A clinical trial supported by the National Eye Institute (NEI) has found that vitrectomy, a surgical procedure to replace the gel-like filling inside the eye, need not be performed on approximately three-fourths of patients who develop a bacterial infection that may occur after eye surgery. The trial also found that antibiotics given intravenously, for treating the same infection, provide no additional benefit over antibiotics given directly at the site of infection.
The infection, called endophthalmitis, causes an inflammation of the interior of the eye. Although occurring in only 0.4 percent of the1.35 million people who have cataract surgery each year, the condition is considered very serious because it may lead to blindness.
Carl Kupfer, MD, director of the NEI, part of the National Institutes of Health, said the results of the clinical trial should mean fewer surgeries, and shorter or no hospital stays for as many as 5,400 people each year. “This will result in potential savings of about $40 million annually in health care costs,” Kupfer said.
The clinical trial, called the Endophthalmitis Vitrectomy Study(EVS), involved 420 patients who had developed endophthalmitis within six weeks following cataract surgery or secondary intraocular lens insertion. The trial was designed to determine the role of immediate vitrectomy and intravenous antibiotics in the treatment of endophthalmitis. All study patients received antibiotics injected directly into the affected eye.
The EVS was conducted at 27 university-based clinical centers and private practices nationwide It was chaired by Bernard H. Doft, M.D., of Retina Vitreous Consultants, Pittsburgh, and the University of Pittsburgh Medical Center, and the data was collected and analyzed by Sheryl Kelsey, Ph.D., at the University of Pittsburgh.
Doft said that the overall visual results of the EVS were excellent, with over half of patients achieving 20/40 vision. “However, for patients with vision better than light perception, who could at least see a hand moving, the study found that immediate vitrectomy offered no additional benefits over the injection of antibiotics into the eye only,” according to Doft.
“Vitrectomy was of major benefit only when patients had a vision no better than light perception, as a result of the infection,” he continued. Light perception is the ability to merely distinguish between light and darkness. Among patients with light perception only, vitrectomy was three times more effective than a more minor procedure in achieving 20/40 vision.
He also said that although intravenous antibiotics have been used for many years to treat endophthalmitis, this study shows that they are not necessary. Therefore, people may avoid not only potentially serious side effects but also the expense of the drugs and the hospital stay required to administer them. “In some cases, patients may never need to be hospitalized at all,” according to Doft.
Because these findings should lead to immediate public health benefits, the NEI has issued a clinical alert to more than 15,500ophthalmologists nationwide on the EVS findings. A scientific paper detailing the study’s results was submitted to the Archives of ophthalmology for expedited review and will be published in the December 1995 issue of the journal.
The NEI is the Federal government’s lead agency for vision research and supports more than 75 percent of such research conducted in the United States.
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- Results of the Endophthalmitis Vitrectomy Study. A Randomized Trial of Immediate Vitrectomy and of Intravenous Antibiotics for The Treatment of Postoperative Bacterial Endophthalmitis. Endophtalmitis Vitrectomy Study Group. Arch Ophthalmol. 1995 Dec. PubMed