Fort Belvoir Community Hospital in Virginia is the first U.S. Department of Defense (DoD) medical facility to perform the revolutionary laser vision correction procedure, ReLEx® SMILE from ZEISS. The Naval Medical Center San Diego is scheduled to perform first procedures in the coming weeks. Following the recent U.S. FDA approval* of ReLEx SMILE for the treatment of myopia, or nearsightedness, all three branches of the DoD, the Army, the Navy and the Air Force, have plans to offer SMILE for eligible service members. This will include an extensive evaluation of SMILE to correct myopia and astigmatism under some of the most visually demanding conditions. The DoD has an expansive refractive surgery program with over 20 dedicated centers around the world which performed over 40,000 refractive surgery procedures last year.
“Dependence on eyeglasses or contact lenses can be a challenge for many people in their daily lives. The conditions that nearsighted patients face in the performance of military duties can be life-threatening if their vision is compromised,” says Jim Mazzo, Global President Ophthalmic Devices at Carl Zeiss Meditec. “The expectations of surgeons and patients who serve in the military are exceptionally high. These first cases by Dr. Rivers represent the first step towards adoption of SMILE across all three branches and will enable their surgeons to offer the newest, most advanced refractive laser technology to service members who face some of the most demanding situations requiring perfect vision.”
“We are excited that U.S. service members can now be treated with this innovative technology and that we have a new refractive surgery option to help increase the safety and the performance of the service men and women who are called to go into harm’s way,” said Army Col. Bruce Rivers, M.D., Director of the Warfighter Refractive Eye Surgery Program and Research Center at Fort Belvoir Hospital. “The visual requirements for military personnel are demanding. Myopic correction with eyeglasses or contact lenses restricts some of the best and brightest from various roles in the military and causes difficulties in deployed environments. SMILE is a breakthrough surgical vision correction option which can be life-changing for many and life-saving for first responders and for those in dynamic roles.”
ReLEx SMILE, a high-precision procedure which was recently approved by the U.S. FDA, is an innovative minimally-invasive approach to myopia correction that is only available on the VisuMax® femtosecond laser from ZEISS. In the SMILE procedure, surgeons correct patients’ myopia using the VisuMax femtosecond laser to create a precise disc-shaped lenticule within the cornea, which is then removed by the surgeon through a small incision, also created by the laser.
“SMILE has shown excellent reproducibility and predictability in the U.S. FDA clinical study, even with severe corrections. SMILE can help improve the readiness for our active duty members as it can eliminate reliance on vision correction methods such as eyeglasses or contacts,” continues Dr. Rivers. “Plus SMILE is a laser vision correction option that may result in greater strength and stability for the eye compared to alternatives. Patients typically experience minimal discomfort and can rapidly return to daily activities.”
“For over 20 years, the DoD has been a pioneer in refractive surgery, independently evaluating and then offering the best refractive technology to the people that we entrust to defend our country,” says Steven C. Schallhorn, M.D., founder of the U.S. Department of Defense refractive surgery program and Chief Medical Officer for Global Ophthalmic Systems at Carl Zeiss Meditec. “This first SMILE procedure is another important milestone which I believe will usher in a new direction for the DoD refractive surgery program.”
Over 700,000 SMILE procedures have been performed internationally since its introduction in 2011 with over 1000 surgeons regularly performing the procedure. Now with the U.S. FDA approval, SMILE, the latest refractive technology from ZEISS, can be used by doctors at the U.S. Department of Defense to continue providing the most advanced medical care to U.S. service members.
ZEISS is also conducting an IDE trial in the U.S. on astigmatic myopia to further broaden the spectrum of SMILE for more patients.
*U.S. FDA Approved Indications for Use:
For use in the reduction or elimination of myopia -1.00 D to -8.00D, with ≤ -0.50D cylinder and MRSE -8.25D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year.