Additional Long-Term Follow-up for Subjects Implanted With a CyPass® Micro-Stent

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Primary Open Angle Glaucoma, Cataract

Intervention / Treatment
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* Device: CyPass Micro-Stent


Participation Criteria
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Eligibility Criteria
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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. Key Exclusion Criteria: - Inability to comply with the protocol or required follow-up visit/procedures.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CyPass Micro-Stent<br>CyPass Micro-Stent placed in the angle of the eye at the conclusion of cataract surgery (COMPASS trial) | Device: CyPass Micro-Stent<br>* The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front into the back of the eye. The device is implanted after completion of cataract surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of occurrence of sight-threatening adverse events (AEs) | This analysis will be performed using data from visits in the COMPASS XXT study. Sight-threatening adverse events as specified in the protocol will be reported as a percentage of eyes with a 2-sided exact 95 percent confidence interval for each. | Up to Year 10 postoperative | 
| Rate of occurrence of ocular AEs | This analysis will be performed using data from visits in the COMPASS XXT study. Ocular adverse events will be reported as a percentage of eyes with a 2-sided exact 95 percent confidence interval for each. | Up to Year 10 postoperative | 
| Central Endothelial Cell Density (ECD) reported by mean and standard deviation | This analysis will be performed using data from visits in the COMPASS XXT study. | Up to Year 10 postoperative | 
| Central ECD reported by mean and 95 percent confidence interval | This analysis will be performed using data from visits in the COMPASS XXT study. | Up to Year 10 postoperative | 
| Central ECD reported by percentile | This analysis will be performed using data from visits in the COMPASS XXT study. | Up to Year 10 postoperative | 
| Peripheral ECD reported by mean and standard deviation | This analysis will be performed using data from visits in the COMPASS XXT study. | Up to Year 10 postoperative | 
| Peripheral ECD reported by mean and 95 percent confidence interval | This analysis will be performed using data from visits in the COMPASS XXT study. | Up to Year 10 postoperative | 
| Peripheral ECD reported by percentile | This analysis will be performed using data from visits in the COMPASS XXT study. | Up to Year 10 postoperative | 
| Central Endothelial Cell Coefficient of Variation reported by mean and standard deviation | This analysis will be performed using data from visits in the COMPASS XXT study. | Up to Year 10 postoperative | 
| Central Endothelial Cell Coefficient of Variation reported by percentile | This analysis will be performed using data from visits in the COMPASS XXT study. | Up to Year 10 postoperative | 
| Central Endothelial Hexagonality reported by mean and standard deviation | This analysis will be performed using data from visits in the COMPASS XXT study. | Up to Year 10 postoperative | 
| Central Endothelial Hexagonality reported by percentile | This analysis will be performed using data from visits in the COMPASS XXT study. | Up to Year 10 postoperative | 
| Change in Central ECD from COMPASS Trial Baseline Visit reported by mean and standard deviation | This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available. | COMPASS Trial Baseline Visit, up to Year 10 postoperative | 
| Change in Central ECD from COMPASS Trial Baseline Visit reported by mean and confidence interval | This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available. | COMPASS Trial Baseline Visit, up to Year 10 postoperative | 
| Change in Central ECD from COMPASS Trial Baseline Visit reported by percentile | This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available. | COMPASS Trial Baseline Visit, up to Year 10 postoperative | 
| Percent change in central ECD from COMPASS Trial Baseline Visit reported by mean and standard deviation | This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available. | COMPASS Trial Baseline Visit, up to Year 10 postoperative | 
| Percent change in central ECD from COMPASS Trial Baseline Visit reported by mean and 95% confidence interval | This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available. | COMPASS Trial Baseline Visit, up to Year 10 postoperative | 
| Percent change in central ECD from COMPASS Trial Baseline Visit reported by percentile | This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available. | COMPASS Trial Baseline Visit, up to Year 10 postoperative | 
| Percentage of Eyes According to Central Endothelial Cell Density <1000 cells per millimeter squared | This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available. Percentage of eyes with a 2-sided exact 95 percent confidence interval will be reported. | Up to Year 10 postoperative | 
