New data on the long-term safety and efficacy of VisionCare's implantable miniature telescope supports use of the FDA-approved device in younger patients with end-stage age-related macular degeneration.

Marie Thibault

July 1, 2015

16 Min Read
Long-Term Data Bolsters Use of Implantable Miniature Telescope

Marie Thibault

The Implantable Miniature Telescope implant from VisionCare Ophthalmic Technologies, Inc. is used in patients with end-stage age-related macular degeneration.

The only FDA-approved surgical device for patients suffering from end-stage age-related macular degeneration (AMD) was the recipient of more good news this week. Patients who were implanted with the Implantable Miniature Telescope (IMT), from VisionCare Ophthalmic Technologies, Inc., had visual acuity gains at both two and five years following implant. 

The younger cohort, made up of patients age 65 to 74 years old, and the older group, 75 years of age and older, both had good visual acuity results with the IMT, although the younger group had maintained more of their vision improvements at the five year mark and had fewer complications. These findings back up the FDA indication expansion in October 2014 to grant younger patients, age 65 to 74, access to the technology. Previously only patients 75 years of age or older were included in the IMT's indications for use. The results were published in Clinical Ophthalmology as "Long-term (60-month) results for the implantable miniature telescope: efficacy and safety outcomes stratified by age in patients with end-stage age-related macular degeneration."

According to a press release from Saratoga, CA-based VisionCare Ophthalmic Technologies, Inc., the IMT is intended for use in patients with "stable severe to profound vision impairment (best-corrected distance visual acuity 20/160 to 20/800) caused by bilateral central scotomas (blind areas) associated with end-stage AMD." Patients undergo an outpatient surgical procedure to receive the implant in one eye. This gives the patient better central vision in that eye and the unaltered eye is relied upon for peripheral vision. The IMT procedure is also reimbursed by Medicare.

The IMT was initially studied in a two-year long pivotal study with 217 end-stage AMD patients enrolled. The study was continued, with 63 of the original patients reaching five year follow up (31 patients in the younger group, 32 patients in the older group). In the entire group, the study investigators found a mean visual acuity gain of 3.2 lines at two years and a mean gain of 2.4 lines at five years, meaning patients held on to much of their improvements. When analyzing the younger (65 to 74 years old) patients versus the older (75+ years old) patients, the researchers found a higher percentage of younger patients—68%—maintained a 2-line visual acuity gain at five years while 59% of older patients did the same. The younger patients had a mean gain of 2.7 lines at five years; the older patients had a mean gain of 2.1 lines at that point.

Lead study author David Boyer, MD, vitreoretinal specialist at Retina-Vitreous Associates Medical Group in Beverly Hills, CA, said in the press release, "The fact that these 65 to 74 year-old patients, on average, retained nearly three lines of improvement five years after telescope implantation is tremendous."

VisionCare CEO Wolfgang Tolle wrote in an e-mail to MD+DI, "Given these strong results, physicians should feel confident recommending their patients with bilateral end-stage AMD to the CentraSight program for evaluation so that also younger patients can see better and sooner." CentraSight is the company's treatment program.

The adverse event rate was higher in older patients. The rate of visual acuity loss of more than 2 lines was 8% in the older group and 6% in the younger group. Corneal transplant was required in 3% of the older patients and 2% of the younger patients.

One of the study authors, Carl Regillo, MD, director of Retina Services at Wills Eye Hospital, said in the press release, "With this data and the corresponding age-related expanded indication by the FDA, retina specialists should consider recommending their end-stage AMD patients for surgery so that they may potentially benefit from better vision and improved quality of life sooner."

The study also included patients younger than 65 years of age. These youngest patients had a mean gain of 2.58 lines at five years and experienced fewer adverse events. In the published study, the authors note that IMT use is at least as safe for younger patients as it is for patients 75 years old or older: "Telescope implantation does not expose patients aged 65 to <75 years (or even patients <65 years of age) to a higher undue safety risk as compared with patients >75 years of age."

This new data set may bring more attention to the IMT technology. In an e-mail to MD+DI, Boyer wrote, "Unfortunately, most patients are not aware of this relatively new technology but awareness is growing. Most of the patients who come asking for the lens have already had cataract surgery and are not seeing well. Many cataract surgeons are unfamiliar with the technology and don't end up screening the patients to see if they would benefit. So, more so, it is important that we raise awareness about this treatment option within the ophthalmic community, so that ophthalmologists can feel confident recommending patients for evaluation."

Tolle wrote, "We intend to use this data to educate the ophthalmic community about the telescope implant as a potential treatment option for advanced AMD patients and ask ophthalmologists to recommend patients for evaluation."

Going forward, VisionCare intends to explore more applications for the IMT technology, including use in patients who have previously had an intraocular lens implanted. "I think we will want to evaluate the telescope implant for the pseudophakic patient. Data generally shows that cataract surgery in an end-stage AMD patient isn’t particularly impactful. However, these end-stage AMD patients with prior cataract surgery may well benefit from the IMT implant," Tolle wrote. 

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Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie

[Image courtesy of VISIONCARE OPHTHALMIC TECHNOLOGIES, INC.]

About the Author(s)

Marie Thibault

Marie Thibault is the managing editor for Medical Device and Diagnostic Industry and Qmed. Reach her at [email protected] and on Twitter @MedTechMarie.

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