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The objective of this study is to demonstrate the ability of the Hydrus Implant to lower intraocular pressure in glaucoma patients undergoing cataract surgery.
This is a post-market, prospective, single-masked, randomized, controlled, multicenter clinical trial comparing Cataract Extraction (CE) surgery + Hydrus Implant vs CE surgery alone for the reduction of intraocular pressure (IOP) in patients with a positive diagnosis for open angle glaucoma (POAG) or pseudoexfoliative glaucoma. Eligible patients will be scheduled for cataract surgery. At the time of the procedure, qualified subjects will be randomized into 1 of 2 treatment groups: Hydrus Implant with cataract surgery or cataract surgery alone. Post-operative follow up will be conducted at regular intervals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IOL placement with Hydrus Implant | Experimental | Cataract extraction with intraocular lens (IOL) placement and Hydrus Implant |
|
| IOL placement only. | Active Comparator | Cataract Extraction with IOL placement only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrus Implant | Device |
| ||
| IOL placement |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in proportion of subjects with 20% reduction in mean diurnal Intraocular Pressure (IOP) at 24 months following the wash-out of all glaucoma medications. | The 24 month diurnal IOP will be compared to the baseline value and a % change will be determined for each subject. A 20% drop in diurnal IOP is a successful response to treatment. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in mean washed out IOP at 24 months | The mean diurnal IOP for each subject will be calculated and the sorted by group. The group average IOP will be compared to in-group baseline and between groups at the follow up time point. | 24 months |
| Change in Best-corrected Visual Acuity (BCVA) from baseline to 12 months as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Norbert Pfeiffer, MD | Universitatsmedizin Mainz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| See Central Contact | Frankfurt | Germany | ||||
| See Central Contact |
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|
A 24 month visit will be conducted to confirm 12 month findings. |
| 12 months |
| The proportion of eyes with IOP >5 mmHg to ≤19 mmHg following terminal washout. | A 24 month visit will be conducted to confirm 12 month findings. | 12 months |
| Diurnal IOP at 12 months following washout | A 24 month visit will be conducted to confirm 12 month findings | 12 months |
| Mainz |
| Germany |
| See Central Contact | Parma | Italy |
| See Central Contact | Torino | Italy |
| See Central Contact | Rotterdam | Netherlands |
| See Central Contact | Madrid | Spain |
| See Central Contact | Zaragoza | Spain |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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