A 5-year study of the implantable miniature telescope for bilateral, end-stage age-related macular degeneration found positive results with a few complications.
Take Home: A 5-year study of the implantable miniature telescope for bilateral, end-stage age-related macular degeneration found positive results with a few complications.
By Vanessa Caceres; Reviewed by David Boyer, MD
Beverly Hills, CA-Although a promising implantable miniature telescope can assist patients with bilateral, end-stage age-related macular degeneration, they should be aware that the telescope is not a cure-all for vision problems and requires low-vision rehabilitation, said David Boyer, MD.
The telescope, made by VisionCare (Saratoga, Calif.), was previously approved by the FDA for patients over age 75, but that approval then expanded in October 2014 to include patients 65 to 74. The technology provides 2.7 times magnification and uses natural eye movements. It is surgically implanted in the eye.
Dr. Boyer-Retina-Vitreous Associates Medical Group, Beverly Hills, CA-shared details on the 5-year multicenter trial of the implant, which included 217 patients with a mean age of 76 years. Patients had moderate to profound bilateral central visual acuity loss that was from untreatable geographic atrophy, disciform scars, or both.
There was also a subgroup analysis with patients divided by age: one group (group 1) had 70 patients age 65 to 74, and a second group (group 2) had 127 patients age 75 or older.
Investigators examined best-correct distance visual acuity, quality of life, ocular complications related to surgery, endothelial cell density, and adverse events.
“Overall, the telescope implant has been well received and tolerated,” Dr. Boyer said. More than 63% of patients maintained two lines of improvement or more during the study period, and 47% of patients had three lines of improvement or more.
In the newer cohort of younger patients who can have the telescope, 68% maintained two lines of improvement or more, and 58% had three lines of improvement or greater.
The mean best-corrected distance visual acuity at 5 years was 2.41 lines in all patients, with 2.64 lines in the younger age group and 2.09 in the group of patients age 75 or older.
Quality-of-life scores after 1 year also increased significantly in the younger patient group.
“Looking at the quality of life scores by age stratification at the quality-of-life endpoint, both age groups had clinically meaningful gains, with the younger cohort being even more robust,” Dr. Boyer said.
The study revealed some complications with the implant. The most serious adverse event in group 1 was iritis greater than 30 days after surgery in 10% of patients and persistent corneal edema in 4.3%. In group 2, the most common adverse events were a drop in best-corrected distance visual acuity in the implanted eye or telescope removal (7.9%), corneal edema more than 30 days after surgery (7.1%), and persistent corneal edema (4.7%).
There were four corneal transplants-two each in groups 1 and 2. This was a low incidence, Dr. Boyer said. There were no retinal detachments, retinal tears, or subretinal hemorrhage for the younger population.
The study found a mean annual 3% endothelial cell density (ECD) loss, which Dr. Boyer said is consistent with previously published reports of a mean chronic cell loss of 2.8% in patients having large-incision conventional cataract surgery and intraocular lens implantation. The ECD loss was smaller in the younger patient group (35% versus 40%, respectively) at 5 years.
Dr. Boyer concluded by discussing how the telescope improves functional vision in patients with end-stage macular degeneration who are also having cataract surgery. The telescope is not a cure, and patients must participate in low-vision rehabilitation. Patients will likely also experience a decrease in peripheral vision and decrease in contrast, he added.
“I think that it’s important to realize that the patients who benefit have to undergo rigorous screening by low-vision specialists to be sure they are eligible,” Dr. Boyer said, adding that this evaluation is in addition to exams by the retinal surgeon and the anterior segment surgeon who will place the implant.
“Probably the most important factor is the low-vision simulations. If patients do that and they are happy, they will do well with the implant,” he said. Patients occasionally return for vision training to retrain their brain on how to use the implant, he added.
The results from the 5-year study were published in June in Clinical Ophthalmology.1
David Boyer, MD
This article was adapted from Dr. Boyer’s presentation at the 2015 meeting of American Society of Retina Specialists. He did not indicate any financial interest in the subject matter.