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

Not Applicable

Completed

• Conditions: Cataract; Primary Open Angle Glaucoma (POAG)
• Interventions: Procedure: Cataract Surgery; Device: CyPass Micro-Stent

• Registration Number: NCT01085357
• Lead Sponsor: Transcend Medical, Inc.

Brief 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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-03-01
• Study First Submitted QC: 2010-03-10
• Study First Posted: 2010-03-11
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Disposition First Submitted: 2016-02-24
• Disposition First Submitted QC: 2016-02-24
• Disposition First Posted: 2016-03-24
• Results First Submitted: 2016-08-25
• Results First Submitted QC: 2016-08-25
• Results First Posted: 2016-10-20
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-12
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 897

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CyPass Micro-Stent + Cataract Surgery	CyPass Micro-Stent	Subjects receive the CyPass Micro-Stent at the conclusion of their cataract surgery
Cataract Surgery Only	Cataract Surgery	Subjects do not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
CyPass Micro-Stent + Cataract Surgery	Cataract Surgery	Subjects receive the CyPass Micro-Stent at the conclusion of their cataract surgery

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
Mean Change in IOP Between Baseline and Hypotensive Medication-free 24-month Postoperative Examination Using Baseline Value Imputation for Missing Data	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.
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	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.