Clinical trial NCT04629521: Additional Long-Term Follow-up for Subjects Implanted With a CyPass® Micro-Stent
Official title: An Observational Multicenter Clinical Study to Provide Additional Long-Term Follow-up Beyond 60 Months for Subjects Implanted With a CyPass Micro-Stent in the COMPASS Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma
Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2020-11-16
Enrollment: 54
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess long-term (10 years post-CyPass implantation) status of the corneal endothelium in subjects who were implanted with the CyPass Micro-Stent in the COMPASS trial.

Detailed description: The COMPASS Trial (TMI-09-01/NCT01085357) was a prospective, randomized, comparative multicenter study to assess the safety and effectiveness of the CyPass Micro-Stent in subjects with primary open angle glaucoma who were undergoing cataract surgery. In the COMPASS Trial, 374 subjects undergoing cataract surgery were randomized to the CyPass group and received the CyPass Micro-Stent, whereas 131 subjects underwent cataract surgery alone. All subjects were to be followed for 2 years postoperatively. Four hundred eighty (480) subjects completed this study.

The COMPASS XT Trial (TMI-09-01E/GLD122b-C001/NCT02700984) was designed to collect safety data beyond 24 months postoperatively for subjects who completed the COMPASS Trial. In COMPASS-XT, clinical data was collected at 36 months, 48 months, and 60 months postoperatively for a total of 5-year follow-up across the 2 studies.

In this trial, COMPASS XXT, clinical data will be collected annually for the subjects who were implanted with the CyPass Micro-Stent in the COMPASS TRIAL until the subject reaches 10 years post-CyPass implantation. For some subjects, the first visit will be at or after 10 years post-CyPass implantation, and therefore the first visit may coincide with the Exit visit.

Eligibility criteria: Key Inclusion Criteria:

