Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract.
OBJECTIVE
To assess the safety and efficacy of the iStent trabecular micro-bypass stent (Glaukos Corporation, Laguna Hills, CA) in combination with cataract surgery in subjects with mild to moderate open-angle glaucoma.


METHODS
Prospective, randomized, open-label, controlled, multicenter clinical trial.


METHODS
A total of 240 eyes with mild to moderate open-angle glaucoma with intraocular pressure (IOP) ≤24 mmHg controlled on 1 to 3 medications were randomized to undergo cataract surgery with iStent implantation (treatment group) or cataract surgery only (control). Fifty additional subjects were enrolled to undergo cataract surgery with iStent implantation under protocol expansion. Data in this report are based on the first 240 eyes enrolled.


METHODS
Implantation of the iStent trabecular micro-bypass stent in conjunction with cataract surgery or cataract surgery only.


METHODS
The primary efficacy measure was unmedicated IOP ≤21 mmHg at 1 year. A secondary measure was unmedicated IOP reduction ≥20% at 1 year. Safety measures included best-corrected visual acuity (BCVA), slit-lamp observations, complications, and adverse events.


RESULTS
The study met the primary outcome, with 72% of treatment eyes versus 50% of control eyes achieving the criterion (P<0.001). At 1 year, IOP in both treatment groups was statistically significantly lower from baseline values. Sixty-six percent of treatment eyes versus 48% of control eyes achieved ≥20% IOP reduction without medication (P = 0.003). The overall incidence of adverse events was similar between groups with no unanticipated adverse device effects.


CONCLUSIONS
Pressure reduction on fewer medications was clinically and statistically significantly better 1 year after stent plus cataract surgery versus cataract surgery alone, with an overall safety profile similar to that of cataract surgery alone.
Samuelson
Thomas W
TW
Minnesota Eye Consultants, Minneapolis, Minnesota, USA.
Katz
L Jay
LJ
Wells
Jeffrey M
JM
Duh
Yi-Jing
YJ
Giamporcaro
Jane Ellen
JE
D000368:Aged; D001082:Aqueous Humor / Q000378:metabolism; D002386:Cataract / Q000150:complications*; D005260:Female; D005902:Glaucoma, Open-Angle / Q000150:complications / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D007440:Intubation / Q000379:methods; D019654:Lens Implantation, Intraocular; D008297:Male; D018918:Phacoemulsification; D011446:Prospective Studies; D015607:Stents; D014065:Tonometry, Ocular; D014129:Trabecular Meshwork / Q000601:surgery*; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology