NCT04629521

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Open Angle Glaucoma
• Cataract

Interventions

Type	Name	Description
DEVICE	CyPass Micro-Stent	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.
PROCEDURE	Cataract Surgery	Cataract surgery involves the removal of the natural lens, which has become clouded (called a cataract), and insertion of an artificial lens (called an intraocular lens). This procedure is done through a small surgical incision in the eye.

Timeline

• Start date: 2020-12-21
• Primary completion: 2023-04-05
• Completion: 2023-04-05
• First posted: 2020-11-16
• Last updated: 2024-04-26
• Results posted: 2024-04-26

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated device study