Supraciliary Micro-stent Implantation for Open-Angle Glaucoma Failing Topical Therapy: 1-Year Results of a Multicenter Study.
OBJECTIVE
To evaluate the safety and efficacy of a supraciliary micro-stent (CyPass Micro-Stent; Transcend Medical, Menlo Park, California, USA) for surgical treatment of glaucoma in patients refractory to topical medications.


METHODS
Multicenter, single-arm interventional study.


METHODS
Patients with open-angle glaucoma (Shaffer Grade 3 and 4) and uncontrolled medicated intraocular pressure (IOP) >21 mm Hg at baseline and candidates for conventional glaucoma surgery were enrolled. Glaucoma medications were discontinued at surgery and resumed at investigator discretion. CyPass Micro-Stent implantation was completed in all patients using a standard clear corneal approach. Adverse events, postoperative IOP changes, and need for IOP-lowering medications during the first 12 postoperative months (12M) were monitored.


RESULTS
Sixty-five eyes were enrolled, and 55 were available at 12M, accounting for loss to follow-up and early termination. Baseline IOP was 24.5 ± 2.8 mm Hg, and the mean number of medications recorded was 2.2 ± 1.1. There were no serious intraoperative events or major adverse events (eg, retinal or choroidal detachment, persistent uveitis, persistent hyphema, hypotony maculopathy). The most common adverse events included IOP increases >30 mm Hg beyond 1 month (11%, 7/65), transient hyphema (6%, 4/65), and cataract progression (12%, 5/41 phakic eyes). Mean IOP was 16.4 ± 5.5 mm Hg at 12 months-a 34.7% reduction (P < .0001). Mean medication usage also decreased from baseline to a mean of 1.4 ± 1.3 medications at 12M (P = .002). In eyes originally indicated for conventional glaucoma surgery, no secondary surgery was performed in 83% (53/64).


CONCLUSIONS
Supraciliary stenting with the CyPass Micro-Stent effectively lowers IOP as a surgical treatment for glaucoma, precluding the need for more invasive glaucoma surgery in >80% of patients at 1 year, thereby reducing postoperative glaucoma surgical complications.
Instituto de Investigación, Biomedica Hospital Clinico San Carlos, UCM, Oftared, Madrid, Spain.
Julian
J
García-Feijoo
Eye Clinic, Cham, Germany.
Magda
M
Rau
University Clinic Schleswig-Holstein, Luebeck, Germany.
Swaantje
S
Grisanti
Eye Hospital, Luebeck, Germany.
Salvatore
S
Grisanti
Eye Hospital at the Dietrich-Bonhoeffer-Klinikum, Neubrandenburg, Germany; Teaching Hospital of the Ernst-Moritz-Arndt University of Greifswald, Greifswald, Germany.
Helmut
H
Höh
Eye Clinic Wittenbergplatz, Berlin, Germany.
Carl
C
Erb
Eye Clinic of Sofia, Sofia, Bulgaria.
Pravoslava
P
Guguchkova
University of Toronto, Toronto, Canada.
Iqbal
I
Ahmed
Paracelsus Medical University, Salzburg, Austria.
Günther
G
Grabner
Paracelsus Medical University, Salzburg, Austria.
Herbert
H
Reitsamer
University of Geneva, Geneva, Switzerland.
Tarek
T
Shaarawy
University of California at San Francisco, San Francisco, California. Electronic address: sianchulev@transcendmedical.com.
Tsontcho
T
Ianchulev
D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use; D002924:Ciliary Body / Q000601:surgery*; D005260:Female; D020327:Glaucoma Drainage Implants; D005902:Glaucoma, Open-Angle / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery*; D006068:Gonioscopy; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects / Q000502:physiology; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D019919:Prosthesis Implantation; D016037:Single-Blind Method; D015607:Stents; D014065:Tonometry, Ocular; D017211:Treatment Failure; D014792:Visual Acuity / Q000502:physiology
D000959:Antihypertensive Agents