Format

Send to

Choose Destination
Ophthalmology. 2019 Jun;126(6):811-821. doi: 10.1016/j.ophtha.2019.03.006. Epub 2019 Mar 14.

Prospective, Randomized, Controlled Pivotal Trial of an Ab Interno Implanted Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract: Two-Year Results.

Author information

1
Minnesota Eye Consultants, Minneapolis, Minnesota. Electronic address: twsamuelson@mneye.com.
2
Dean McGee Eye Institute, Oklahoma City, Oklahoma.
3
Arbor Centers for EyeCare, Homewood, Illinois.
4
Stiles Eyecare Excellence and Glaucoma Institute PA, Overland Park, Kansas.
5
StatServ Consulting Inc, Chino Hills, California.
6
ClinReg Consulting Services, Laguna Beach, California.
7
Glaukos Corporation, San Clemente, California.
8
Glaukos Corporation, San Clemente, California; Wills Eye Hospital, Philadelphia, Pennsylvania.

Abstract

PURPOSE:

Evaluate the safety and effectiveness of an ab interno implanted (iStent inject) Trabecular Micro-Bypass System (Glaukos Corporation, San Clemente, CA) in combination with cataract surgery in subjects with mild to moderate primary open-angle glaucoma (POAG).

DESIGN:

Prospective, randomized, single-masked, concurrently controlled, multicenter clinical trial.

PARTICIPANTS:

Eyes with mild to moderate POAG and preoperative intraocular pressure (IOP) ≤24 mmHg on 1 to 3 medications, unmedicated diurnal IOP (DIOP) 21 to 36 mmHg, and cataract requiring surgery.

METHODS:

After uncomplicated cataract surgery, eyes were randomized 3:1 intraoperatively to ab interno implantation of iStent inject (Model G2-M-IS; treatment group, n = 387) or no stent implantation (control group, n = 118). Subjects were followed through 2 years postoperatively. Annual washout of ocular hypotensive medication was performed.

MAIN OUTCOME MEASURES:

Effectiveness end points were ≥20% reduction from baseline in month 24 unmedicated DIOP and change in unmedicated month 24 DIOP from baseline. Safety measures included best spectacle-corrected visual acuity (BSCVA), slit-lamp and fundus examinations, gonioscopy, pachymetry, specular microscopy, visual fields, complications, and adverse events.

RESULTS:

The groups were well balanced preoperatively, including medicated IOP (17.5 mmHg in both groups) and unmedicated DIOP (24.8±3.3 mmHg vs. 24.5±3.1 mmHg in the treatment and control groups, respectively, P = 0.33). At 24 months, 75.8% of treatment eyes versus 61.9% of control eyes experienced ≥20% reduction from baseline in unmedicated DIOP (P = 0.005), and mean reduction in unmedicated DIOP from baseline was greater in treatment eyes (7.0±4.0 mmHg) than in control eyes (5.4±3.7 mmHg; P < 0.001). Of the responders, 84% of treatment eyes and 67% of control eyes were not receiving ocular hypotensive medication at 23 months. Furthermore, 63.2% of treatment eyes versus 50.0% of control eyes had month 24 medication-free DIOP ≤18 mmHg (difference 13.2%; 95% confidence interval, 2.9-23.4). The overall safety profile of the treatment group was favorable and similar to that in the control group throughout the 2-year follow-up.

CONCLUSIONS:

Clinically and statistically greater reductions in IOP without medication were achieved after iStent inject implantation with cataract surgery versus cataract surgery alone, with excellent safety through 2 years.

PMID:
30880108
DOI:
10.1016/j.ophtha.2019.03.006
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center