FDA OKs Implantable Telescope to Aid Vision
Implantable Miniature Telescope Improves Sight for Patients With Macular Degeneration
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Potential Side Effects
Patients with end-stage macular degeneration also may have visually significant cataracts, the FDA says. Patients must agree to participate in a postoperative visual training program to be eligible for the device.
The FDA says that in a 219-patient clinical study of the IMT, 75% improved their level of vision from severe or profound impairment to moderate impairment.
Although smaller than the size of a pea, the IMT is large enough to pose a threat to the cornea of the eye, leading to extensive loss of cells essential for maintaining the clarity of the cornea.
In the study, 10 eyes had unresolved corneal edema, or swelling, caused by trapped fluid. Five such cases resulted in corneal transplants.
The FDA says the five-year risk for unresolved corneal edema, corneal decompensation, and corneal transplant are 9.2%, 6.8%, and 4.1%, respectively.
As part of the program, patients and their doctors must agree to discuss the risks associated with implantation.
Also as a condition of FDA approval, VisionCare must conduct two post-approval studies. In one, it is required to continue follow-up of patients from its long-term group for two years. Another study of 770 newly enrolled people will include an evaluation of the endothelial cell density and related adverse events for five years after the device is implanted.