AAO Panel Offers Insight on Treatment Recommendations, In-Office Retina Surgery

Experts in ophthalmology gathered at the American Academy of Ophthalmology annual meeting to speak on the future of in-office retina surgery and how to determine when to recommend experimental surgeries for patients. The session, entitled “Public Health, Education, and the Business of Retina,” covered these and other topics to kickstart the 4-day conference.

Minimally Proven Treatment Recommendation: When to Offer Experimental Treatment

Paul Sternberg Jr, MD, chairman of the Vanderbilt Eye Institute, began with a presentation on the value and caution doctors should consider for experimental ophthalmic treatments when it comes to caring for their patients. Sternberg said that the question of when to offer a minimally proven treatment should be a question that everyone asks.

“Over the years, how many of us have returned from meetings like this, learned about a new treatment, and then begun offering it to some of our patients?” he said. “I know that I have.”

Sternberg gave an example of a meeting from 2005 in which data were presented on how ranibizumab was successfully used to treat neovascular age-related macular degeneration in a small group of patients. He said that he immediately jumped on board for the idea, even though the treatment was minimally proven and had already helped numerous patients prior to this becoming a proven treatment for the disease.

He countered this positive example with a minimally proven treatment that did not work, when data from 2001 suggested that radial optic neurotomy, which creates a radial incision on the navel side of the optic nerve with the idea that it would alleviate neurovascular compression, could be used to treat central retinal vein occlusion. Sternberg said that he began offering his patients this surgery, but its benefits were never proven.

Up to 15% of all medicine prescriptions, he continued, are “off-label with little to no scientific support.” Patients who have not seen success in proven therapies are more likely to have hope for investigational therapies. However, some of these treatments may risk a patient’s vision and should be administered with caution.

Sternberg said that doctors should make informed decisions based on present treatments for ophthalmic issues and whether they are effective or not.

“We have to remind ourselves that this is about the patients and not about us,” he said. “The excitement of offering something new and potentially transformative has to be balanced with the learning curve for the procedure. We cannot take advantage of the patient’s desperation for transformative treatment.”

He concluded by saying that doctors should only offer these treatments if there is significant benefit over existing treatment, the procedure does not carry undue risk to the patient, and the doctor is qualified to do the treatment and has transparency with the patient about potential risks and benefits.

In-Office Retinal Surgery: Is It on the Horizon?

Tarek S. Hassan, MD, professor of ophthalmology at Oakland University William Beaumont School of Medicine, followed with a presentation on the future of in-office retinal surgery.

“The 25-year-old question about, ‘Is there a future for office space retinal surgery?’ is really a definite probably,” said Hassan, comparing the move to office space retinal surgery with the move from hospital to ambulatory center eye surgery.

Intraocular surgery in office spaces has faced hurdles to more widespread acceptance. These hurdles include safety and sterility, regulation and oversight, space and equipment, reimbursement, and efficacy.

Office-based retinal surgery has occurred, showing that the procedure is possible; however, there is no industry involvement and no reimbursement for such procedures, which has made widespread adoption difficult. Hassan said that office-based eye surgery is most commonly cataract and refractive, with 50 to 75 office-based cataract surgery sites in the United States.

Patient safety and regulatory oversight are also concerns for office-based eye surgery. Many eye procedures are not “routine," patients may need anesthesia requiring a anesthetist or doctor, and office surgery suites will need to be accredited by the same organizations that accredit ambulatory center eye surgeries and hospital operating rooms.

Space and equipment for office-based surgery is another a hurdle for doctors, as a surgical suite would require a significant amount of space, great expense, and a long-lasting commitment. Hassan suggests that creating a sterile room condition in existing or smaller office spaces could make this less of a hurdle by using a portable horizontal laminar flow heap-filtered air system.

Reimbursement was pointed out as the biggest hurdle for many doctors when considering office-based surgery.

“Generally, there’s no facility fee that’s paid for office space surgery, so surgical overhead costs are not covered,” said Hassan. “Office-based proponents are seeking a larger total payment to demonstrate cost savings if there’s no anesthesia facility fee.”

“Office-based surgery can be done safely. And of course, there are concerns. Of course, potential solutions do exist. And through regulatory guidelines, we could probably get a situation where office-based surgery is done in situations that are equivalent to [ambulatory center eye surgeries] and hospitals,” Hassan concluded. “Reimbursement and industry commitment to development investment are the keys to this going forward.”