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Miniature telescope improves vision at 12 months
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CHICAGO -- Ninety percent of patients with exudative age-related macular degeneration who were implanted with a telescopic IOL showed at least a two-line improvement in visual acuity at 1-year follow-up in a multicenter study, said Paul Sternberg Jr., MD.
“Despite advances in the management of exudative AMD, there remains a large population of patients with end-stage disease in both eyes,” Dr. Sternberg said during the Retina Subspecialty Day at the American Academy of Ophthalmology meeting. He said the Implantable Miniature Telescope (IMT) from VisionCare Ophthalmic Technologies may help some of these patients achieve better vision.
“The IMT is a visual prosthetic device, placed in lieu of conventional IOL, with quartz micro-optics that render the patient’s central visual field over 55° of the central retina,” Dr. Sternberg explained. “Thus, it provides a relative reduction in the size of the patient’s scotoma induced by AMD.”
The IMT uses natural eye movement to allow distance and near vision, Dr. Sternberg said.
He reported results of a prospective, open-label study of the device that included 217 patients at 28 centers. Each patient was screened by a retinal specialist, and the implantation procedure was performed by an anterior segment surgeon. The patients then worked with vision rehabilitation specialists to integrate the modified vision into their daily life.
Candidates were required to have clinical evidence of AMD and a visual acuity of between 20/80 and 20/800 with intact peripheral vision, Dr. Sternberg said. The mean preoperative baseline visual acuity was 20/316, he said.
“At 1 year, 90% of the eyes implanted with the IMT achieved the primary endpoint of two or more lines of improvement, which is considerably higher than the target level of 50%,” Dr. Sternberg said.
Dr. Sternberg said the main safety concern with the lens was a 25% loss of endothelial cell density from baseline in eyes that underwent surgery. This exceeded the target of 17% in the trial, he said.
“The device appeared to be well-tolerated, although care must be taken to limit endothelial cell loss at the time of implantation,” Dr. Sternberg said. “The majority of the cell loss appeared at time of surgery, presumably while inserting the relatively large device. Fortunately, the endothelial cell density seemed to stabilize over time.”
The data from the trial have been submitted to the Food and Drug Administration for premarket approval of the IMT. Approval is hoped for in the first half of 2006, Dr. Sternberg said.
“If approved, it will represent the first multispecialty medical model approach to improve visual function in patients with advanced AMD,” he said. “In fact, it may be an opportunity for us to refer some of those AMD patients, who were dropped on our doorstep a number of years ago, back to our anterior segment surgical colleagues.”