* Implantation with a CyPass Micro-Stent as a participant in the COMPASS trial (NCT01085357) (Transcend Medical, Incorporated, Study Number TMI-09-01).
* 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.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Inability to comply with the protocol or required follow-up visit/procedures.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Eyes With Sight-threatening Adverse Events (AEs)
timeFrame: Month 96 (Year 8) to Month 120 (Year 10) postoperative
measure: Percentage of Eyes With Ocular Adverse Events
timeFrame: Month 96 (Year 8) to Month 120 (Year 10) postoperative
measure: Central Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation
timeFrame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Central Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval
timeFrame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Central Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8)
timeFrame: Month 96 (Year 8) postoperative
measure: Central Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9)
timeFrame: Month 108 (Year 9) postoperative
measure: Central Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10)
timeFrame: Month 120 (Year 10) postoperative
measure: Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation
timeFrame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval
timeFrame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8)
timeFrame: Month 96 (Year 8) postoperative
measure: Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9)
timeFrame: Month 108 (Year 9) postoperative
measure: Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10)
timeFrame: Month 120 (Year 10) postoperative
measure: Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Mean and Standard Deviation
timeFrame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 96 (Year 8)
timeFrame: Month 96 (Year 8) postoperative
measure: Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 108 (Year 9)
timeFrame: Month 108 (Year 9) postoperative
measure: Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 120 (Year 10)
timeFrame: Month 120 (Year 10) postoperative
measure: Central Endothelial Hexagonality (CEH) Reported by Mean and Standard Deviation
timeFrame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 96 (Year 8)
timeFrame: Month 96 (Year 8) postoperative
measure: Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 108 (Year 9)
timeFrame: Month 108 (Year 9) postoperative
measure: Central Endothelial Hexagonality Reported by Percentile - Month 120 (Year 10)
timeFrame: Month 120 (Year 10) postoperative
measure: Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation
timeFrame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval
timeFrame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8)
timeFrame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8) postoperative
measure: Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9)
timeFrame: Baseline (COMPASS Study) preoperative, Month 108 (Year 9) postoperative
measure: Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10)
timeFrame: Baseline (COMPASS Study) preoperative, Month 120 (Year 10) postoperative
measure: Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation
timeFrame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval
timeFrame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8)
timeFrame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8) postoperative
measure: Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9)
timeFrame: Baseline (COMPASS Study) preoperative, Month 108 (Year 9) postoperative
measure: Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10)
timeFrame: Baseline (COMPASS Study) preoperative, Month 120 (Year 10) postoperative
measure: Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared
timeFrame: Month 3, Month 6, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared
timeFrame: Month 3, Month 6, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline
timeFrame: Baseline (COMPASS Study) preoperative, Month 3, Month 6, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Percentage of Eyes According to Peripheral Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared
timeFrame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Percentage of Eyes According to Peripheral Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared
timeFrame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation
timeFrame: Baseline (COMPASS Study) preoperative, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval
timeFrame: Baseline (COMPASS Study) preoperative, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation
timeFrame: Baseline (COMPASS Study) preoperative, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval
timeFrame: Baseline (COMPASS Study) preoperative, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Number of Corneal Sequelae Events Associated With Endothelial Cell Loss (ECL)
timeFrame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation
timeFrame: Month 3, Month 6, Month 12 (Year 1), Month 24 (Year 2), Month 36 (Year 3), Month 48 (Year 4), Month 60 (Year 5), Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10)
measure: Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3
timeFrame: Month 3 postoperative
measure: Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6
timeFrame: Month 6 postoperative
measure: Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1)
timeFrame: Month 12 (Year 1) postoperative
measure: Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2)
timeFrame: Month 24 (Year 2) postoperative
measure: Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3)
timeFrame: Month 36 (Year 3) postoperative
measure: Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4)
timeFrame: Month 48 (Year 4) postoperative
measure: Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5)
timeFrame: Month 60 (Year 5) postoperative
measure: Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8)
timeFrame: Month 96 (Year 8) postoperative
measure: Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9)
timeFrame: Month 108 (Year 9) postoperative
measure: Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10)
timeFrame: Month 120 (Year 10) postoperative
measure: Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation
timeFrame: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8)
timeFrame: Month 96 (Year 8) postoperative
measure: Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9)
timeFrame: Month 108 (Year 9) postoperative
measure: Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10)
timeFrame: Month 120 (Year 10) postoperative
measure: Number of Secondary Surgical Intervention (SSI) Events to Modify the Device Position (eg, Repositioning, Trimming, Explantation)
timeFrame: Month 96 (Year 8) to Month 120 (Year 10) postoperative
measure: Percentage of Eyes With CyPass Micro-Stent Movement and/or Malposition
timeFrame: Month 96 (Year 8) to Month 120 (Year 10) postoperative
measure: Number of Corneal Adverse Events Caused by CyPass MicroStent
timeFrame: Month 96 (Year 8) to Month 120 (Year 10) postoperative
measure: Number of Events of Best Corrected Visual Acuity (BCVA) Loss of 10 Letters or More
timeFrame: Month 96 (Year 8) to Month 120 (Year 10) postoperative
measure: Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported by Mean and Standard Deviation
timeFrame: Screening (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Percentage of Eyes With Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported Categorically - 2 Decibel (dB)
timeFrame: Screening (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Change in Central Corneal Thickness (CCT) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation
timeFrame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
measure: Change in Central Corneal Thickness (CCT) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval
timeFrame: Baseline (COMPASS Study) preoperative, Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Eye Physicians and Surgeons of Arizona
state: Arizona
city: Orange
country: United States
facility: Coastal Vision Medical Group
state: California
city: Fort Collins
country: United States
facility: Eye Center of Northern Colorado, PC
state: Colorado
city: Cape Coral
country: United States
facility: Cape Coral Eye Center
state: Florida
city: Sioux City
country: United States
facility: Jones Eye Center PC
state: Iowa
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Vineland
country: United States
facility: Eye Associates and SurgiCenter of Vineland
state: New Jersey
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: West Mifflin
country: United States
facility: Associates In Ophthalmology Ltd.
state: Pennsylvania
city: Maryville
country: United States
facility: University Eye Specialists
state: Tennessee
city: Nashville
country: United States
facility: The Vanderbilt Eye Institute
state: Tennessee
city: Fort Worth
country: United States
facility: Ophthalmology Associates
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Operations Lead, Surgical
role: STUDY_DIRECTOR
References: