PMCF Study on EDOF (Isopure) vs Monofocal (Micropure) IOL
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cataract
- Lens Opacities
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Masking Description: Single-blind masking; Patient will not be informed which IOL model was implanted until end of the study.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 45 years and 125 years
- Gender
- Both males and females
Description
This is a multicenter, prospective, randomised, controlled, single-blind post-market clinical follow-up (PMCF) study whereby patients undergoing routine cataract surgery will have bilateral implantation of Enhanced Depth of Focus intraocular lenses (Isopure 1.2.3.) or monofocal lenses (Micropure 1.2...
This is a multicenter, prospective, randomised, controlled, single-blind post-market clinical follow-up (PMCF) study whereby patients undergoing routine cataract surgery will have bilateral implantation of Enhanced Depth of Focus intraocular lenses (Isopure 1.2.3.) or monofocal lenses (Micropure 1.2.3.). The patients will be randomized in a 1:1 ratio to receive the study or control lenses. Both IOLs, investigational device and control device, are CE approved and commercially available in the countries this clinical investigation 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 Europe and Asia. The device under investigation (Isopure 1.2.3.) is a hydrophobic, glistening-free, acrylic EDOF intraocular lens (IOL) manufactured by the sponsor of this study, PhysIOL sa/nv. The control lens is the parent IOL, belonging to the same IOL family of this manufacturer. It is a hydrophobic, glistening-free, acrylic monofocal IOL (Micropure 1.2.3.). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development. Subjects participating in the trial will attend a total of maximum 11 study visits (1 preoperative, 1 or 2 operative and up to 8 postoperative) over a period of 12 months. If local requirements allow, preoperative and operative visit can be done on the same day. Subjects would have the option for unscheduled visits if required medically. Primary endpoint data will be collected at the 120-180 days follow up visit. Secondary endpoint data will be collected at the 330-420 days follow up visit. Data interim analyses will be done after the last patient finished the 120-180 days postoperative examination to support the study publication plan.
Tracking Information
- NCT #
- NCT04249492
- Collaborators
- targomedGmbH
- Investigators
- Principal Investigator: Florian Kretz, MD Augentagesklinik Rheine