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A clinical trial supported by the National Eye Institute (NEI) hasfound that vitrectomy, a surgical procedure to replace the gel-likefilling inside the eye, need not be performed on approximately three-fourths of patients who develop a bacterial infection that mayoccur after eye surgery. The trial also found that antibiotics givenintravenously, for treating the same infection, provide no additionalbenefit over antibiotics given directly at the site of infection.
The infection, called endophthalmitis, causes an inflammation of theinterior of the eye. Although occurring in only 0.4 percent of the1.35 million people who have cataract surgery each year, the conditionis considered very serious because it may lead to blindness.
Carl Kupfer, MD, director of the NEI, part of the NationalInstitutes of Health, said the results of the clinical trial shouldmean fewer surgeries, and shorter or no hospital stays for as many as5,400 people each year. “This will result in potential savings ofabout $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 withinsix weeks following cataract surgery or secondary intraocular lensinsertion. The trial was designed to determine the role of immediatevitrectomy and intravenous antibiotics in the treatment ofendophthalmitis. All study patients received antibiotics injecteddirectly into the affected eye.
The EVS was conducted at 27 university-based clinical centers andprivate practices nationwide It was chaired by Bernard H. Doft, M.D.,of Retina Vitreous Consultants, Pittsburgh, and the University ofPittsburgh Medical Center, and the data was collected and analyzed bySheryl 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, forpatients with vision better than light perception, who could at leastsee a hand moving, the study found that immediate vitrectomy offeredno additional benefits over the injection of antibiotics into the eyeonly,” according to Doft.
“Vitrectomy was of major benefit only when patients had visionno better than light perception, as a result of the infection,”he continued. Light perception is the ability to merely distinguishbetween light and darkness. Among patients with light perception only,vitrectomy was three times more effective than a more minor procedurein achieving 20/40 vision.
He also said that although intravenous antibiotics have been usedfor many years to treat endophthalmitis, this study shows that theyare not necessary. Therefore, people may avoid not only potentially serious side effects but also the expense of the drugs and thehospital stay required to administer them. “In some cases,patients may never need to be hospitalized at all,” according toDoft.
Because these findings should lead to immediate public healthbenefits, the NEI has issued a clinical alert to more than 15,500ophthalmologists nationwide on the EVS findings. A scientific paperdetailing the study’s results was submitted to the Archives ofOphthalmologyfor expedited review, and will be published in theDecember 1995 issue of the journal.
The NEI is the Federal government’s lead agency for visionresearch, and supports more than 75 percent of such research conductedin 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