Additional Long-Term Follow-up for Subjects Implanted With a CyPass® Micro-Stent (COMPASS XXT)

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

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.

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.

CyPass Micro-Stent placed in the angle of the eye at the conclusion of cataract surgery (COMPASS trial)

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.

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.

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.

This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available.

This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available.

This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available.

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.

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.

This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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. CyPass Micro-Stent movement and/or malposition will be reported as a percentage of eyes with a 2-sided exact 95 percent confidence interval.

This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available.

Change in visual field mean deviation from COMPASS Trial Screening Visit reported by mean and standard deviation

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.

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.

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.