Implantable miniature telescope shown safe over 2 years; second generation introduced

SAN DIEGO — Data on the implantable miniature telescope showed it to be safe and effective after 2 years and, while the first generation waits for approval in the United States, the second generation has been implanted in India.

R. Doyle Stulting

R. Doyle Stulting, MD, PhD, presented his 2-year data during the American Society of Cataract and Refractive Surgery annual meeting, which showed 60% of patients improve three or more lines of best-corrected distance visual acuity and a preservation rate of 93% along with a stabilization of corneal health.

"There is a significant drop [in endothelial cells] in the first year and a leveling off thereafter," Dr. Stulting said.

The data showed a "significant, obvious difference" between the improvement of patients who received only a cataract removal and those that received the IMT in conjunction with cataract removal, a question originally posed by the Food and Drug Administration.

"There was a clinically meaningful improvement for the defined population," he said. "An unmet need was met."

Dr. Stulting said the FDA is considering this and other data and he expects approval in the latter half of 2007.

Following Dr. Stulting's presentation, Isaac Lipshitz, MD, presented his recently implanted second generation of the IMT, the Lipshitz Macular Implant (LMI).

"The LMI is a promising optical solution for AMD and other macular diseases," Dr. Lipshitz told his peers.

He explained that the LMI consists of two mirrors that work together to magnify the central field of vision while maintaining the existence of peripheral vision.

A study of 7 patients concluded that the implantation procedure was simple, recovery time was comparable to refractive surgery and visual performance was equal to that of an external telescope.

Dr. Lipshitz said he expected to receive CE approval by the end of this year.