We conducted a retrospective consecutive case series assessing 12-month effectiveness and safety of iStent or iStent inject (Glaukos) trabecular microbypass implants with cataract surgery in patients with open-angle glaucoma (OAG) in a real-world clinical setting.
The effectiveness outcomes consisted of:
- IOP reduction;
- glaucoma medication reduction;
- proportions of eyes achieving IOP < 18, < 15, or < 12 mm Hg;
- proportional analysis of medication usage; and
- safety outcomes included adverse events, secondary surgeries, and best-corrected visual acuity (BCVA).
This evaluation included 58 eyes with OAG (35 iStent, 23 iStent inject), with > 96% of eyes having mild or moderate glaucoma. Diagnoses included primary OAG (the majority), pseudoexfoliative glaucoma, and pigmentary glaucoma.
The results were as follows:
- Baseline mean IOP and medications were statistically comparable between groups: 16.1 ± 3.6 mm Hg on a mean of 1.8 ± 0.8 medications in the iStent group and 16.2 ± 3.1 mm Hg on a mean of 1.7 ± 0.8 medications in the iStent inject group.
- Twelve months after stent-cataract surgery mean IOP was significantly lower in the iStent inject group than in the iStent group (13.1 mm Hg vs 15.4 mm Hg, respectively; P < .001), and the percent reduction in IOP from baseline was significantly greater in iStent inject eyes than in iStent eyes (19.1 vs 4.3% reduction, respectively; P <.001).
- At 12 months postoperative, significantly greater proportions of iStent inject eyes than iStent eyes achieved IOP < 18 mm Hg (100 vs 80.0% of eyes, respectively; P = .035), IOP < 15 mm Hg (73.9 vs 34.3% of eyes, respectively; P = .003), and IOP < 12 mm Hg (26.1 vs 0% of eyes, respectively; P = .002).
- Both groups achieved significant medication reductions at 12 months versus baseline (94.1% reduction in iStent inject eyes, P < .0001; and 72.2% reduction in iStent eyes, P < .0001), with the percent reduction being significantly greater in iStent inject eyes than in iStent eyes (P = .023).
- At 12 months mean number of medications was significantly lower in iStent inject eyes than iStent eyes (0.1 vs 0.5 medications, respectively; P = .021), and 95.7% of iStent inject eyes versus 71.4% of iStent eyes were off medications entirely.
- A similarly high safety profile was observed in both groups.
iStent or iStent inject implantation with cataract surgery resulted in substantial and safe reductions in IOP and medications through 12 months postoperative. Consistent with prior observations, greater efficacy was observed with iStent inject than with iStent.