Clinical trial NCT03273907: Post Approval Study of the CyPass System
Official title: Post Approval Study of the CyPass System in Patients With Primary Open Angle Glaucoma Undergoing Cataract Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Primary Open-angle Glaucoma
Cataract
Keywords: CyPass Micro-Stent
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2017-09-06
Enrollment: 79
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Detailed description: Each subject's expected participation in the study is up to 37.5 months which includes up to 42 days between the screening and surgery visits, and 36 months of post-surgery follow-up. Only one eye per subject will be implanted.

Eligibility criteria: Inclusion Criteria:

* 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
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* 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
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Eyes With Clinically Relevant Complications Associated With CyPass Micro-Stent Placement and Stability as Determined at Month 36
timeFrame: Up to Month 36 postoperative
Secondary outcomes:
measure: Mean Change in IOP From Baseline at Month 36
timeFrame: Baseline, Month 36 postoperative
measure: 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
timeFrame: Baseline, Month 36 postoperative
measure: Percentage of Eyes Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg at Month 36
timeFrame: Month 36 postoperative
measure: Percentage of Eyes With Sight-threatening Adverse Events (AEs)
timeFrame: Up to Month 36 postoperative
measure: Percentage of Eyes With Ocular Secondary Surgical Interventions (SSI)
timeFrame: Up to Month 36 postoperative
measure: Percentage of Eyes With Ocular SSIs Associated With CyPass Placement and Stability
timeFrame: Up to Month 36 postoperative
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Alcon Investigative Site
state: Arizona
city: Orange
country: United States
facility: Alcon Investigative Site
state: California
city: Fort Collins
country: United States
facility: Alcon Investigative Site
state: Colorado
city: Jacksonville
country: United States
facility: Alcon Investigative Site
state: Florida
city: Panama City
country: United States
facility: Alcon Investigative Site
state: Florida
city: Gainesville
country: United States
facility: Alcon Investigative Site
state: Georgia
city: Marietta
country: United States
facility: Alcon Investigative Site
state: Georgia
city: Garden City
country: United States
facility: Alcon Investigative Site
state: Kansas
city: Fraser
country: United States
facility: Alcon Investigative Site
state: Michigan
city: Saint Louis
country: United States
facility: Alcon Investigative Site
state: Missouri
city: Saint Louis
country: United States
facility: Alcon Investivative Site
state: Missouri
city: Vineland
country: United States
facility: Alcon Investigative Site
state: New Jersey
city: Bala-Cynwyd
country: United States
facility: Alcon Investigative Site
state: Pennsylvania
city: Chambersburg
country: United States
facility: Alcon Investigative Site
state: Pennsylvania
city: Austin
country: United States
facility: Alcon Investigative Site
state: Texas
city: El Paso
country: United States
facility: Alcon Investigative Site
state: Texas
city: Houston
country: United States
facility: Alcon Investigative Site
state: Texas
city: Bellevue
country: United States
facility: Alcon Investigative Site
state: Washington
city: Kenosha
country: United States
facility: Alcon Investigative Site
state: Wisconsin
city: Racine
country: United States
facility: Alcon Investigative Site
state: Wisconsin
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Clinical Trial Lead, Surgical
role: STUDY_DIRECTOR
References: