What Laser Vision Correction Means to the Military

What Laser Vision Correction Means to the Military Soldiers, Sailors,, Airmen, Marines David J. Tanzer, MD Commander, Medical Corps, US Navy Director, US Navy Refractive Surgery Program

Standard Disclaimer The presenter has no financial or proprietary interest in any material or method mentioned. The views expressed in this presentation are those of the presenter and do not necessarily reflect the official policy or position of the Department of the Navy, Department of Defense, nor the U.S. Government.

Military s s Demanding Visual Requirements Aviation High performance flight Aircraft carrier landing Unique optical devices Special Operations Diving Parachuting Night vision devices Weapons scopes Chemical / biological personal protective gear

Utility / Impact of Laser Vision Correction Improved functional vision Contact lens wear actually prohibited while deployed to Iraq, Afghanistan and Korea Lower risk for casualties

Lower risk of casualty with LASIK vs contact lens wear From Oliver Schein, MD, MPH of Johns Hopkins University's School of Medicine (Arch Ophthalmol. 2007 Jun;125(6):853-4) 4): Cumulative annual risk of infection with contact lens wear is 18/10,000 (0.18%( 0.18%). Cumulative annual risk of infection following LASIK is 1/2,000 (0.05%( 0.05%). Therefore, the risk of infection is 180 X greater with contact lenses than with LASIK over the course of a lifetime. From the ASCRS Cornea Clinical Committee: In 2007, there were 2 cornea transplants for infection following LASIK vs 55 transplants for infections related to contact lens wear.

Yearly Spectacle Requirement 12,000 8,000 4,000 Potentially treatable >100,000/yr 0 6 4 2 0 Prescription (diopters spherical equiv) -2-4 -6-8

Laser Vision Correction Research / Clinical Trials Conducted in the Military 45 studies performed to date 15 under Investigational Device Exemption (IDE) Goal is independent evaluation of LVC Specific issues addressed by military research: Quality of vision Visual recovery Environmental issues related to LVC Aviation Diving Special Operations Expanded parameters of LVC Latest technology

Results of Studies PRK in Naval Aviator Study n = 785 aviators Laser Comparative LASIK Study n = 480 patients Satisfaction analysis n = 1,200 patients Night Driving Study n = 21 patients LASIK Flap Stability Study LASIK in Naval Aviator Study n = 30 aviators

PRK in Naval Aviation Uncorrected Visual Acuity - 6 months (n = 785 aviators) 10 8 94% 98% 10 74% % of Eyes 6 4 45% 2 6% 20/10 20/12.5 20/16 20/20 20/32 20/63

PRK in Naval Aviation Change in Best-Corrected Visual Acuity - 6 months (n = 785 aviators) 5 4 3 2 1 Loss of > 2 lines Loss of 2 lines Loss of 1 line No Change Gain of 1 line Gain of 2 lines Gain of > 2 lines

PRK in Naval Aviators Summary of Complications Corneal erosion single case Incidence 0.1% Late Haze visually significant 7 eyes of 4 aviators temporarily not correctable to 20/20 quality of vision complaints Incidence 0.5% Scar single case Corneal infection following PRK Loss of best-corrected vision to 20/32 Returned to full flight status Incidence 0.1%

PRK in Naval Aviator Cumulative Flight Experience >48,000 flight hours accumulated within 6 months following PRK >19,500 landings since PRK 2,622 carrier arrested landings 10 of aviators treated to date have successfully returned to full flight status

Laser Comparative Study Uncorrected Visual Acuity - 1 Month (n = 960 eyes) 10 8 No significant differences 6 4 2 20/12.5 20/16 20/20 20/40 Alcon B&L Nidek Visx

7 6 5 4 3 2 1 Laser Comparative Study Change in Best-Corrected Visual Acuity - 6 Months No significant differences (n = 960 eyes) Alcon B&L Nidek Visx Loss >2 lines Loss 2 lines Loss 1 line No Chg Gain 1 line Gain 2 lines Gain >2 lines

Keratome Comparison Study a prospective, comparative interventional clinical trial (n = 600 eyes) 2 Surgeons 1 Excimer laser Wavefront-guided (Custom) 3 flap techniques 2 Mechanical 1 Femtosecond

10 8 6 Keratome Comparison Uncorrected Visual Acuity 1 Month Mechanical 1 Mechanical 2 Femtosecond (n = 600 eyes) 87% 74% 75% 4 2 20/10 20/12.5 20/16 20/20 20/25 20/32 20/40 All keratomes safe and effective

