Trials / Completed
CompletedNCT03306342
Visual Performance, Patient Satisfaction and PCO Rate After Implantation of a Trifocal Hydrophobic IOL
Clinical Study to Investigate Visual Performance, Patient Satisfaction and PCO Rate After Implantation of a Trifocal Hydrophobic IOL
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Beaver-Visitec International, Inc. · Industry
- Sex
- All
- Age
- 45 Years
- Healthy volunteers
- Accepted
Summary
Prospective, controlled, single-surgeon, single-center post-market clinical follow up study to investigate the clinical outcomes of a hydrophobic trifocal IOL (PhysIOL POD F GF)
Detailed 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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IOL implantation experimental | Implantation of trifocal IOL POD F GF consisting of hydrophobic material |
Timeline
- Start date
- 2018-02-02
- Primary completion
- 2020-11-10
- Completion
- 2020-11-11
- First posted
- 2017-10-11
- Last updated
- 2022-01-11
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03306342. Inclusion in this directory is not an endorsement.