 1.2.3.)	Implantation of Premium Monofocal Isopure 12.3 with retrospective data collection

Timeline

• Start date: 2021-05-24
• Primary completion: 2022-01-12
• Completion: 2022-01-12
• First posted: 2021-05-05
• Last updated: 2022-07-20

Locations

6 sites across 1 country: Spain