STOCKHOLM — What may be the largest study of an in-office procedure to repair the most common type of retinal detachment has shown real-world outcomes lag far behind those reported in a pivotal clinical trial. Eyes that have undergone cataract surgery have almost a 50% failure rate, according to results presented at the American Society of Retina Specialists (ASRS) 2024 Annual Meeting on July 17, 2024, in Stockholm, Sweden.
"Have we gotten better at pneumatic retinopexy from 2012 to 2022 with our success? The answer is no," Gaurav Shah, MD, a retina specialist at the West Coast Retina Medical Group in San Francisco, said while presenting the results.
Alternative to Conventional Procedures
The in-office procedure, pneumatic retinopexy, is used to repair rhegmatogenous retinal detachments (RRDs), which occur when fluid under the retina causes it to detach from the wall of the eye. In addition to not requiring an operating room, pneumatic retinopexy has other potential advantages over conventional RRD repair. It requires local, not systemic, anesthesia, the incisions are small, and the procedure has been shown to speed recovery surgery.
Conventional procedures include pars plana vitrectomy and scleral buckle.
Shah and his colleagues conducted a study of 16,668 eyes that underwent pneumatic retinopexy for RRD from 2013 to 2022 from the Intelligent Research in Sight (IRIS) registry database maintained by the American Academy of Ophthalmology.
The single-operation success rate was 59.41%, far below the 80.8% success rate investigators for the PIVOT study reported in 2018. A later study of 9553 pneumatic retinopexy procedures reported a success rate of 68.5% for single operations.
In the latest analysis, for eyes that had cataract surgery, the results were worse: A 54% success for single operations and 63.5% success for eyes that did not have previous cataract surgery, Shah said.
Almost one third (32%) of all patients in the study required a second procedure, which consisted of either repeat pneumatic retinopexy, scleral buckle, vitrectomy with or without scleral buckle, or complex retinal detachment repair; 6.9% needed two procedures and 0.7% underwent three surgeries.
Other complications the researchers reported were epiretinal membrane, accounting for 43.4% of adverse events, followed by vitreous hemorrhage at 10.4%.
In the PIVOT study, 89% of patients also received laser treatment within 2 weeks of the procedure to reattach the retina, 24% received cryotherapy, and 8% received an additional injection of gas to create a bubble to reattach the retina.
Patient Selection Key
"Pneumatic retinopexy is an important part of what we do every day but with the notion that we have to let patients know, in the way that it's currently being done in the United States. With most people there is a two-in-three chance of success in phakic eyes," Shah told Medscape Medical News.
"We might be able to increase our success rate with proper case selection, better techniques, and better training and emulate the success that was noted in the single-center PIVOT trial," he added. "If somebody has had cataract surgery, there's almost a one-in-two chance of success."
Patients who have had cataract surgery must be aware of other procedures, Shah said. "So you have the choice of maybe doing a more invasive procedure to get a better one-operation success rate."
The reason eyes that did not have cataract surgery fared better than eyes that did is because the implanted lens sometimes develops fibrosis in the capsule that can obscure the surgeon's view of small breaks in the retina.
"In pseudophakic eyes it's sometimes difficult to see all the retinal tears; they're tiny, and people have capsular opacification that sometimes makes it hard to see all the breaks," Shah said.
The study provides important points for retina surgeons counseling patients with RRD, especially since the real-world data vary so widely from the findings of the PIVOT study, said Sunir Garg, MD, codirector of retina research at Wills Eye Hospital in Philadelphia.
"In the clinical study, there's going to be more strict inclusion and exclusion criteria for patients, and the practice pattern and treatment algorithms that were used in the clinical study may differ than what's typically done in routine clinical practice," he said.
He also noted that the PIVOT study included laser treatment, cryotherapy, and a high number of laser spots — an average of 990 per patient. "The amount of laser spots they did was a lot higher than would be needed to just treat a retinal tear alone, so they were probably treating other areas in the retina as well, and that I think is different than a lot of practitioners in the United States usually do, and that may have affected the results as well," he said.
A study strength is that it drew on the IRIS registry, a database Garg called "really robust" and that it studied procedures over 9 years. But a limitation inherent in registry data is the lack of "patient-level granular data," along with the lack of detail on surgeon experience and how many were emergency surgeries, he said. The 10% of procedures performed by nonspecialists were "an unreasonable number of eyes," he added.
The Ophthalmic Mutual Insurance Company through the Bruce Spivey fund provided funding for the study. Shah disclosed having financial relationships with ZEISS and Regeneron Pharmaceuticals. Garg reported having financial relationships with the American Academy of Ophthalmology, Bausch + Lomb, and Allergan/AbbVie.
Richard Mark Kirkner is a medical journalist based in the Philadelphia area.