8 Keratome Comparison Change in Best-Corrected Visual Acuity 3 Months (n = 600 eyes) 6 4 Mechanical 1 Mechanical 2 Femtosecond 61% 57% 54% 35% 38% 34% 2 Loss >2 lines Loss 2 lines Loss 1 line No Chg Gain 1 line Gain 2 lines Gain >2 lines All keratomes safe and effective

Overall Satisfaction Following LASIK (n = 1,200 patients) 10 8 98.1% 6 4 2 Satisfied 1.9% Dissatisfied

Change in Night Driving Performance with Glare After LASIK 40 Preop to postop change in feet 30 20 10 0-10 -20-30 Detection Identification Improved after surgery

Significant Change of 5 Night Driving Performance 46% 41% 25% 28% 18% Loss Gain 3% 3% 3% Det ID Det w/glare ID w/glare Preop-postop postop Δ greater / less than - 44 feet

Significant Change of Night Driving 10 75% Loss No Change Gain 5 46% 41% 25% 28% 18% 3% 3% 3% Det ID Det w/glare ID w/glare Preop-postop postop Δ greater / less than - 44 feet

Is the flap stable?

Flap Stability Study 100 Force Gauge (lbs) 80 60 40 20 Halo 400 knot ejection Flap Displacement 0 50 150 250 350 450 550 650 Chamber Pressure (lbs/in 2 ) Laurent JM, et al. Stability of the LASIK corneal flap in a rabbit model. Journal of Cataract and Refractive Surgery 2006, 32(6):1046-51

LASIK in Naval Aviators Uncorrected Visual Acuity 2 weeks (n = 30 aviators) 10 8 94% 10 6 57% 4 2 22% 20/10 20/12 20/16 20/20

5 LASIK in Naval Aviators Change in Best-Corrected Visual Acuity (1 month) (n = 30 aviators) 4 38% 43% 3 2 18% 1 3% Loss >2 lines Loss 2 lines Loss 1 line No Chg Gain 1 line Gain 2 lines Gain >2 lines No eye is worse than 20/20 UNCORRECTED

LASIK in Naval Aviators 1 month questionnaire Do you feel LASIK has helped or hindered your effectiveness as a Naval Aviator 10 8 6 4 2 95% 5% helpful same hindered 10 8 10 Would you recommend LASIK treatment to Naval Aviation 6 4 2 definitely yes definitely no

DoD Refractive Surgery Centers Warfighter Refractive Surgery Program 20 total centers: 8 Army, 7 Navy, 5 Air Force Landstuhl ARMC Tripler AMC

DoD Laser Vision Correction Cumulative Total In Thousands 240 220 200 180 160 140 120 100 80 60 40 20 0 Air Force Navy Army FY00 FY01 FY02 FY03 FY04 FY05 FY06 FY07

Demographics of Laser Vision Correction Patients in the Military Age Average age of military LVC patient: 34 Average age of civilian LVC patient: 37 Age range: 18-60 Gender 82% male, 18% female 50:50 gender ratio in civilian LVC Refractive Error Range: +6 to -13 diopters

Laser Vision Correction in the Military Number of treatment >224,000 procedures performed in the military to date Impact Air Force: Army: Navy: >51,000 procedures >100,000 procedures >73,000 procedures Laser Vision Correction is approved for ALL aspects of military service,, including aviation, special operations and support personnel LVC is approved for NASA astronauts Surgery is not without risk

Relative Risk of Laser Vision Correction in the Military Only 1 DoD medical disability retirement related to LVC to date Medical board due to quality of vision complaints despite 20/20 uncorrected vision Rate of 1:112,500, or 0.009%

Summary of US Military Warfighter Laser Vision Correction Program LVC has been overwhelmingly successful in the military, in ALL job types LVC has shown tremendous operational benefits Approved for military aviators, divers, special operations personnel and NASA astronauts LVC has been proven to have extremely low risk Likelihood of disability is 0.009% Satisfaction is incredibly high in service members receiving LVC Enhances job performance 95% improvement in effectiveness as Naval aviator 10 of treated Naval aviators would recommend procedure to fellow aviators

Summary Perspective I have had the privilege of treating and then flying with the first F/A-18 Hornet pilot to have refractive surgery and who then landed on an aircraft carrier. As we flew toward the ship that night,, he relayed to me that he had never seen the carrier and the landing lights better.. I took great pride in that fact, not only because I was in the jet at the time, but because I had provided a service that permanently improved his ability to perform this visually demanding task. Since this inaugural case, we have treated more than 1,000 aviators,, several of whom I have flown with. If I did not personally believe that LVC was in their best interest, I would not be treating anyone on active duty with LVC or advocating that it be done in the civilian community.