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Study of an Implantable Device for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery | Clinical Trials | Clareo Health

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

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

NCT01085357•Transcend Medical, Inc.

View on ClinicalTrials.gov

Summary

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.

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.

Eligibility

Age

45 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

September 1, 2009

Primary Completion Date

March 1, 2015

Completion Date

March 1, 2015

Last Updated

May 15, 2017

Enrollment

897

ACTUAL participants

Conditions

Primary Open Angle Glaucoma (POAG)Cataract

Interventions

Cataract Surgery

PROCEDURE

CyPass Micro-Stent

DEVICE

Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation

NCT06979752

Glaucoma, Open Angle, Pseudo-exfoliativeCataract

View study

RECRUITING

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

NCT07362043

Cataract Surgery

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 15, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

IC-8 Apthera IOL New Enrollment Post Approval Study

HUD Surgical Guidance for Toric Alignment

PRO-232 in Patients Subjected to Cataract Surgery

Outcomes of Clareon PanOptix Pro in Patients With Prior Myopic Refractive Surgery