Trials / Completed
CompletedNCT04933487
Rotational Stability Analysis of a Toric Monofocal IOL
Prospective Evaluation of the Rotational Stability of the Ankoris Intraocular Lens
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Beaver-Visitec International, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
This is a single-center, prospective PMCF study whereby patients undergoing routine cataract surgery will have monolateral implantation of hydrophilic monofocal toric intraocular lens Ankoris.
Detailed description
This is a single-center, prospective, nonrandomized PMCF study whereby patients undergoing routine cataract surgery will have monolateral implantation of hydrophilic monofocal toric intraocular lens (Ankoris). The device under investigation is manufactured by the sponsor of this study. The refractive power of the lens has a spherical and a cylindrical component. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development and showing pre-existing corneal astigmatism. The primary objective of this study is to determine the rotational stability of the Ankoris intraocular lens. The secondary objective is to measure the residual astigmatism after Ankoris implantation with respect to the targeted astigmatism correction. In total approx. 20 eyes of 20 patients will be recruited for this clinical study. Follow-ups will be performed 1 day, 1 month, and 3 months after cataract surgery. Subjects would have the option for unscheduled visits if required medically.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IOL implantation experimental | Monolateral implantation of toric intraocular lenses Ankoris. (Manufactured by PhysIOL sa/nv, Liège, Belgium). |
Timeline
- Start date
- 2014-08-26
- Primary completion
- 2016-01-01
- Completion
- 2019-03-01
- First posted
- 2021-06-21
- Last updated
- 2021-06-21
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04933487. Inclusion in this directory is not an endorsement.