Did Army Surgeon, Scott Barnes, Give Misleading Testimony?
From the article: "While Dr. Barnes spoke about "refractive surgery", his testimony in the context of a special hearing on LASIK implied that his arguments were in support of the LASIK procedure. Indeed, the Summary Minutes of the FDA hearing stated that, "Dr. Barnes of the Warfighter Refractive Eye Surgery Program emphasized the importance of LASIK to the military." The FDA hearing testimony of Lt. Col. Scott Barnes is inconsistent with his recent publications." Read article
9/8/2010 update: Lt. Col. Scott Barnes states that 50% of soldiers have worse vision after LASIK than they did with their contacts. Source
Study finds LASIK is not safe for military personnel - April 2012
Chin J Traumatol. 2012 Apr 1;15(2):77-80.
Laser in situ keratomileusis surgery is not safe for military personnel.
Xiao JH, Zhang MN, Jiang CH, Zhang Y, Qiu HY.
Department of Ophthalmology, Chinese PLA General Hospital, Beijing 100853, China.
Abstract
Objective: To investigate the relationship between eye injury and laser in-situ keratomileusis (LASIK) surgery in military personnel.
Methods: This retrospective study collected the data from 27 evacuation hospitals of Chinese army. All medical records of eye injuries in military personnel admitted to the 27 hospitals between January 2006 and December 2010 were reviewed. Patients'detailed information was analyzed, including the injury time, place, type, cause, as well as examination, treatment and outcome.
Results: There were 72 eye-injured patients who had been treated by LASIK before. The incidence was rising year by year. Among them, 69 patients were diagnosed with mechanical ocular injury and 3 with non-mechanical ocular injury; 29 patients had traumatic flap-related complications and 21 patients need surgery. There was statistical difference when compared with those having no refractive surgery history. Visual acuity recovered well at discharge.
Conclusion: There is a high risk of potential traumatic flap problems after LASIK and it is not recommended in army service.
Opinion Editorial from the webmaster of LasikComplications.com - 9/22/2010
Military LASIK surgeons are quick to assert that complications of LASIK in the military are rare. We don't buy it. We believe that servicemen are less likely than the civilian population to report problems or complain. This may be due to concerns of duty reassignment or fear of being perceived as weak.
According to Dr. Michael Allen, director of research at the University of Colorado Denver Depression Center, "In any group of men where toughness is valued, talking about anything that may be viewed as weakness goes against the grain." Source
Read Naval aviator Internet forum regarding starbursts after laser eye surgery, and Naval aviators' admissions to hiding laser eye surgery induced visual impairment. Read here
Lt. Cmdr. John B. Cason, M.D. on Post-LASIK corneal neuralgia - Feb. 2012 EyeWorld
From the article: Corneal neuralgia is a newly described disease process refractive surgeons wish was mythological. Lt. Cmdr. John B. Cason, M.D., cornea, external disease, and refractive surgery, Naval Medical Center, San Diego, gave an overview of the symptoms, which many patients find excruciating. "The hallmark of this is how uncomfortable these patients are," he said. "But when you examine them, you don't see anything causing it. These patients are extremely difficult to treat; they keep coming back to your clinic. All the therapies you give them fail, and because of this, many of us think they're making it up." The pain these patients are feeling, however, is very real. Some patients are so uncomfortable and so despondent over failed treatments that they become suicidal. As one patient Dr. Cason had in fellowship said, "I want my eyes taken out or I want to die."
Military PRK patient files injury report with the FDA, "I manned up the best I knew how"
I had PRK surgery [redacted] 2011 at the [redacted]. I was told I would be back to work 6 days later with close to corrected vision. I came back for my four day check up, they took the contacts out of my eyes. I was told it would feel a little gritty for a couple of days. I didn't make it fifteen minutes down the road and I felt like I had razor blades underneath my eyelids. Being in the military, I manned up the best I knew how, put way more than prescribed numbing drops and took multiple narcotic pain pills. None of this worked. I got a hold of my surgeon and told him I would try and hold out until the next day. It was the worst pain I have ever experienced in my life. The next day I went down and they said my eyes had "sluthed. " they put the contacts back and for approx two more weeks, waiting for an 8mm abrasion on both of my eyes to heal up - the civilian ophthalmologist noticed these abrasions, right before my surgeon came and looked at my eyes, and overlooked them! the abrasions never healed up, so they patched my eyes for a week and a half a piece and the abrasions finally healed up, leaving behind a lot of scar tissue, which I am still dealing with now. I've been on a long dose of steroids and I am still tapering off of them, and yet the scarring still has not gotten any better. I volunteered for this surgery to make my life better, easier, and more mission ready for my certain career field in the [redacted]. It was placed to my understanding that this was a fairly quick and short term healing procedure. But I am supposedly one of the thousands of select people that this happens to. I was told that after the six month period from my surgery, if this scarring was not healed that I could opt for the surgery again or just deal with it.
