Clinical Evaluation of Visco-Assisted CyPass® Micro-Stent Implantation in Patients With Open Angle Glaucoma (ViscoPass)

Randomized, Prospective Clinical Evaluation of the Safety and Effectiveness of Visco-Assisted CyPass® Implantation in Patients With Open Angle Glaucoma

The purpose of this study is to assess the safety and effectiveness of the use of visco-assisted CyPass® Micro-Stent implantation for the lowering of intraocular pressure (IOP) in subjects who have open angle glaucoma (OAG).

Study Overview

• Status: Completed
• Conditions: Open Angle Glaucoma
• Intervention / Treatment: Device: CyPass Micro-Stent; Device: Viscoelastic

Detailed Description

The study was conducted in 2 phases. Only one eye per subject was treated for each independent phase.

Dose Selection Phase (Cohort 1): Subjects were randomized in a 1:1:1 ratio and implanted with either a CyPass Micro-Stent with targeted delivery of 30 microliters (μl) ophthalmic 5 viscoelastic, a CyPass Micro-Stent with targeted delivery of 60 μl of ophthalmic viscoelastic, or a CyPass Micro-Stent without adjunct viscoelastic in the study eye.

Expansion Phase (Cohort 2): Subjects were randomized in a 1:1 ratio and implanted with either the CyPass Micro-Stent without adjunct viscoelastic or the CyPass Micro-Stent with 60 μl of ophthalmic viscoelastic (based on Dose Selection results). Subjects were randomized to treatment on the day of their surgical procedure. A total of 9 scheduled visits were planned including Screening (Day -45 to -2), Baseline (Day -15 to -1), Surgery (Day 0), 1 Day (Day 1), 1 Week (Day 5-9), 1 Month (Day 21-35), 3 Month (Day 70-98), 6 Month (Day 150-210), and 12 Month (Day 330-420) visits. The total expected duration of participation for each subject was up to 13 months.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Lubeck, Germany
    • Transcend Medical Investigative Site
  • Mainz, Germany
    • Transcend Medical Investigative Site
  • Neubrandenburg, Germany
    • Transcend Medical Investigative Site
• Panama
  • Panama City, Panama
    • Transcend Medical Investigative Site
• Poland
  • Warsaw, Poland
    • Transcend Medical Investigative Site
• Spain
  • Madrid, Spain
    • Transcend Medical Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of open angle glaucoma;
• Unmedicated IOP between 21 - 36 mmHg, inclusive;
• Normal angle anatomy at site of intended CyPass Micro-Stent implantation.

Exclusion Criteria:

• Advanced glaucoma;
• Prior incisional glaucoma surgery;
• Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma;
• Clinically significant ocular pathology other than glaucoma.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: CyPass; CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye	Device: CyPass Micro-Stent; Small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye in order to reduce intraocular pressure. Designed to be permanently implanted in the eye.; Other Names: Model 2FX
EXPERIMENTAL: CyPass30; CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic	Device: CyPass Micro-Stent; Small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye in order to reduce intraocular pressure. Designed to be permanently implanted in the eye.; Other Names: Model 2FX; Device: Viscoelastic; Healon 5 ophthalmic viscoelastic used to increase the size of the aqueous drainage area created by the CyPass Micro-Stent
EXPERIMENTAL: CyPass60; CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic	Device: CyPass Micro-Stent; Small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye in order to reduce intraocular pressure. Designed to be permanently implanted in the eye.; Other Names: Model 2FX; Device: Viscoelastic; Healon 5 ophthalmic viscoelastic used to increase the size of the aqueous drainage area created by the CyPass Micro-Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With ≥ 20% Decrease From Baseline to 12 Months Postoperative in IOP Without Use of Ocular Hypotensive Medication	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.	Baseline (Day -1), Month 12 PostOperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Device-related Ocular Adverse Events	A device related adverse event (AE) was any AE that was considered to be possibly, probably, or definitely related to the device in the opinion of the investigator. Reported categorically as intraoperative (start date on the date of surgery) and postoperative (start date after surgery). One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.	Up to Month 12 PostOperative
Mean Change From Baseline to 12 Months Postoperative in Medicated IOP	IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A higher negative change indicates improvement. One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.	Baseline (Day -1), Month 12 PostOperative
Percentage of Eyes Using Ocular Hypotensive Medication at 12 Months	The use of ocular hypotensive medications was assessed in subjects with at least one IOP-lowering medication at 12 Months. One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.	Month 12 PostOperative
Mean Change From Screening to 12 Months Postoperative in Number of Topical IOP-lowering Medications Used	The number of IOP lowering medications in subjects at 12 months was compared to medicated baseline. A higher negative change indicates improvement. One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.	Screening (Day -2), Month 12 PostOperative

Collaborators and Investigators

• Sponsor: Transcend Medical, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 21, 2013
• Primary Completion (ACTUAL): June 22, 2017
• Study Completion (ACTUAL): June 22, 2017

Study Registration Dates

• First Submitted: May 12, 2015
• First Submitted That Met QC Criteria: May 14, 2015
• First Posted (ESTIMATE): May 20, 2015

Study Record Updates

• Last Update Posted (ACTUAL): June 12, 2019
• Last Update Submitted That Met QC Criteria: May 29, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: TMI-13-01; GLD122-P001 (OTHER: Alcon)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes