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| Name | Class |
|---|---|
| Horizon 2020 - European Commission | OTHER |
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The trial objectives are to establish the safety & efficacy of using a DLTP laser to perform laser trabeculoplasty to reduce Intraocular Pressure (IOP) in patients with open angle glaucoma (Including Pigmentary & Exfoliative Glaucoma), that did not achieve adequate IOP control by conventional therapy.
This is a single site outpatient feasibility study assessing the safety & efficacy of the DLTP laser in the ability to reduce IOP in patients with open angle glaucoma (OAG). The investigational site will accrue patients with uncontrolled OAG. These eyes will be treated with the direct application of Direct Laser Trabeculoplasty (DLTP)/ Direct Selective Laser Trabeculoplasty automated device (DSLT).
Only one eye per patient is to be treated with the investigational device during the study.
The laser parameters used will be like these used in the Selective trabeculoplasty (SLT) device (CE/FDA approved), but all laser beams will be applied in about one-second, through the peri-limbal.
Subjects will be evaluated preoperatively and postoperatively at 1 hour, 2 hours (and hourly to 4 hours in the event of an IOP elevation in the immediate postop course), 1 day, 1 week, and 1, 3, 6 months.
Patients will be followed out to 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct Selective Trabeculoplasty | Experimental | Treatment by an Direct Selective Trabeculoplasty device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct Selective Trabeculoplasty device | Device | Patients will be treated with a Direct Selective Trabeculoplasty (DLTP) laser. Placement of the spots is on the sclera around the limbus. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Intra-Ocular pressure | Percentage reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment | 1,3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Intra-Ocular pressure | Percentage reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of medications | Number of medications after treatment, as compared to before treatment. | 6 months |
| Physician perception of the usability of the system. | Physician perception of the usability of the system. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alon Skaat, MD | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sam Rothberg Glaucoma Center Goldschleger Eye Institute Sheba meical Center | Ramat Gan | 52621 | Israel |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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No masking for treatment. The follow-up and primary endpoint assessment, intra-ocular pressure (IOP) measurement, is performed by masked ophthalmologist.
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| 1 month |