LaserVision

The KAMRA™ Inlay Receives FDA Approval

The KAMRA™ Inlay Receives FDA Approval

kamra-fda-approved

This month, the United States Food and Drug Administration has approved the groundbreaking treatment by AcuFocus, the KAMRA inlay. This represents the first major advancement in the surgical correction of presbyopia in well over a decade.

The KAMRA inlay improves near vision by extending depth of focus in presbyopic patients who have emmetropic refractions (+0.50 D to #0.75 D). Presbyopia is the age related loss of near vision that affects virtually everyone over the age of 50. Currently, many people rely on reading glasses to see objects up close.

“After a decade of research, development and clinical investigation, we are delighted to bring this innovative technology to surgeons and patients in the U.S.” said Jim Mazzo, Chairman and CEO of AcuFocus, Inc.

The KAMRA inlay approval was based on the results of 508 patients treated at 24 investigational sites worldwide. Patients in the clinical study experienced an average improvement in uncorrected near visual acuity of 3.0 lines between their pre-op exam and the 12 month follow-up visit. This improvement was maintained over the 5 year duration of the study. Meanwhile, pre-operative uncorrected distance visual acuity in the inlay-implanted eye was maintained across all follow-up exams, unlike other presbyopia correcting procedures where distance vision is compromised in order to improve near vision.

The KAMRA inlay is an ultra-thin opaque ring that is implanted monocularly into the patient’s non-dominant eye. The device utilizes the principle of small aperture optics, or pinhole effect, to extend depth-of-focus for patients. As a result of this novel design, central focused light is allowed to reach the retina uninterrupted resulting in functional vision from near to far without reading glasses.

Read more about the KAMRA Inlay available at LaserVision’s Guildford hospital.

About AcuFocus
AcuFocus Inc. is a privately held ophthalmic medical device company that develops and markets breakthrough technologies for the improvement of near vision. For more information, visit www.AcuFocus.com.

fred chow
fred chow
2023-11-24
Mr Tappin, top consultant and trusted surgeon for your cataract!
Jason Green
Jason Green
2023-09-06
Professional competent advice and absolutely no pressure to make a decision. I could not have predicted how much this procedure has changed my life in such a positive way. Thank you team.
Lelita Baldock
Lelita Baldock
2023-07-25
Dr Tappin and the team at LaserVision were amazing. I underwent Lasik corrective surgery and the process could not have been smoother. I was guided through the process with care and professionalism throughout. My results have been outstanding. I could not have asked for more from the team at LaserVision and I am truly grateful for my new vision.
Robert & Gia Anderson
Robert & Gia Anderson
2023-06-08
Utterly professional and caring from start to finish. I was quite nervous about having laser but am so pleased with the results. There has always been someone to advise and support every step of the way and patient care and well being really is the priority here. Thank you for looking after me and my eyes so well.
NewestToad
NewestToad
2023-04-24
Really excellent level of care from Mr. Rakesh - great communication, excellent standard of care, no complaints whatsoever, top notch service!
Christina Cook
Christina Cook
2023-04-17
Mr Tappin and his team are very professional and efficient. The whole experience from beginning to end was done with ease. I highly recommend.
Amanda Thorsen
Amanda Thorsen
2023-03-10
Dr Jayaswal has been amazing and changed my life. He made me feel so comfortable and relaxed in his care at the first meet, to remembering me with a personalised greeting, calmly explaining the procedure and reassuring me all the way through the surgery. I couldn’t recommend him enough for Lasik eye surgery - I now have perfect vision, a real dream come true! Thank you so much!
Nikki Blake
Nikki Blake
2023-02-02
Fantastic process from beginning to end - professional yet incredibly personable. The professional team, especially Mr Tappin, made me feel at ease throughout and the surgery was a great success.
April Dansie
April Dansie
2022-12-22
I had lens replacement surgery. After being both short sighted and long sighted for decades I can now see near and far without glasses or contact lens. It really is amazing. The care was great and so far the recovery has been easy.
George Judge
George Judge
2022-11-03
Amazing service from start to finish, I had LASIK surgery in August this year after years of consideration I finally took the plunge and went for the surgery with Mr Tappin. Mr Mike Tappin and his team were brilliant from the consultation right through to the surgery and aftercare. Mr Tappin and his team were very reassuring throughout the surgery and put me at ease every step of the way. If you are thinking about having laser eye treatment or at the start of your journey with it, I would highly recommend seeing Mr Tappin and his team!
View via Google
Events