Trials / Active Not Recruiting
Active Not RecruitingNCT04632784
Clinical Trial With Artiflex Presbyopic (Artiplus)
Prospective Multicentre Clinical Trial With the Artiflex Presbyopic (Artiplus), an Iris-fixated Multifocal Intraocular Lens for the Correction of Presbyopia in Phakic Eyes
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 49 (estimated)
- Sponsor
- Ophtec BV · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this clinical trial is to evaluate the effectiveness and safety of the multifocal Artiflex Presbyopic (Artiplus) intraocular lens.
Detailed description
The study is a prospective, open-label, single-arm, and multicentre clinical investigation with three years of follow-up. Artiflex Presbyopic (Artiplus) is a phakic intraocular lens to be implanted in the anterior chamber, intended for adult subjects and indicated for the optical correction of presbyopia and spherical error requiring a correction.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Artiflex Presbyopic (Artiplus) implantation | Implantation of iris-fixated multifocal Artiflex Presbyopic IOL (Artiplus) |
Timeline
- Start date
- 2021-11-12
- Primary completion
- 2023-11-26
- Completion
- 2026-11-26
- First posted
- 2020-11-17
- Last updated
- 2025-02-20
Locations
7 sites across 2 countries: South Korea, Spain
Source: ClinicalTrials.gov record NCT04632784. Inclusion in this directory is not an endorsement.