SURGICAL PEARLS

The Telescope Implant May Benefit Your Advanced AMD Patient

BY RICHARD HOFFMAN, MD, CPI & LAURIE K. BROWN, MBA, COMT, COE

As AMD progresses, central vision can deteriorate to the point where patients are challenged to see fine detail and images in their center zone. While treatment options for AMD have improved over the past 10 years with the use of intravitreal anti-VEGF medications for neovascular AMD, some patients inevitably progress to advanced AMD, in which central vision is often poor in both eyes. As a result, patients find their quality of life negatively affected when it becomes a challenge to perform tasks previously taken for granted, such as recognizing faces, reading or watching television. Driving often becomes impossible, limiting a patient’s independence. In fact, advanced AMD is associated with increased depression and stress.¹

Treating Younger AMD Patients

Since 2010, the Implantable Miniature Telescope (IMT), developed by Isaac Lipshitz, MD, has been an important treatment option for patients living with bilateral end-stage AMD as it has been shown to improve quality of life in select patient groups.² In October 2014, the U.S. Food and Drug Administration expanded the telescope prosthesis indication to include patients as young as 65 years old (it had been limited to 75 years and older) based on long-term study results demonstrating that younger patients (aged 65 to <75) have similar or better visual outcomes after implantation than their older counterparts (aged 75+) and also retained more vision than older patients over time with fewer adverse events.³ Hence, there is now an opportunity to evaluate younger patients who may be candidates for the IMT.

Figure 1. The Implantable Miniature Telescope

Finding the Right Candidate

The most obvious candidate is a patient who has been diagnosed with atrophic AMD who has progressed to stable bilateral central vision loss, is phakic in at least one eye, and whose BCVA is 20/160 to 20/800 in the better-seeing eye. The neovascular patient requires more monitoring. The best candidates have already received 2 to 5 years of anti-VEGF injections and/or laser treatments. Following 6 months of stability, the neovascular patient is a potential candidate for evaluation.

The telescope prosthesis is part of a comprehensive CentraSight treatment program that matches patients with a team of professionals, including a retina specialist, cornea surgeon, a low vision optometrist and a low vision occupational therapist who work with patients one-on-one from diagnosis through surgery and then during post-operative care and visual rehabilitation training.

Patient selection is critical to ensure a successful outcome. Beyond meeting age requirements, patients must be diagnosed with stable, bilateral, end-stage AMD (BCVA of 20/160 to 20/800) with either geographic atrophy or disciform scarring involving the fovea. Importantly, the potential candidates cannot have undergone prior cataract surgery in the eye targeted for implantation and must have adequate peripheral vision in the eye not scheduled for surgery. (The telescope implant is only implanted in one eye and limits peripheral vision. The other eye doesn’t receive an implant so peripheral vision, which is vital for orientation and balance, is maintained.) Beyond meeting other eye and health criteria, the best patient is one motivated to participate in post-operative occupational therapy to practice exercises that retrain the brain to understand the patient’s new way of seeing using the telescope implant. Many ocular comorbidities, which may increase the likelihood of complications, are criteria for exclusion. Examples are those who have had previous intraocular surgery or have a history of steroid-responsive rise in intraocular pressure, uncontrolled glaucoma, or preoperative IOP >22 mm Hg, while on maximum medication. Also, Stargardt’s macular dystrophy is currently excluded for IMT implantation.

A candidate will also undergo pre-surgery training using an external telescope to test whether the visual acuity gained from that device, evaluated using the ETDRS (Early Treatment Diabetic Retinopathy Study), equals at least a 5-letter improvement in the eye scheduled for surgery.

Moderate improvement using ETDRS criteria actually underestimates the improved vision most telescope-implanted patients report following implantation and occupational therapy. Data show that in younger patients (65 to <75 years) mean BCDVA improvement at 24 months was 3.3 lines and 2.6 lines at 60 months and in older patients (those 75+), mean BCDVA improvement was 3.1 lines at 24 months and 2.1 lines at 60 months. In both cases, this is a very meaningful and significant improvement in vision, leading to associated improvements in quality of life.³

Access and Opportunity

Following the original FDA approval in 2010,⁴ the telescope implant became a Medicare-eligible procedure,⁵ which meant it was financially within reach of most patients. Yet for many surgeons, access to this technology was limited to hospital outpatient departments due to Medicare reimbursement methodologies. While some surgical practices worked with hospitals to coordinate surgical privileges and schedule procedures, this administrative burden may have reduced excitement and uptake of a surgery that essentially uses similar instruments and supplies to the cataract and cornea procedures routinely performed in the ASC setting.

Beginning in March of this year, CMS announced that they will reimburse ASCs at levels comparable to the hospital setting.⁶ This is an enormous benefit to ophthalmic surgeons as they can now offer and perform the telescope implantation in the same place they already perform the majority of their other surgeries. The convenience of offering this relatively new and first-of-a-kind procedure in the ASC setting, combined with economically viable reimbursement, provides the mechanisms needed for broad ASC adoption of the therapy. This should significantly improve patient access.

Important Treatment Option

Advanced AMD (both geographic atrophy and neovascular) affects nearly 2 million people in the United States.⁷ Data show that the permanent loss of central vision is so distressing that the typical end-stage AMD patient would be willing to give up as much as half their remaining life in exchange for healthy vision.⁸ Therefore, while the telescope implant isn’t a cure for AMD, it’s an important treatment option to consider for patients who are eager to improve their quality of life. ■

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