Introduction  

Reducing intraocular pressure (IOP) is the only proven treatment modality for reducing the risk of glaucomatous progression. In this study, we evaluated the safety and efficacy of a new tool in IOP reduction, implanted with cataract surgery: the Glaukos iStent trabecular micro-bypass stent.

Methods  

This was a prospective, 24-month, uncontrolled, non-randomised, multicentre study. Subjects with uncontrolled primary open-angle glaucoma (including pseudoexfoliation and pigmentary) and a cataract underwent clear cornea phacoemulsification cataract extraction with ab-interno gonioscopically guided implantation of the study stent. Subjects who had completed at least 6 months of follow-up were included in this interim analysis (n=47).

Results  

At baseline, mean (±standard deviation) IOP was 21.5±3.7 mmHg, and subjects were taking a mean of 1.5±0.7 ocular hypotensive medications. Six months after implantation of the study stent the mean IOP was 15.8± 3.0 mmHg, a mean IOP reduction of 5.7±3.8 mmHg (25.4%, P<0.001). The mean number of patient medications after 6 months was 0.5±0.8 medications, a mean decrease of 1.0±0.8 medications (66.7%, P<0.001). Most subjects (70%) were able to discontinue all glaucoma medications. There were no complications traditionally associated with filtering surgery, and no serious adverse events were reported.

Conclusion  

In this interim analysis of subjects with glaucoma and cataracts, this novel stent implantation in subjects undergoing cataract surgery represents a new surgical approach to provide clinically significant decreases in IOP and drug burden.