Study of an Implantable Device for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery (COMPASS)

Transcend Medical

Status: Completed

Conditions: Cataract; Primary Open Angle Glaucoma (POAG)

Treatments: Device: CyPass Micro-Stent; Procedure: Cataract Surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT01085357

TMI-09-01

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of the CyPass Implant for lowering intraocular pressure (IOP) in patients with glaucoma who undergo cataract surgery.

Full description

This study is a modified and expanded protocol based on acceptable safety results from an earlier feasibility study. The trial is conducted using a 3:1 randomization (treatment to control) in which patients are screened for eligibility, randomized at time of surgery and followed for 24 months postoperatively.

Enrollment: 897 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Preoperative Inclusion Criteria:

• Diagnosis of primary open angle glaucoma (POAG)
• Mean diurnal unmedicated IOP of 21 - 33 mmHg
• Normal anterior chamber angle anatomy at site of implantation
• Operable age-related cataract

Exclusion Criteria:

• Use of more than 3 ocular hypotensive medications (combination medications count as 2 medications)
• Significant risk associated with washout of ocular hypotensive medication
• Previous glaucoma surgery (with exception of laser treatments to the trabecular meshwork)
• Previous corneal surgery
• Clinically significant ocular pathology, other than cataract and glaucoma
• Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic, pseudoexfoliative, pigmentary or neovascular glaucoma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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897 participants in 2 patient groups

CyPass Micro-Stent + Cataract Surgery

Experimental group

Description:

Subjects receive the CyPass Micro-Stent at the conclusion of their cataract surgery

Treatment:

Device: CyPass Micro-Stent

Procedure: Cataract Surgery

Cataract Surgery Only

Active Comparator group

Description:

Subjects do not receive the CyPass Micro-Stent at the conclusion of their cataract surgery

Treatment:

Procedure: Cataract Surgery