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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Complications of ganciclovir implant surgery in patients with cytomegalovirus retinitis: the Ganciclovir Cidofovir Cytomegalovirus Retinitis Trial.
- James P Dunn, Mark Van Natta, Gregory Foster, Baruch D Kuppermann, Daniel F Martin, Alice Zong, Douglas A Jabs, and Studies of Ocular Complications of AIDS Research Group.
- Department of Ophthalmology, Wilmer Eye Institute, The Johns Hopkins University School of Medicine, 550 North Broadway, Baltimore, MD 21205, USA.
- Retina (Philadelphia, Pa.). 2004 Feb 1; 24 (1): 41-50.
PurposeTo describe the complications of ganciclovir implant surgery in patients with cytomegalovirus retinitis.MethodsProspective data collection within the context of a randomized, controlled clinical trial, comparing a regimen of the ganciclovir implant plus oral ganciclovir to one of intravenous cidofovir for the treatment of cytomegalovirus retinitis in patients with AIDS. Adverse events were compared for patients undergoing implant surgery in the following groups: primary versus replacement implant surgery, inpatient versus outpatient surgery, and general versus local anesthesia.ResultsFifty-six eyes of 42 patients underwent a total of 74 ganciclovir implant surgeries. Vitreous hemorrhage was the most common adverse event, occurring in 10% of eyes undergoing surgery with local anesthesia but in no eyes undergoing surgery with general anesthesia. All vitreous hemorrhages resolved within 60 days. Patients in the general anesthesia and inpatient surgery groups tended to have a lower risk of complications in the first 30 days than did patients in the local anesthesia and outpatient surgery groups, but no differences in the complication rate were found after 60 days. Visual acuity was similar among these different groups. There were no cases of endophthalmitis.ConclusionGanciclovir implant surgery in patients with AIDS and cytomegalovirus retinitis was associated with a low risk of serious complications in the first 60 days after surgery. Vitreous hemorrhage was the most commonly observed complication and resolved in all cases.
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