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

N/ACompletedNCT02023242

Ivantis, Inc.152 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

152

Conditions

Primary Open Angle Glaucoma Pseudoexfoliative Glaucoma Pigmentary Glaucoma

Interventions

Hydrus MicrostentDEVICE

Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.

iStent Trabecular Micro BypassDEVICE

Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 84 Years

Medical Language ↔ Plain English

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

Locations (1)

Contact Richard Hope at Ivantis

Irvine, California, United States

Outcomes

Primary Outcomes

Unmedicated IOP </= 19 mmHg at 12 Months

Percentage of subjects with IOP \</= 19 mmHg and without the use of ocular hypotensive medications at 12 months

Time frame: 12 months

Secondary Outcomes

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

Time frame: 12 & 24 Months

Mean Medication Use at 12 and 24 Months

The mean medication use at 12 and 24 months

Time frame: 12 & 24 Months

Unmedicated IOP </= 19 mmHg at 24 Months

Percentage of subjects with IOP \</= 19 mmHg and without the use of ocular hypotensive medications at 24 months

Time frame: 24 Months

Unmedicated IOP </= 18 mmHg at 12 Months

Percentage of subjects with IOP \</= 18 mmHg and without the use of ocular hypotensive medications at 12 months

Time frame: 12 months

Data from ClinicalTrials.gov

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