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

May 12, 2017 updated by: Transcend Medical, Inc.

A Prospective, Randomized, Comparative, MultiCenter Clinical Study to Assess the Safety and Effectiveness of the Transcend CyPass Glaucoma Implant in Patients With Open Angle Glaucoma Undergoing Cataract Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

897

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CyPass Micro-Stent + Cataract Surgery
Subjects receive the CyPass Micro-Stent at the conclusion of their cataract surgery
Procedure: Cataract Surgery
Cataract Surgery involves the removal of the natural lens, which has become clouded (called a cataract), and insertion of an artificial lens (called an intraocular lens). This procedure is done through a small surgical incision in the eye.
Device: CyPass Micro-Stent
The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye. The CyPass is implanted in the eye after completion of cataract surgery.
Active Comparator: Cataract Surgery Only
Subjects do not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
Procedure: Cataract Surgery
Cataract Surgery involves the removal of the natural lens, which has become clouded (called a cataract), and insertion of an artificial lens (called an intraocular lens). This procedure is done through a small surgical incision in the eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Eyes With ≥ 20% Decrease in Intraocular Pressure (IOP) From Baseline to the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data
Time Frame: Baseline; Month 24 postoperative
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Non-responders include subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.
Baseline; Month 24 postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in IOP Between Baseline and Hypotensive Medication-free 24-month Postoperative Examination Using Baseline Value Imputation for Missing Data
Time Frame: Baseline; Month 24 postoperative
IOP was assessed using Goldmann applanation tonometry and reported in mmHg. A negative value indicates an improvement. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Baseline IOP was used for subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.
Baseline; Month 24 postoperative
Proportion of Eyes With Postoperative IOP ≥ 6 and ≤ 18 mmHg, as Measured by Goldmann Tonometry, at the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data
Time Frame: Month 24 postoperative
IOP was assessed using Goldmann applanation tonometry and reported in mmHg. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Non-responders include subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.
Month 24 postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Transcend Medical, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 1, 2010

First Submitted That Met QC Criteria

March 10, 2010

First Posted (Estimate)

March 11, 2010

Study Record Updates

Last Update Posted (Actual)

May 15, 2017

Last Update Submitted That Met QC Criteria

May 12, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMI-09-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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