Primary Open Angle Glaucoma Clinical Trial
— Hydrus IIOfficial title:
A Prospective, Multi-Center, Randomized Controlled Trial to Evaluate the Safety and Effectiveness of the Hydrus Implant for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery.
NCT number | NCT01818115 |
Other study ID # | CP-10-001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2011 |
Est. completion date | November 2015 |
Verified date | January 2019 |
Source | Ivantis, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to demonstrate the ability of the Hydrus Implant to lower intraocular pressure in glaucoma patients undergoing cataract surgery.
Status | Completed |
Enrollment | 100 |
Est. completion date | November 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of Primary Open Angle Glaucoma or Pseudoexfoliative Glaucoma. - Operable, age-related cataract eligible for phacoemulsification. Exclusion Criteria: - Closed Angle and narrow angle forms of Glaucoma. - Other Secondary Glaucoma, (such as neovascular, uveitic, traumatic, steroid induced, lens induced); glaucoma associated with increase episcleral venous pressure; congenital or developmental glaucoma. |
Country | Name | City | State |
---|---|---|---|
Germany | See Central Contact | Frankfurt | |
Germany | See Central Contact | Mainz | |
Italy | See Central Contact | Parma | |
Italy | See Central Contact | Torino | |
Netherlands | See Central Contact | Rotterdam | |
Spain | See Central Contact | Madrid | |
Spain | See Central Contact | Zaragoza |
Lead Sponsor | Collaborator |
---|---|
Ivantis, Inc. |
Germany, Italy, Netherlands, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Change in Best-corrected Visual Acuity (BCVA) from baseline to 12 months as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart. | A 24 month visit will be conducted to confirm 12 month findings. | 12 months | |
Secondary | 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 | |
Secondary | Diurnal IOP at 12 months following washout | A 24 month visit will be conducted to confirm 12 month findings | 12 months |
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