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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
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.
Klinik und Poliklinik für Augenheilkunde, TU Dresden
Dresden, Germany
Internationale Innovative Ophthalmochirurgie GbR
Düsseldorf, Germany
Augenarztpraxis am Dreiecksplatz, Kiel
Kiel, Germany
Klinik für Augenheilkunde, UK Schleswig Holstein
Kiel, Germany
mean absolute change in intraocular pressure (IOP) compared to baseline at month 1
The endpoint is the mean change in IOP (Absolute value, mmHg) of the study cohort compared to baseline at month 1
Time frame: one (1) month
mean relative change in intraocular pressure (IOP) compared to baseline at month 1
The endpoint is the mean change in IOP (relative value, %) of the study cohort compared to baseline at month 1
Time frame: one (1) month
mean absolute change in intraocular pressure (IOP) compared to baseline at month 3
The endpoint is the mean change in IOP (Absolute value, mmHg) of the study cohort compared to baseline at month 3
Time frame: three (3) months
mean relative change in intraocular pressure (IOP) compared to baseline at month 3
The endpoint is the mean change in IOP (relative value, %) of the study cohort compared to baseline at month 3
Time frame: three (3) months
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Augentagesklinik Rheine
Rheine, Germany