Abstract
Purpose: :
To investigateintraocular pressure lowering effect and safety of iStent trabecularmicro-bypass.
Methods: :
A prospective non-randamaized interventional study involving 10 patients with medically uncontrolled primary open angle glaucoma. One eye of each patient was eligible for the study. Patients were received ab interno two iStent insertion to the nasal quadrant of trabecular meshwork through temporal corneal incision. In all patient, the same medication as baseline was continued postoperatively. In all eyes, intraocular pressure (IOP) and the endothelial cell density (ECD) before and at 1, 3 and 6 months were measure, as well as best corrected visual acuity (BCVA) before and at 6 months after surgery.
Results: :
10 susjects were enrolled. All patients were treated three IOP lowering eye drops including prostaglandins, adrenergic receptor antagonists and carbonic anhydrase inhibitors. Nine patient completed follow-up at six month, one patient finished follow-upat two month and we lost the patient after two month vist. Since there was no IOP reduction in another eye, the eye started oral acetazolamide at one month visit and received trabeculectomy at four month. The eye was excluded from statistical analysis in IOP at two, three and six month visit and in ECD at six month visit.The mean baseline IOP was22.0 +/- 3.0 (range 18-28) mmHg (n=10). Postoperative IOP were 16.3 +/- 3.4 (range 10-21) mmHg at one month (p<0.05, n=10), 16.3+/- 4.1 (range 13-20) mmHg at two month (p<0.05, n=9), 16.9 +/- 2.9mmHg at three month (p<0.05, n=9), and 16.9 +/-3.6 (range 15-22) mmHg (n=9).ECD averaged 2506 +/- 570 cells/mm(2) preoperatively (n=9), 2465 +/- 562 cells/mm(2) at one month (n=7), 2465 +/- 562 cells/mm(2) at three months (n=7), and 2556 +/-577 at six months after surgery (n=7). No statistically significant changes in ECD were noted.
Conclusions: :
iStent redued IOP statistically significanly, and there was no adverse effect to BCVA and corneal endothelium cell.
Clinical Trial: :
UMIN-CTR, UMIN000004002
Keywords: trabecular meshwork • aqueous