Telescope offers potential for improved vision in patients with end-stage AMD

Am J Ophthalmol. 2008;146(5):664-673.

An implantable telescope prosthetic device was safe and improved visual acuity in patients with end-stage age-related macular degeneration.

In a prospective, open-label, multicenter trial, 103 of 173 eyes (59.5%) with an Implantable Miniature Telescope prosthesis (VisionCare Ophthalmic Technologies) had an improvement in best corrected visual acuity of three lines or more. Only 18 of 174 fellow control eyes (10.3%) had similar improvement. Improvements in BCVA measured at 1 year were maintained at 2 years.

Loss of three lines of BCVA occurred in one eye implanted with the telescope device and in 13 fellow eyes. There were also eight devices removed: two cases of device failure, two cases of corneal edema and four at the patient's request. The most common complications associated with the implant were inflammatory or pigment deposits on the device, guttae, posterior synechiae, iris transillumination defects lasting more than 21 days and iritis lasting longer than 30 days.

"None of the most frequent complications (eg, inflammatory deposits) proved to be a significant safety concern," the study authors said.

Rates of endothelial cell loss were higher than typically seen with small-incision anterior segment eye surgery but were consistent with anterior segment procedures employing similar larger incision sizes.

The device has received CE Mark approval in Europe and is currently under regulatory review by the U.S. Food and Drug Administration, VisionCare said in a statement announcing the study results.