Post Approval Study of the CyPass System

NCT03273907 | Terminated Results FDA Device

• 1 other identifier: GLD122c-C001
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 20

Brief Summary

The purpose of this study is to demonstrate that the rate of clinically relevant complications associated with CyPass Micro-Stent placement and stability using the CyPass 241-S applier, as determined at 36 months in the postmarket setting, is less than the pre-specified performance target, which is based on experience with the CyPass Model E applier in COMPASS trial TMI-09-01 (NCT01085357).

Conditions

Primary Open-angle Glaucoma; Cataract

Keywords

CyPass Micro-Stent

Outcome Measures

Primary Outcomes (1)

• Percentage of Eyes With Clinically Relevant Complications Associated With CyPass Micro-Stent Placement and Stability as Determined at Month 36

  Device-related complications, as specified in the protocol, included: * Failure to implant CyPass, defined as inability to successfully deploy or insert the CyPass. * Clinically significant CyPass malposition, defined as CyPass positioning after deployment such that: * The device is not in the supraciliary space, or * Clinical sequela resulting from device position including, but not limited to: * Secondary surgical intervention to modify device position (eg, repositioning, proximal end trimming or explantation) * Corneal endothelial touch by device * Corneal edema leading to loss of BCDVA \> 2 lines at the last postoperative visit, in comparison with preoperative BCDVA * Progressive ECL, defined as ongoing reduction in endothelial cell count of 30% or more relative to the screening ECD value, where 'ongoing reduction in endothelial cell count' is defined as losses continuing after Visit 5 (6 Month Follow-up).

  Up to Month 36 postoperative

Secondary Outcomes (6)

• Mean Change in IOP From Baseline at Month 36

  Baseline, Month 36 postoperative

• Percentage of Eyes With IOP Reduction 20 Percent or More From Baseline While Using the Same or Fewer Topical Ocular Hypotensive Medications at Month 36

  Baseline, Month 36 postoperative

• Percentage of Eyes Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg at Month 36

  Month 36 postoperative

• Percentage of Eyes With Sight-threatening Adverse Events (AEs)

  Up to Month 36 postoperative

• Percentage of Eyes With Ocular Secondary Surgical Interventions (SSI)

  Up to Month 36 postoperative

Study Arms (1)

CyPass System

EXPERIMENTAL

CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery

Device: CyPass Micro-Stent implanted with CyPass 241-S applier; Procedure: Cataract surgery

Interventions

CyPass Micro-Stent implanted with CyPass 241-S applier DEVICE

CyPass System (Model 241-S) consists of the CyPass Micro-Stent contained in a loading device (loader) and the CyPass applier.The CyPass Micro-Stent is an implantable medical device intended for long term use.

CyPass System

Cataract surgery PROCEDURE

Cataract surgery, followed by implantation of the CyPass Micro-Stent in one eye (the study eye) at the surgery visit

CyPass System

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand the requirements of the study and willing to follow study instructions, provide written informed consent, and agree to comply with all study requirements, including the required study follow-up visits
• Diagnosis of primary open angle glaucoma (POAG)
• Medicated intraocular pressure (IOP) of ≥10 millimeters mercury (mmHg) and ≤25 mmHg, or an unmedicated IOP of ≥21 mmHg and ≤33 mmHg
• An operable age-related cataract eligible for phacoemulsification
• Visual acuity as specified in the protocol

You may not qualify if:

• Inability to complete a visual field test prior to surgery
• Use of ocular hypotensive medication/s, as specified in the protocol
• Diagnosis of glaucoma other than POAG, as specified in the protocol
• Other medical conditions, as specified in the protocol
• Proliferative diabetic retinopathy
• Previous surgery for retinal detachment
• Previous corneal surgery
• Wet age-related macular degeneration
• Poor vision in the non-study eye not due to cataract
• Significant ocular inflammation or infection within 30 days of screening visit
• Uncontrolled systemic diseases that may put the subject's health at risk and/or prevent the subject from completing all study visits
• Women who are pregnant or nursing

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (20)

Alcon Investigative Site

Phoenix, Arizona, 85016, United States

Location

Alcon Investigative Site

Orange, California, 92868, United States

Location

Alcon Investigative Site

Fort Collins, Colorado, 80528, United States

Location

Alcon Investigative Site

Jacksonville, Florida, 32256, United States

Location

Alcon Investigative Site

Panama City, Florida, 32405, United States

Location

Alcon Investigative Site

Gainesville, Georgia, 30501, United States

Location

Alcon Investigative Site

Marietta, Georgia, 30060, United States

Location

Alcon Investigative Site

Garden City, Kansas, 67846, United States

Location

Alcon Investigative Site

Fraser, Michigan, 48026, United States

Location

Alcon Investigative Site

St Louis, Missouri, 63131, United States

Location

Alcon Investivative Site

St Louis, Missouri, 63141, United States

Location

Alcon Investigative Site

Vineland, New Jersey, 08361, United States

Location

Alcon Investigative Site

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Alcon Investigative Site

Chambersburg, Pennsylvania, 17201, United States

Location

Alcon Investigative Site

Austin, Texas, 78731, United States

Location

Alcon Investigative Site

El Paso, Texas, 79902, United States

Location

Alcon Investigative Site

Houston, Texas, 77030, United States

Location

Alcon Investigative Site

Bellevue, Washington, 98004-3012, United States

Location

Alcon Investigative Site

Kenosha, Wisconsin, 53142, United States

Location

Alcon Investigative Site

Racine, Wisconsin, 53405, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Limitations and Caveats

Considering the achieved sample size in this study (less than 10% of intended), no definitive conclusion can be made with respect to the rate of CyPass-related complications.

Results Point of Contact

• Title: CDMA Clinical Lead, Surgical
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Sr. Clinical Trial Lead, Surgical

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 6, 2017
• Study Start: October 12, 2017
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: February 16, 2024
• Results First Posted: September 21, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)