When I was a military ophthalmologist, my practice often received phone calls from soldiers determined to undergo refractive surgery during a tight window between deployments overseas. I vividly recall one such phone call from a sergeant major completing his third deployment overseas. He said that his glasses had gotten dirty, sweaty, broken, and in the way one too many times. He stated in no uncertain terms that he was going to have refractive surgery prior to his next deployment no matter what I told him. This was a common theme, and my staff and I assured him that we would get him in for LASIK as soon as he was back home.
AT A GLANCE
• Participating in clinical research provides options to patients when the currently available technologies are insufficient.
• Patients’ enthusiasm about participating in clinical research can strengthen a practice’s reputation through word-of-mouth referrals.
• Choose studies you believe in, where you will want to offer the technology or procedure to patients once it is approved.
Three months later at the eye clinic, after carefully reviewing the patient’s corneal topography measurements, I had the unfortunate task of informing him that his corneas were too thin for laser vision correction. “You don’t understand,” he responded. “I’m not going back out there with these -8.00 [D] glasses. It’s not safe.” He feared for his life, and his bulging muscles and clenched jaw made me begin to fear for mine!
What does this have to do with clinical research? Around that same time, the availability of phakic IOLs had increased as a result of the FDA’s recent approval of the Visian ICL (STAAR Surgical) for the correction of myopia. This patient had plenty of anterior chamber depth, and I wondered if a phakic IOL would be a viable option for him. The answer was unclear. There was a paucity of data on the performance of phakic IOLs in military service members at the time. These brave servicemen and women jump in and out of foxholes, knock down doors, run through woods, and are exposed to every kind of extreme physical environment imaginable.
I decided to seek approval from my Institutional Review Board to analyze the clinical outcomes of phakic IOLs in military service members in a controlled setting with close follow-up. This was my first foray into clinical research, and it has opened up a whole new thrilling side of clinical practice for me.
When I consider participating in a clinical trial, I ask myself a few questions. First, does the new procedure or pharmaceutical serve an unmet need for patients? Do currently available data support reasonable safety and effectiveness of the procedure or device? Based on what is known, do I believe in the technology, and will I recommend it to patients once it is approved? If my answer to all of those is yes, then I jump in.
BENEFITS FOR PATIENTS
When currently available technologies are insufficient, clinical research can provide patients with access to new options. I recall a sweet glaucoma patient of mine whose visual field loss was significant a few years ago. Medical therapy was not controlling her IOP satisfactorily, and she had already undergone selective laser trabeculoplasty. The patient swore she was instilling her drops religiously. At one of her follow-up appointments, I asked her to show her medication to me. To my amazement, she had been squeezing an empty bottle of latanoprost for quite some time. No wonder her IOP was still elevated!
As a cataract and refractive surgeon, I have never been a huge fan of managing tubes and trabeculectomies, but microinvasive glaucoma surgery devices seemed like a possible solution for this patient and many like her in my practice. My practice became involved in clinical trials for devices for microinvasive glaucoma surgery to help address an unmet need that many of our patients had at that time.
BENEFITS FOR A PRACTICE
Because participating in clinical trials provides more options and is good for my patients, it is also good for my practice. Many patients are excited about advancing science. My practice now participates in several clinical trials funded by Glaukos and other companies. A great number of my glaucoma patients who are currently enrolled in clinical trials mention that they understand that glaucoma has a hereditary link. They are enthusiastic to be involved in research that may benefit not only themselves but also their children and grandchildren. Because of clinical research, they tell their family, friends, and referring doctors that my practice is the place to go for a vast array of cutting-edge options related to their eyes and vision. This creates a recipe for growth and expansion.
On a recent cataract mission in an undeveloped part of the world, I was reminded of yesteryear’s technologies. I thought of how much better off my patients and practice are now, thanks in part to ophthalmologists who advanced the art and science of ophthalmology by pushing limits and expanding treatment modalities. I strongly recommend that ophthalmologists interested in performing clinical research apply the questions I mentioned earlier to the technologies they think may benefit their patients and jump in to provide more options.
Gregory D. Parkhurst, MD
• founder and physician CEO, Parkhurst-Nuvision, San Antonio, Texas
• (210) 615-9358; firstname.lastname@example.org; Twitter @PNuVision and @gregparkhurstmd
• financial disclosure: consultant to Glaukos and STAAR Surgical