Linda Roach

June 05, 2013

SAN FRANCISCO, California — The first 4 patients with age-related macular degeneration to receive an implantable miniature telescope gained 0.58 logMAR of best-corrected distance visual acuity in the implanted eye, without operative or near-term post-operative complications, report clinicians at the University of South Carolina.

Prior to surgery, the eyes had a mean best-corrected distance visual acuity of 1.70 logMAR (20/1000; range 1.29 - 2.05 logMAR), according to presenter David Tremblay, MD. Two months later, this improved to a mean of 1.12 logMAR (20/250; P = .028), he reported.

Dr. Tremblay presented the results here at the American Society of Cataract and Refractive Surgery 2013 Symposium.

The miniature telescope by VisionCare Ophthalmic Technologies, in Saratoga, California, is approved for use in patients aged 75 years or older, who have moderate-to-severe central visual impairment from end-stage macular degeneration.

Success with the implant is defined by improvement in everyday visual functioning as opposed to absolute visual acuity, which remains low, coauthor Charlene Grice, MD, emphasized during an interview with Medscape Medical News.

"One of our patients can crochet again, and she brought us in some crocheted potholders. Another had been unable to cook. She brought us some fudge. The third is a bridge player, and she can play bridge again," said Dr. Grice, from the Medical University of South Carolina, in Charleston.

Follow-up was about 10 months for the first patient enrolled and 3 months for the most recent patient, who has been their only male implant recipient so far, Dr. Tremblay reported.

At regular postop examinations, the researchers monitored best-corrected visual acuity at a distance and near and the health of endothelial cells. They also looked at the incidence of complications and adverse events and so far there have been none.

Large Incision

Implanted after phacoemulsification in the capsular bag of the patient's worse-seeing eye, the approach pairs a minus and a plus lens, housed together in a single device, to project wide-field magnified images (up to 3X) onto the retina, Dr. Tremblay explained.

The images span 55 degrees compared with 5 degrees of focus by the crystalline lens. This minimizes the patient's central scotoma while also giving a 20- to 24-degree field of view, he noted, citing research by Singer and colleagues ( Clin Ophthal. 2012;6:33-39).

Although the US Food and Drug Administration approved the implants in July 2010, surgeries could not start until reimbursement issues were resolved, one Medicare region at a time, beginning last year. The South Carolina team performed its first implant surgery in July 2012.

Dr. Grice, the cornea and refractive surgeon in these cases, said she was pleased that the difficult surgeries went smoothly. "It's a large incision. Most cataract surgeons think a 2.7 mm incision is large these days. The incision for this is 12 mm. But none of the cases needed to be aborted," she explained.

VisionCare's screening, surgical, and postop rehabilitation protocols require a detailed patient selection process by a cornea surgeon, a vitreoretinal specialist, an occupational therapist, and a low-vision therapist before the device can be implanted, she noted.

The rehabilitation process is a commitment that the patient has to buy into on the front end.

"Once you do that implant you can't go back and treat the age-related macular degeneration so the retinal surgeon has to certify that there is no benefit to treatment anymore," Dr. Grice said.

The other 2 team members evaluate the patient's suitability for prolonged postop rehabilitation, she added. "The rehabilitation process is a commitment that the patient has to buy into on the front end. They have to continue to learn to use the implantable miniature telescope for months after the procedure."

Susan Primo, OD, MPH, director of low vision services and ophthalmology professor at the Emory Eye Center, in Atlanta, Georgia, said she agrees. "It takes a while to find the most appropriate individual."

Only about 1 in 5 of the people screened for surgery at Emory has qualified, she said. The Emory team did its first surgery last fall, and has done 3 so far, with results similar to those reported by the South Carolina clinicians.

The visual rehab process after surgery is "very goal-oriented and specific" to the individual patient's visual needs, Dr. Primo explained. "The whole point of this is to regain some independence, and to feel like the quality of life is improved based on this acuity increase."

This study received no external funding. Dr. Tremblay and Dr. Grice have disclosed no relevant financial relationships. Dr. Primo does implantable miniature telescope training of optometrists, as a consultant for VisionCare Ophthalmics.

American Society of Cataract and Refractive Surgery (ASCRS) 2013 Symposium: Paper session 1-L. Presented April 20, 2013.


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