FDAweb.com editor criticizes FDA's collaboration with Department of Defense in LASIK investigation - 4/19/2010
James Dickinson, editor of FDAweb.com, wrote a letter to patient advocate, Dean Kantis, criticizing FDA's regulation of LASIK devices and the agency's inappropriate collaboration with the American Society of Cataract and Refractive Surgery (ASCRS) and Department of Defense (Navy) in the current LASIK study.
Naval aviators hide the truth about starbursts after laser eye surgery. Read here
Permanent grounding of a USAF pilot following photorefractive keratectomy.
Aviat Space Environ Med. 2010 Nov;81(11):1041-4.
Davis RE, Ivan DJ, Rubin RM, Gooch JM, Tredici TJ, Reilly CD.
Aeromedical Consultation Service, USAF School of Aerospace Medicine, 2507 Kennedy Circle, Brooks City-Base, TX 78235, USA.
Abstract
INTRODUCTION: Photorefractive keratectomy (PRK) has been extensively studied in the literature and its potential application in aircrew has not gone unnoticed. Complication rates following corneal refractive surgery (CRS), including PRK and laser in-situ keratomileusis (LASIK), remain low, with most patients achieving improved uncorrected visual acuity and reduced spectacle dependence. Overall, predictability, low complication rates, high rate of success, stability, and safety have all been cited as instrumental in the adoption of PRK in aviators. Consequently, the U.S. Air Force (USAF) approved PRK for aviators in August 2000. However, quality of vision outcomes following CRS remain a concern given the unique visual performance requirements in military aircrew, especially in austere operational environments.
CASE REPORT: This paper will present a recent case of steroid-induced ocular hypertension that is believed to have precipitated non-arteritic anterior ischemic optic neuropathy (NA-AION) associated with reduced visual performance following PRK that resulted in the first permanent grounding of a USAF pilot following CRS.
DISCUSSION: CRS has radically widened the aircrew applicant pool and has decreased spectacle dependence in war-fighters. Despite the low-risk profile of modern CRS, this case demonstrates the potential for poor outcomes from such elective surgery. Understanding these rare, but potentially devastating complications and the unique aeromedical risk factors in aircrew is paramount when considering elective vision-enhancing surgery.
Lasik's blurry vision - Salon.com 1/25/2010
From the article: Erik J. Rupard, a doctor and clinical researcher with the U.S. Army, is among those who think such scrutiny is necessary... "I saw lots of dry-eye complications in soldiers in Iraq who had undergone the procedure ostensibly because contacts are too unsafe in that dusty environment, and yet the Department of Defense has done no controlled studies to look at the cost -- human and otherwise -- of these post-refractive issues. I am a clinical researcher, and I know that Lasik, a cosmetic procedure, has never been subjected to the pre- or post-marketing scrutiny that we put even lifesaving drugs through."
Traumatic Flap Striae 6 Years After LASIK: Case Report and Literature Review.
Excerpt: Military, law enforcement, and contact sport personnel should be counseled to consider surface ablation or wear eye protection. Regarding the latter, however, we recommend that safety counseling be broadened to all patients in light of the mundane mechanisms of injury seen and the random nature of trauma. Given the growing evidence for chronic flap vulnerability and the relative youth of many LASIK recipients, long-term risks are increasingly relevant.
Source: Ursea R, Feng MT. J Refract Surg. 2009 Dec 28:1-7. doi: 10.3928/1081597X-20091209-02.
Late traumatic femtosecond LASIK flap loss
A 22-year-old male Marine had femtosecond-facilitated LASIK performed by another surgeon in our facility. The immediate postoperative period was uneventful... Eight weeks after surgery, the patient called the clinic, stating he had been struck in the right eye by a friend’s finger. He described experiencing a feeling of something on his cheek, which he had discarded. He was directed to come to the clinic immediately with a driver. He arrived within 2 hours of the injury; on examination, it was discovered that he had complete flap loss.
