Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cataract
  • Lens Opacities
  • Presbyopia
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 45 years and 125 years
Gender
Both males and females

Description

This clinical investigation is a prospective, controlled, single-surgeon, single-center post-market clinical follow up study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses FineVision POD F GF (PhysIOL, Liège, Belgium). The study p...

This clinical investigation is a prospective, controlled, single-surgeon, single-center post-market clinical follow up study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses FineVision POD F GF (PhysIOL, Liège, Belgium). The study purpose is to obtain clinical data on visual acuity, contrast sensitivity, questionnaire outcomes and PCO rate on patients implanted with FineVision POD F GF. The device under investigation (FineVision POD F GF) is a trifocal glistening-free hydrophobic acrylic intraocular lens (IOL) manufactured by the sponsor of this study PhysIOL sa/nv. The IOL will be implanted as part of the routine cataract surgery on patients suffering from cataract development. In total 25 patients will be recruited for this clinical study and receive a bilateral implantation of FineVision POD F GF intraocular lens. Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 24 months.

Tracking Information

NCT #
NCT03306342
Collaborators
Not Provided
Investigators
Principal Investigator: Béatrice Cochener, Prof. Département d'ophtalmologie - CHU Morvan Bâtiment 4 bis
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