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

  • End date
    Aug 1, 2023
  • participants needed
  • sponsor
    Alcon Research
Updated on 1 May 2021


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.

Condition Cataract, Cataracts, Glaucoma, Glaucoma, Pigmentary glaucoma, Open Angle Glaucoma, Primary Open Angle Glaucoma, Cataracts, Open Angle Glaucoma
Treatment CyPass Micro-Stent
Clinical Study IdentifierNCT04629521
SponsorAlcon Research
Last Modified on1 May 2021


Yes No Not Sure

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

Exclusion Criteria

Inability to comply with the protocol or required follow-up visit/procedures
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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