Two-year clinical experience with the CyPass micro-stent: safety and surgical outcomes of a novel supraciliary micro-stent.
OBJECTIVE
The aim of this study was to evaluate through 2 postoperative years the clinical outcomes associated with a novel supraciliary micro-stent for the surgical treatment of open-angle glaucoma (OAG) when implanted in conjunction with cataract surgery.


METHODS
In a multicenter, prospective, consecutive case series, 136 subjects (136 eyes) with OAG and requiring cataract surgery with 24-month postoperative data were included. A combined phacoemulsification procedure, with intraocular lens insertion and CyPass Micro-Stent implantation into the supraciliary space of the study eye, was performed. At baseline, all subjects were on glaucoma medication with either uncontrolled intraocular pressure (IOP; ≥ 21 mmHg, Cohort 1, n=51) or controlled IOP (<21 mmHg, Cohort 2, n=85). Glaucoma medications were stopped postoperatively, but could be restarted if needed, at the investigator's discretion. Device-related adverse events, postoperative IOP, best corrected distance visual acuity (BCDVA), and number of IOP-lowering medications were recorded.


RESULTS
The micro-stent was successfully implanted in all eyes. At 24 months, 82 subjects remained in the study. No sight-threatening adverse events occurred. The most common adverse events were transient hypotony (15.4%) and micro-stent obstruction (8.8%), typically due to iris tissue overgrowth. Fifteen subjects (11%) required secondary incisional glaucoma surgery. For Cohort 1 (n=23), mean ± SD IOP was 15.8 ± 3.8 mmHg after 24 months (change, -37% ± 19%). Mean IOP decrease from baseline was statistically significant (p<0.0001) at months 6, 12, and 24. For Cohort 2 (n=59), mean ± SD IOP at 24 months was 16.1 ± 3.2 mmHg (change, 0% ± 28%). Mean decrease from baseline was statistically significant at months 6 (p=0.0188) and 12 (p=0.0356). At 24 months, the mean ± SD number of medications was 1.0 ± 1.1 in Cohort 1 and 1.1 ± 1.1 in Cohort 2. Mean decrease from baseline medication use was statistically significant at months 6 (p<0.001), 12 (p<0.001), and 24 (p=0.0265) in Cohort 1, and at months 6, 12, and 24 (all p<0.0001) in Cohort 2.


CONCLUSIONS
CyPass Micro-Stent implantation, in combination with cataract surgery, was associated with minimal complications while substantially lowering IOP and/or use of IOP-lowering medications.
Klinik für Augenheilkunde, Dietrich-Bonhoeffer-Klinikum (Chairman: Prof. Dr. med. Helmut Höh), Neubrandenburg.
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Höh
Augenklinik der Medizinischen Akademie (Chairman: Prof. Dr. med. Salvatore Grisanti), Lübeck.
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Grisanti
Augenklinik der Medizinischen Akademie (Chairman: Prof. Dr. med. Salvatore Grisanti), Lübeck.
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Grisanti
Augenärztin, Furth im Wald.
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M
Rau
Clinical Associate Professor, UCSF, Transcend Medical, Inc., Menlo Park, CA, USA.
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Ianchulev
D000368:Aged; D002387:Cataract Extraction / Q000379:methods*; D003131:Combined Modality Therapy; D019544:Equipment Failure Analysis; D005260:Female; D005858:Germany; D020327:Glaucoma Drainage Implants / Q000009:adverse effects*; D005902:Glaucoma, Open-Angle / Q000175:diagnosis / Q000601:surgery*; D006801:Humans; D019654:Lens Implantation, Intraocular / Q000379:methods*; D008137:Longitudinal Studies; D008297:Male; D008904:Miniaturization; D011474:Prosthesis Design; D015607:Stents / Q000009:adverse effects*; D016896:Treatment Outcome