Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| all eligible patients | Experimental | A total of 40 eyes in 40 consecutive patients, 22 years of age or older, with primary open-angle glaucoma (HPG + NPG), who did not reach target pressure, agree to participate in the study, and will be able to complete clinical follow-up and evaluation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| selective laser trabeculoplasty (SLT) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | one (1) month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | one (1) month |
| mean absolute change in intraocular pressure (IOP) compared to baseline at month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| rate of patients achieving >0 to <10% IOP reduction from baseline | The following exploratory endpoint will be determined additionally: - rate of patients achieving >0 to <10% IOP reduction from baseline at 1 and 3 months | three (3) month |
| rate of patients achieving 10% to <20% IOP reduction from baseline |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik und Poliklinik für Augenheilkunde, TU Dresden | Dresden | Germany | ||||
| Internationale Innovative Ophthalmochirurgie GbR |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36572747 | Result | Pillunat KR, Kretz FTA, Koinzer S, Ehlken C, Pillunat LE, Klabe K. Effectiveness and safety of VISULAS(R) green selective laser trabeculoplasty: a prospective, interventional multicenter clinical investigation. Int Ophthalmol. 2023 Jul;43(7):2215-2224. doi: 10.1007/s10792-022-02617-7. Epub 2022 Dec 26. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
The endpoint is the mean change in IOP (Absolute value, mmHg) of the study cohort compared to baseline at month 3 |
| 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 | three (3) months |
The following exploratory endpoint will be determined additionally: - rate of patients achieving 10% to <20% IOP reduction from baseline at 1 and 3 months |
| three (3) month |
| rate of patients achieving ≥20% IOP reduction from baseline | The following exploratory endpoints will be determined additionally: - rate of patients achieving ≥20% IOP reduction from baseline at 1 and 3 months. | three (3) month |
| Post-operative intraocular pressure (IOP) in mmHg | Outcome Parameters Safety: Post-operative intraocular pressure (IOP) in mmHg: 1h, 1d | one (1) day |
| Rate of intraoperative Adverse Device Effects | Outcome Parameters Safety: Rate of intraoperative Adverse Device Effects | one (1) day |
| Rate of Adverse Device Effects and Device Deficiencies | Outcome Parameters Safety: Rate of Adverse Device Effects and Device Deficiencies over the entire course of the investigation | three (3) month |
| Rate of Adverse Events and Severe Adverse Events | Outcome Parameters Safety: Rate of Adverse Events and Severe Adverse Events over the entire course of the clinical investigation | three (3) month |
| Düsseldorf |
| Germany |
| Augenarztpraxis am Dreiecksplatz, Kiel | Kiel | Germany |
| Klinik für Augenheilkunde, UK Schleswig Holstein | Kiel | Germany |
| Augentagesklinik Rheine | Rheine | Germany |