Status:

COMPLETED

Hydrus Microstent for Refractory Open-Angle Glaucoma

Lead Sponsor:

Ivantis, Inc.

Conditions:

Open-angle Glaucoma

Eligibility:

All Genders

45+ years

Phase:

NA

Brief Summary

The purpose of this study is to assess the safety and effectiveness of the Hydrus Microstent in patients with refractory open-angle glaucoma.

Detailed Description

Participants will attend a screening visit, a baseline visit, a surgery visit, and 8 post-operative visits (Day 1, Day 7, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12), for a total individual...

Eligibility Criteria

Inclusion

  • Open-angle glaucoma with optic nerve pathology;
  • Best Corrected Visual Acuity of 20/80 or better in study eye;
  • Refractory glaucoma;
  • Other protocol-specified inclusion criteria may apply.

Exclusion

  • Secondary glaucoma other than pseudoexfoliative and pigmentary glaucoma;
  • Acute angle closure, chronic angle closure, or congenial, malignant, or developmental glaucoma;
  • Pre-perimetric glaucoma;
  • Ocular hypertension
  • Shallow or flat anterior chamber;
  • Other protocol-specified exclusion criteria may apply.

Key Trial Info

Start Date :

August 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 16 2022

Estimated Enrollment :

217 Patients enrolled

Trial Details

Trial ID

NCT03267134

Start Date

August 1 2017

End Date

December 16 2022

Last Update

December 14 2023

Active Locations (20)

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Page 1 of 5 (20 locations)

1

Vold Vision

Fayetteville, Arkansas, United States, 72704

2

Sacramento Eye Consultants

Sacramento, California, United States, 95815

3

Eye Center of Northern Colorado

Fort Collins, Colorado, United States, 80528

4

Ocala Eye

Ocala, Florida, United States, 34474

Hydrus Microstent for Refractory Open-Angle Glaucoma | DecenTrialz