This article is more than 5 years old. Information may no longer be current.
Utah practice performs first commercial implantations of Kamra corneal inlay in US
The practice has a long waiting list of patients and expects to perform several hundred implantations by the end of 2015.
Click Here to Manage Email Alerts
An ophthalmology practice in Utah was the first in the U.S. to commercially implant the Kamra inlay in a group of presbyopic patients.
Phillip C. Hoopes Jr., MD, and colleagues at Hoopes Vision, Draper, Utah, implanted the first 15 Kamra inlays (AcuFocus) on May 19, 1 month after the implant was approved by the FDA.
“We were able to implant 15 on that initial day. Since that time, we’ve been able to put in about 20 more, so I think we’re up to a total number now of 35 inlays implanted since FDA approval,” Hoopes told Ocular Surgery News.
Hoopes said he and colleagues hope to implant several hundred Kamra inlays by the end of the year.
“When we were enrolling in the FDA study, we had 750 telephone calls from patients who were interested in being enrolled in the study,” Hoopes said. “We have a waiting list now of several hundred patients who have been waiting for this technology, just as the surgeons have.”
During the FDA clinical trial for the Kamra inlay, Hoopes and colleagues implanted the inlay in about 60 patients.
“We were able to monitor and follow those patients, some for 3 years and some for extended study out to about 5 years,” Hoopes said.
Indications and guidelines
The Kamra is approved for patients between the ages of 45 and 60 years who have not had cataract surgery, require between +0.5 D and –0.75 D of correction, and have astigmatism no greater than 0.75 D.
“Even though that’s in the labeling, when you take a look at the patients in the FDA study, it became very clear that those patients who were slightly hyperopic didn’t have as good of a result as those who were slightly myopic,” Hoopes said. “The target population for Kamra patients, going forward, will be those patients who are presbyopic and slightly myopic, probably –0.5 D to –0.75 D in their refraction. Basically, we’re going to look for the mild myopic presbyopic patients as the patients who will do the very best with this inlay.”
The inlay is not indicated for patients who have had cataract surgery. However, Hoopes noted that two patients who participated in the clinical trial later underwent cataract surgery.
“They were able to undergo routine cataract surgery. I was able to perform the surgery without any difficulty in the eye that had the Kamra. And they were able to continue with their Kamra after cataract surgery and have done very well with the inlay following routine cataract surgery,” Hoopes said.
Hoopes said that, for now, surgeons who implant the Kamra should follow FDA guidelines and indications.
“Based on patient selection guidelines from the FDA, it’s basically a plano presbyopic patient who has never had eye surgery. That’s what it’s indicated for,” Hoopes said. “Now, it will be up to the surgeon’s discretion in time to broaden that out based on experience. There will be surgeons who use the Kamra in post-LASIK patients. There will be surgeons who use the Kamra in post-IOL patients. However, that wasn’t studied by the FDA. We’re being very careful early on in this first year just to promote it under the FDA guidelines.”
Early complications
During the clinical trial, Kamra inlays were implanted under a LASIK flap, resulting in a high rate of dry eye, Hoopes said.
“Some of the adverse events noted during the FDA trial were dry eye,” he said.
Another common complication after Kamra implantation is hyperopic shift, Hoopes said.
“This was responsive to steroid tapers, so now, after the U.S. launch, the steroid taper regimen has been updated in patients to be on postoperative steroid drops for about 3 months following their Kamra surgery,” he said.
Currently, the inlays are implanted in corneal pockets created with a femtosecond laser, Hoopes said.
“That’s the recommended guideline. Even the spot size separation of the femtosecond laser has been indicated to be a 6 µm by 6 µm spot size separation,” he said. “Right now, the only recommended technique is to use pocket software, whether it be the IntraLase iFS (Abbott Medical Optics), the WaveLight FS200 (Alcon) or the Ziemer femtosecond laser. They now all have capability for pocket software creation.” – by Matt Hasson
- For more information:
- Phillip C. Hoopes Jr., MD, can be reached at Hoopes Vision, 11820 State St., Draper, UT 84020; email: pchj@hoopesvision.com.
Disclosure: Hoopes is a consultant for Abbott Medical Optics and owns shares in AcuFocus.
Perspective
Back to Top
Karolinne Rocha, MD, PhD
Recently approved by the FDA, the Kamra corneal inlay is a 3.8 mm ring, 5 µm thick, with a 1.6 mm central opening, and 8,400 laser micro-perforations that allow 6.7% of light transmission. Its small aperture design extends the patients depth of focus while maintaining stereoscopic vision. The best candidates for corneal inlays include baby boomers and early presbyopes (generation X), with refraction ranging between plano and 0.75 D, 0.75 D of astigmatism or less in the non-dominant eye. Femtosecond laser pockets of 180 µm or deeper with tight spot and line separation and slow steroid taper are recommended. Assessing patients lifestyles and expectations, and ocular surface optimization are the key to success.
Click Here to Manage Email Alerts