Comparing Effectiveness of the Hydrus Microstent (TM) to Two iStents to Lower IOP in Phakic Eyes

Primary Open Angle Glaucoma Clinical Trial

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Official title:

A Prospective, Multicenter, Randomized Comparison of the Hydrus to the iStent® for Lowering Intraocular Pressure in Primary Open Angle Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023242
• Other study ID #: CP-12-001
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: January 2018

Study information

• Verified date: November 2019
• Source: Ivantis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients.

Description:

This is a prospective, multicenter, single-masked, randomized clinical trial comparing the Hydrus Microstent to two iStent implants for the reduction of intraocular pressure in phakic patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma. Post-operative follow-up visits will be conducted at regular intervals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: January 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 84 Years

Eligibility

Inclusion Criteria:

• A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary glaucoma (PG)

• A phakic lens with BCVA of 20/30 or better

Exclusion Criteria:

• Forms of primary or secondary glaucoma not listed above

• Prior glaucoma surgery in the study eye

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Pigmentary Glaucoma
• Primary Open Angle Glaucoma
• Pseudoexfoliative Glaucoma

Intervention

Device:
• Hydrus Microstent
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
• iStent Trabecular Micro Bypass
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.

Locations

Country	Name	City	State
United States	Contact Richard Hope at Ivantis	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Ivantis, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unmedicated IOP </= 19 mmHg at 12 Months	Percentage of subjects with IOP	12 months
Secondary	The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months	The percentage of subjects who are not using ocular hypotensive medications at 12 and 24 months	12 & 24 Months
Secondary	Mean Medication Use at 12 and 24 Months	The mean medication use at 12 and 24 months	12 & 24 Months
Secondary	Unmedicated IOP </= 19 mmHg at 24 Months	Percentage of subjects with IOP	24 Months
Secondary	Unmedicated IOP </= 18 mmHg at 12 Months	Percentage of subjects with IOP	12 months