Trials / Withdrawn
WithdrawnNCT04054427
Implantation of a Trifocal Hydrophobic IOL in Patients That Underwent Refractive Surgery
Clinical Study to Investigate Visual Performance and Patient Satisfaction After Implantation of a Trifocal Hydrophobic IOL in Patients That Underwent Refractive Surgery
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Beaver-Visitec International, Inc. · Industry
- Sex
- All
- Age
- 45 Years
- Healthy volunteers
- Accepted
Summary
Controlled, open label, prospective Post Market Clinical Follow-Up, single-center clinical study to investigate visual performance after implantation of a trifocal IOL (PhysIOL Pod L GF) in patients that underwent refractive surgery.
Detailed description
This clinical investigation is a controlled, open label, prospective Post Market Clinical Follow-Up, single-center clinical study whereby patients undergoing routine cataract surgery that previously underwent refractive surgery prior to being screened will have bilateral implantation of trifocal intraocular lens FineVision POD L GF (PhysIOL, Liège, Belgium). The study purpose is to collect clinical data on visual acuity, contrast sensitivity and patient reported outcomes obtained on patients with cataracts and/or suffering from presbyopia that underwent refractive surgery prior to the IOL implantation. The device under investigation (FineVision POD L 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 28 patients will be recruited for this clinical study and receive a bilateral implantation of FineVision POD L GF intraocular lens. Subjects participating in the trial will attend a total of 9 study visits (1 preoperative, 2 operative and 6 postoperative) over a period of 6 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IOL implantation experimental | Implantation of trifocal IOL POD L GF consisting of hydrophobic material |
Timeline
- Start date
- 2021-11-01
- Primary completion
- 2022-05-01
- Completion
- 2022-05-01
- First posted
- 2019-08-13
- Last updated
- 2021-10-07
Source: ClinicalTrials.gov record NCT04054427. Inclusion in this directory is not an endorsement.