NCT03065036

Brief Summary

The purpose of this study is to evaluate the ocular hypotensive effect of the Hydrus Aqueous Implant (Standard and Low-Profile), as determined by the change in IOP from baseline (preoperative) and change in the number of glaucoma medications from baseline.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2010

Longer than P75 for phase_1

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

3.7 years

First QC Date

February 29, 2012

Last Update Submit

January 31, 2019

Conditions

Primary Open Angle Glaucoma

Keywords

Primary Open Angle GlaucomaPOAG

Outcome Measures

Primary Outcomes (1)

  • Change in IOP of study eye between each randomized group

    Effectiveness will be determined by comparing the IOP at the baseline (pre-operative) visit to the the IOP at the 12 month post-operative visit.

    Baseline & One year

Secondary Outcomes (1)

  • Change in glaucoma medications

    Baseline & One year

Study Arms (2)

Hydrus Aqueous Implant

EXPERIMENTAL

Hydrus implanted into Schlemm's Canal.

Drug: prestudy topical glaucoma medications

IOL placement and Hydrus implant

OTHER

Cataract Extraction with IOL placement and Hydrus implant into Schlemm's canal

Drug: prestudy topical glaucoma medications

Interventions

prestudy topical glaucoma medicationsDRUG

Reintroduction of prestudy topical glaucoma medications, introduced one medication at a time during each study visit, as necessary.

Hydrus Aqueous ImplantIOL placement and Hydrus implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elevated intraocular pressure (IOP)
  • Diagnosis of mild to advanced open-angle glaucoma
  • Shaffer Grade III
  • Mental capacity to cooperate when undergoing operative and postoperative examination
  • years of age or older
  • Provide written informed consent
  • Willing and able to return to scheduled follow-up examinations for 24-months

You may not qualify if:

  • Closed-angle and narrow-angle forms of glaucoma
  • Secondary glaucomas
  • Congenital or developmental glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University Medical Center Vienna

Vienna, A-1090, Austria

Location

Aurelios Augenzentrum

Recklinghausen, Erlbruch, Germany

Location

Unknown Facility

Berlin, 10559, Germany

Location

Universitatsmedizin der Johannes Gutenberg-Universitat Mainz Augenklinik und Poliklinik

Mainz, 55131, Germany

Location

Unknown Facility

Tijuana, Estado de Baja California, Mexico

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Prof. Dr. Manfred Tetz, MD

    Augentagesklinik Spreebogen Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2012

First Posted

February 27, 2017

Study Start

March 1, 2010

Primary Completion

November 1, 2013

Study Completion

February 1, 2014

Last Updated

February 4, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)ME(1)AU(1)