Source: J Cataract Refract Surg. 2009 Jun;35(6):1134-7. Visual acuity recovery after late traumatic femtosecond laser in situ keratomileusis flap loss. Thomas KE, Tanzer DJ. Naval Hospital Camp Pendleton, Camp Pendleton, and the Naval Medical Center San Diego, San Diego, California, USA. flykarin@aol.com
Death of soldier linked to hazy vision after laser eye surgery
From the article: One of the four shooters, Staff Sgt. Trevor Alders, had recently had PRK laser eye surgery. Although he could see two sets of hands "straight up," his vision was "hazy," he said.
Post-LASIK night vision problems place Army soldiers at increased risk for injury or death
From a 2008 Walter Reed Army Medical Center study:
"Soldiers experiencing postoperative glare, haze, and starbursts could be significantly impaired in their ability to perform nighttime duties, thereby reducing the ability to perform their military functions safely. In a worst-case scenario, postoperative impairment of night vision may lead to increased risk for injury or even death."
Source: Jayson et al. Effect of brimonidine tartrate 0.15% on night-vision difficulty and contrast testing after refractive surgery. J Cataract Refract Surg. 2008 Sep;34(9):1538-41.
Air Force Lt. Col. Charles D. Reilly, MD: No traumatic flap dislocations after PRK
(4/6/2009) From the article: "U.S. Air Force personnel serving in Iraq and Afghanistan who underwent photorefractive keratectomy suffered no traumatic flap dislocations in a 1-year period."
Editor's note: Of course troops who underwent PRK suffered no flap dislocations -- there's no flap in PRK. Reilly goes on to state that post-PRK haze forced some troops to leave the theater.
Military physician serving in Iraq: LASIK testimonial
I am a military physician currently serving in a Troop Medical Clinic in Iraq, where I take care of sick and wounded soldiers and marines. Although I have been an Active Duty member of the Army during the entire period of Operation Iraqi Freedom, and have volunteered for combat zone duties throughout that time, this is my first deployment. Prior to this time, I have been medically unable to deploy, due to severe dry eye syndrome which was brought on by LASIK surgery. More »
Refractive surgery in the United States Air Force
Excerpt: "In 2008 at the Joint Warfighter Refractive Surgery Center, approximately 90% of refractive surgery candidates underwent surface ablation [including PRK, laser-assisted subepithelial keratomileusis (LASEK), and epi-LASIK]... PRK remains the most common refractive surgical procedure performed in the United States Air Force."
Source: Panday VA, Reilly CD. Refractive surgery in the United States Air Force. Curr Opin Ophthalmol. 2009 Apr 24.
Editor's note: Why do you suppose that 90% of refractive surgery performed in the Air Force is PRK, not LASIK? Could it be because LASIK flaps never heal?
Retired Navy Captain Steven C. Schallhorn, M.D. rejects "stack 'em high and sell’ em cheap" allegations
From the article: Mr. Michael O’Keeffe, consultant at the Mater and Temple Street Hospitals in Dublin, claims some of these clinics operate on the basis of "stack 'em high and sell’ em cheap" and are selling what is a complex and sometimes hazardous procedure as if they were selling “cans of beans or handbags.”... Dr. Schallhorn rejected Mr. O'Keeffe's assertion that having a doctor providing all the care is the best model.
Preliminary results of photorefractive keratectomy in active-duty United States Navy personnel
Excerpts from commentary by Leo J. Maguire, MD:
"If the mission is to give all troops 20/20 uncorrected photopic visual acuity 1 year after surgery, then the mission is accomplished-- at least in the first eyes of these two Navy SEALs and 28 other Navy personnel. If the mission is to provide a service that consistently preserves optical quality and accurately corrects refractive error, then we find casualties among the volunteers and some information missing in action".
"Unfortunately, we also have the postoperative minority with severe halos, severe glare, and disabling night vision -- all in a group with relatively low myopia. One can always discontinue contact lenses, but refractive surgery is forever."
"The results are mixed. The surgery is successful in the majority of patients, but the laser still takes prisoners. Upgrades in laser design and study protocols may eliminate these problems. Until then, the Navy should maintain the regulatory guard, and continue to gather intelligence".
Source: Schallhorn SC, Blanton CL, Kaupp SE, Sutphin J, Gordon M, Goforth H Jr, Butler FK Jr. Preliminary results of photorefractive keratectomy in active-duty United States Navy personnel. Ophthalmology. 1996 Jan;103(1):5-22.