Additional Long-Term Follow-up for Subjects Implanted With a CyPass® Micro-Stent (COMPASS XXT)
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About
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.
Full 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.
Enrollment
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Inclusion and exclusion 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
54 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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