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The study is designed to assess the safety of Hyaluronan Thiomer i.o. implant in patients with primary open angle glaucoma undergoing a combined phacoemulsification - non penetrating deep sclerectomy procedure.
In this study, Hyaluronan Thiomer i.o. will be implanted during a combined surgery of cataract and non - penetrating deep sclerectomy in a group of 16 patients with primary open angle glaucoma and clinically significant cataract. Given that a considerable number of glaucoma patients also suffer from cataract, it is reasonable to test Hyaluronan Thiomer i.o. during a combined procedure of phacoemulsification and deep sclerectomy. This is also of importance because a combined procedure avoids the need of a second operation in this group of patients. Finally, it has been shown that combined phacoemulsification - deep sclerectomy does not induce a further risk compared to deep sclerectomy alone(open phase I study).
Safety will be assessed based on the occurrence of adverse events.
Efficacy assessments will be performed at every visit and efficacy analysis will include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronan Thiomer i.o. implantable device | Other | active treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronan Thiomer i.o. implant | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Safety will be based on the occurrence of adverse events. | Safety will be assessed up to 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Efficacy will be assessed based on postoperative IOP reduction, assessment of the proportion of subjects needing additional IOP lowering medication and the proportion of subjects needing postoperative Neodymium:YAG goniopuncture. | Efficacy assessments will be performed up to 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
Any of the following will exclude a subject from the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Medical University of Vienna, Austria | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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