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

Ivantis

Status: Completed

Conditions: Primary Open Angle Glaucoma; Pigmentary Glaucoma; Pseudoexfoliative Glaucoma

Treatments: Device: iStent Trabecular Micro Bypass; Device: Hydrus Microstent

Study type: Interventional

Funder types: Industry

Identifiers

NCT02023242

CP-12-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 152 patients

Sex: All

Ages: 45 to 84 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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152 participants in 2 patient groups

Hydrus Microstent

Experimental group

Description:

Patients randomized to the Hydrus Microstent .

Treatment:

Device: Hydrus Microstent

iStent Trabecular Micro Bypass

Active Comparator group

Description:

Patients randomized to the iStent Trabecular Micro Bypass

Treatment:

Device: iStent Trabecular Micro Bypass