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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date January 2019
Source Ivantis, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to demonstrate the ability of the Hydrus Implant to lower intraocular pressure in glaucoma patients undergoing cataract surgery.


Description:

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Hydrus Implant

Procedure:
IOL placement


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Ivantis, Inc.

Countries where clinical trial is conducted

Germany,  Italy,  Netherlands,  Spain, 

Outcome

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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