| Percentage of Eyes According to Central Endothelial Cell Density <500 cells per millimeter squared | This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available. Percentage of eyes with a 2-sided exact 95 percent confidence interval will be reported. | Up to Year 10 postoperative | 
| Percentage of Eyes According to Central Endothelial Percent Change from COMPASS Trial Baseline >30% Loss | This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available. | COMPASS Trial Baseline Visit, up to Year 10 postoperative | 
| Percentage of Eyes According to Peripheral Endothelial Cell Density <1000 cells per millimeter squared | This analysis will be performed using data from visits in the COMPASS XXT study. Percentage of eyes with a 2-sided exact 95 percent confidence interval will be reported. | Up to Year 10 postoperative | 
| Percentage of Eyes According to Peripheral Endothelial Cell Density <500 cells per millimeter squared | This analysis will be performed using data from visits in the COMPASS XXT study. Percentage of eyes with a 2-sided exact 95 percent confidence interval will be reported. | Up to Year 10 postoperative | 
| Annualized rate of change in Central Endothelial Cell Density at each year of observation reported by mean and standard deviation | This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available. | Up to Year 10 postoperative | 
| Annualized rate of change in Central Endothelial Cell Density at each year of observation reported by mean and 95 percent confidence interval | This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available. | Up to Year 10 postoperative | 
| Annualized percent rate of change in Central Endothelial Cell Density at each year of observation reported by mean and standard deviation | This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available. | Up to Year 10 postoperative | 
| Annualized percent rate of change in Central Endothelial Cell Density at each year of observation reported by mean and 95 percent confidence interval | This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available. | Up to Year 10 postoperative | 
| Number of corneal sequelae events associated with Endothelial Cell Loss (ECL) | This analysis will be performed using data from visits in the COMPASS XXT study. | Up to Year 10 postoperative | 
| Central ECD Count by Number of Rings Observed at the Visit reported by mean and standard deviation | This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available. Only data for subjects with rings and ECD data will be presented. | Up to Year 10 postoperative | 
| Central ECD Count by Number of Rings Observed at the Visit reported by percentile | This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available. Only data for subjects with rings and ECD data will be presented. | Up to Year 10 postoperative | 
| Peripheral ECD Count by Number of Rings Observed at the Visit reported by mean and standard deviation | This analysis will be performed using data from visits in the COMPASS XXT study. Only data for subjects with rings and ECD data will be presented. | Up to Year 10 postoperative | 
| Peripheral ECD Count by Number of Rings Observed at the Visit reported by percentile | This analysis will be performed using data from visits in the COMPASS XXT study. Only data for subjects with rings and ECD data will be presented. | Up to Year 10 postoperative | 
| Number of Secondary Surgical Intervention (SSI) events to modify the device position (eg, repositioning, trimming, explantation) | This analysis will be performed using data from visits in the COMPASS XXT study. | Up to Year 10 postoperative | 
| CyPass Micro-Stent movement and/or malposition | This analysis will be performed using data from visits in the COMPASS XXT study. CyPass Micro-Stent movement and/or malposition will be reported as a percentage of eyes with a 2-sided exact 95 percent confidence interval. | Up to Year 10 postoperative | 
| Number of corneal adverse events caused by CyPass MicroStent | This analysis will be performed using data from visits in the COMPASS XXT study. | Up to Year 10 postoperative | 
| Number of events of Best Corrected Visual Acuity (BCVA) loss of 10 letters or more | This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available. | COMPASS Trial Screening Visit, up to Year 10 postoperative | 
| Change in visual field mean deviation from COMPASS Trial Screening Visit reported by mean and standard deviation | This analysis will be performed using data from visits COMPASS XXT study. | COMPASS Trial Screening Visit, up to Year 10 postoperative | 
| Change in visual field mean deviation from COMPASS Trial Screening Visit reported categorically | This analysis will be performed using data from visits COMPASS XXT study. | COMPASS Trial Screening Visit, up to Year 10 postoperative | 
| Change in central corneal thickness from COMPASS Trial Screening Visit reported by mean and standard deviation | This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available. | COMPASS Trial Screening Visit, up to Year 10 postoperative | 
| Change in central corneal thickness from COMPASS Trial Screening Visit reported by mean and confidence interval | This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available. | COMPASS Trial Screening Visit, up to Year 10 postoperative |