Trials / Completed
CompletedNCT04519814
Safety and Effectiveness of VISULAS Green Selective Laser Trabeculoplasty (SLT)
A Prospective, Multicenter Clinical Investigation to Evaluate Safety and Effectiveness of VISULAS Green Selective Laser Trabeculoplasty (SLT)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- Carl Zeiss Meditec AG · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
An interventional, open, prospective, multi-center pre-market clinical investigation according to §§20-23a Medizinproduktegesetz (MPG, medical devices act), in which a total of 40 eyes of 40 consecutive patients at up to five (5) clinical sites will be enrolled, treated with the VISULAS green with option CSLT, and followed for a three months period. The primary objective of this clinical investigation is to evaluate safety and effectiveness of SLT with the VISULAS green laser with option CSLT.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | selective laser trabeculoplasty (SLT) | Treatment will be performed on Day 0 using the VISULAS green with Option CSLT for SLT treatment and a mirror goniolens to visualize the trabecular meshwork. The initial energy level is set according to the grade of angle pigmentation and bubble formation. Approximately one hundred non-overlapping lesions will be applied in a single session to 360° of the trabecular meshwork. |
Timeline
- Start date
- 2020-06-30
- Primary completion
- 2021-11-23
- Completion
- 2022-09-13
- First posted
- 2020-08-20
- Last updated
- 2024-12-19
Locations
5 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT04519814. Inclusion in this directory is not an endorsement.