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The aim of the study is to evaluate the safety and effectiveness of the IOPtiMate (OT-135P) in Laser Assisted Non-Penetrating Glaucoma surgery in Open-Angle and Pseudoexfoliative Glaucoma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IOPtiMate | Experimental | patients will undergo non-penetrating laser assisted filtering surgery by the IOPtiMate (OT-134) system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser Assisted Non-penetrating glaucoma surgery | Device | A layer by Layer ablation of the deep sclera (under the superficial scleral flap) to achieve functional fluid percolation of the inner eye humor without penetration. |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-Ocular Pressure (IOP) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of anti-Glaucoma Medications | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noa Geffen, Dr. | Glaucoma service, Ophthalmology ward, Meir Hospital, Kfar-Saba | Principal Investigator |
| Shlomo Melamed, Dr. | Glaucoma service, Ophthalmology ward, Sheba Hospital, Tel-Hashomer Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmology ward, Meir Hospital | Kfar Saba | Israel |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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