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Two-year safety data for investigational trabecular bypass stent comparable to phaco alone
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 Jonathan S. Myers |
DANA POINT, Calif. — In a study comparing iStent plus phaco vs. phaco alone, 24-month data show the two groups to be comparable in regard to safety, a speaker said here.
Regarding best corrected visual acuity, "No matter how you break the data down, certainly I don't see any evidence here to suggest that the iStent fared worse than the phaco-alone group," Jonathan S. Myers, MD, said at the American Glaucoma Society meeting.
The U.S. Food and Drug Association has not approved the iStent Trabecular Micro-Bypass (Glaukos) for commercial use, and it is an investigational device in the U.S. The proposed indication for iStent is use in conjunction with cataract surgery to reduce IOP in subjects on ocular hypotensive medication for mild to moderate open-angle glaucoma, Dr. Myers said. Having mild to moderate open-angle glaucoma was among the inclusion criteria for the 240 subjects in this multicenter prospective randomized study.
Changes in visual fields and mean deviation greater than 2 decibels at 2 years were also comparable between the two groups, Dr. Myers said, as was increase in pachymetry.
Looking at all studies of eyes implanted with iStent, Dr. Myers said, "Stent-related adverse events included stent occlusion in a small percentage of people. Luckily, this was cleared with medical and in some cases laser treatment."
- Disclosure: Dr. Myers reports consulting, lecture or speaker relationships with Alcon, Allergan, Glaukos, Haag-Streit, Inotek, IOP Inc., Merck and Pfizer.