Coexistent primary open-angle glaucoma and cataract: interim analysis of a trabecular micro-bypass stent and concurrent cataract surgery.
OBJECTIVE
To evaluate the safety and efficacy of the iStent Trabecular Micro-bypass Stent in patients undergoing concurrent cataract and glaucoma surgery.


METHODS
Prospective, 24-month, uncontrolled, multicenter, multicountry evaluation of 58 patients with uncontrolled primary open-angle glaucoma (including pseudoexfoliation and pigmentary) and cataract. Patients underwent clear cornea phacoemulsification followed by ab interno gonioscopically guided implantation of the iStent. Of the 48 per protocol population, 42 patients completed 12 months of the 24-month study, and their data are included in this interim analysis.


RESULTS
At baseline, mean (+/-SD) intraocular pressure (IOP) was 21.7+/-3.98 mmHg. At 12 months, mean IOP was reduced to 17.4+/-2.99 mmHg, a mean IOP reduction of 4.4+/-4.54 mmHg (p<0.001, 18.3%). At baseline, patients were taking a mean 1.6+/-0.8 medications. By 12 months, the mean number of medications was reduced to 0.4+/-0.62 (p<0.001). Half the patients achieved an IOP < or =18 mmHg and were able to discontinue hypotensive medication by the 12-month visit. The most commonly reported device-related adverse events were the appearance of stent lumen obstruction (7 eyes) and stent malposition (6 eyes). None of the adverse events were deemed serious.


CONCLUSIONS
In patients undergoing concurrent cataract and glaucoma surgery, the iStent was safe and efficacious for the reduction of IOP and medication therapy.
Spiegel
Detlev
D
Klinik Vincentinum, Augsburg, Germany. detlev.spiegel@klinik.uni-regensburg.de
Wetzel
Wolfgang
W
Neuhann
Thomas
T
Stuermer
Jorg
J
Hoeh
Helmut
H
Garcia-Feijoo
Julian
J
Martinez-De-La-Casa
José Maria
JM
Garcia-Sanchez
Julian
J
D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage; D002386:Cataract / Q000150:complications / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D020327:Glaucoma Drainage Implants; D005902:Glaucoma, Open-Angle / Q000150:complications / Q000601:surgery*; D006068:Gonioscopy; D006493:Heparin; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D019654:Lens Implantation, Intraocular; D008297:Male; D018918:Phacoemulsification / Q000379:methods*; D011446:Prospective Studies; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology
D000959:Antihypertensive Agents; D006493:Heparin