CompletedNot Applicable

Safety and Performance Study of the CyPass System Applier Model 241

Germany172 participantsStarted 2014-08

Plain-language summary

This is a retrospective chart review of cases in which the CyPass Micro-Stent was implanted using the Model 241 Applier. The objective of this study is to characterize and evaluate the safety of the Model 241 Applier when used for CyPass Micro-Stent implantation.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. Diagnosis of OAG
✓. CyPass Micro-Stent implantation (using the CyPass system 241) following uncomplicated phacoemulsification cataract removal and intraocular lens implantation

Exclusion criteria

✕. Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
✕. Prior incisional glaucoma surgery

What they're measuring

Ocular adverse events in the study eye

Timeframe: Intraoperatively though the first 3 postoperative months

Trial details

NCT IDNCT02228577

SponsorTranscend Medical, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-10

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