NCT01818115

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
4 countries

7 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

January 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2012

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

March 26, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

4.6 years

First QC Date

February 29, 2012

Last Update Submit

January 31, 2019

Conditions

Primary Open Angle GlaucomaGlaucoma, Open Angle, Pseudo-exfoliativeCataract Unilateral Pending Extraction

Keywords

POAGPXGIOL SurgeryCE Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Reduction in mean washed out IOP at 24 months

    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.

    12 months

  • The proportion of eyes with IOP >5 mmHg to ≤19 mmHg following terminal washout.

    12 months

  • Diurnal IOP at 12 months following washout

    12 months

Study Arms (2)

IOL placement with Hydrus Implant

EXPERIMENTAL

Cataract extraction with intraocular lens (IOL) placement and Hydrus Implant

Device: Hydrus Implant

IOL placement only.

ACTIVE COMPARATOR

Cataract Extraction with IOL placement only.

Procedure: IOL placement

Interventions

Hydrus ImplantDEVICE
IOL placement with Hydrus Implant
IOL placementPROCEDURE
IOL placement only.

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Primary Open Angle Glaucoma or Pseudoexfoliative Glaucoma.
  • Operable, age-related cataract eligible for phacoemulsification.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

See Central Contact

Frankfurt, Germany

Location

See Central Contact

Mainz, Germany

Location

See Central Contact

Parma, Italy

Location

See Central Contact

Torino, Italy

Location

See Central Contact

Rotterdam, Netherlands

Location

See Central Contact

Madrid, Spain

Location

See Central Contact

Zaragoza, Spain

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Prof. Norbert Pfeiffer, MD

    Universitatsmedizin Mainz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2012

First Posted

March 26, 2013

Study Start

January 1, 2011

Primary Completion

August 1, 2015

Study Completion

November 1, 2015

Last Updated

February 4, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)DE(2)ES(2)IT(2)