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Louis W. Sullivan, Secretary of Health and Human Services, hasannounced results of a clinical trial demonstrating a 50 percentimprovement in surgical control of glaucoma in patients at high riskfor blindness. In the Fluorouracil Filtering Surgery Study (FFSS),glaucoma surgery was followed by injections of the drug,5-fluorouracil (5-FU), beneath the outer membrane of the eye. 5-FU isused to impede the growth of scar tissue that may reverse the surgery’sbeneficial effect. The FFSS study was supported by the National EyeInstitute (NEI), a component of the National Institutes of Health.
Open-angle glaucoma, the most common form of glaucoma in America, isone type of the disease studied in the FFSS. It is the second leadingcause of blindness among all Americans and the leading cause amongblacks. The disease is characterized by an abnormal, progressive risein fluid pressure inside the eye, which gradually damages the opticnerve. Most patients can control their glaucoma with medications thateither reduce fluid production or facilitate its outflow, but whendrops or pills fail, some patients need filtering surgery to provide anew fluid outlet to lower their pressure. Sometimes, however, scartissue blocks the outlet channel, necessitating further surgery. Thistype of surgery is least successful in patients who have had aprevious filtering surgery or who have had cataracts removed.
To determine whether postoperative injections of 5-fluorouracil alsocalled 5-FU, could enhance the success of filtering surgery,investigators from seven clinical centers recruited 213 high-riskglaucoma patients for the FFSS. After the investigators performed thesurgery and determined that the new outlet was working, the patientswere randomized to receive either 5-FU injections or to receivestandard post-surgical care without 5-FU.
The study was scheduled to end in 1990, but patient recruitment wasstopped in June 1988 when it become evident that the combination ofsurgery and 5-FU therapy was significantly superior to the surgeryalone. When the study’s Safety and Data Monitoring Committee hadaccumulated 1-year followup data, they found nearly a 50 percentimprovement in the outcome of operations that were followed by 5-FUinjections. Of the 105 operations on eyes treated with 5-FU, 73percent were successful at one year compared to 50 percent of the 108eyes in the standard therapy group.
Filtering surgery followed by postoperative injections of 5-FUprovided an additional benefit. Two-thirds of the patients receivingtreatment with 5-FU did not need to resume taking medications tocontrol their glaucoma. In the standard therapy group, only aboutone-third maintained satisfactory pressure control without medication.Moreover, of those requiring medication after surgery, patients in the5-FU group needed fewer types and lower doses of medication that thosein the standard treatment group.
The quality of life generally improved for patients receiving 5-FUbecause they were less likely to require further surgery and neededfewer or no daily medications. However, the 5-FU injections giventwice daily for the first week and daily the second week, sometimescaused side effects. These side effects were usually short-lived, andthe patients tolerated them without substantial problems.
Study chairman Richard K. Parrish, II, M.D., Associate Professor ofOphthalmology at the Bascom Palmer Eye Institute, University of MiamiSchool of Medicine, said, “We will follow these patients for atleast five years to determine whether the early results hold true. Nowthat we know 5-FU improves the short-term outcome for these patients,we can investigate whether lower doses of 5-FU or less rigorousinjection schedules may produce the same or even better results.”
NEI Director, Carl Kupfer, M.D., is optimistic about how well theearly results will hold up. “If a filtering surgery is providingdrainage after one year, it probably will continue to do so for a longtime. And if 5-FU improves surgical results for these high-riskpatients, it may also improve outcome for patients who have a lowerrisk for surgical failure.”
James Mason, M.D., Assistant Secretary for Health, said, “Theseresults are very encouraging since filtering surgery is often the lasthope for preventing further visual loss from glaucoma.”
Study results have been published in the December 1989 issue of theAmerican Journal of Ophthalmology.
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- Fluorouracil Filtering Surgery Study One-Year Follow-Up. The Fluorouracil Filtering Surgery Study Group. Am J Ophthalmol. 1989 Dec 15. PubMed