Endophthalmitis Vitrectomy Study (EVS)
Information source: National Eye Institute (NEI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endophthalmitis; Eye Infections
Intervention: Intravitreal Antibiotics (Drug); Initial Pars Plana Vitrectomy (Procedure)
Phase: Phase 3
Status: Completed
Sponsored by: National Eye Institute (NEI)
Summary
To determine the role of initial pars plana vitrectomy in the management of postoperative
bacterial endophthalmitis.
To determine the role of intravenous antibiotics in the management of bacterial
endophthalmitis.
To determine which factors, other than treatment, predict outcome in postoperative bacterial
endophthalmitis.
Clinical Details
Study design: Treatment, Randomized
Detailed description:
Endophthalmitis is a serious ocular infection that can result in blindness. Approximately 70
percent of cases occur as a direct complication of intraocular surgery. Current management
requires culture of intraocular contents and administration of an antibiotic. Vitrectomy
surgery, which may help to manage endophthalmitis by removing infecting organisms and their
toxins, has been shown to be of value in various animal models of endophthalmitis. However,
human studies have not shown an advantage to vitrectomy with intraocular antibiotics compared
with intraocular antibiotics alone.
In all large comparison studies to date, eyes with the worst initial presentations were the
ones selected for vitrectomy. Because of the selection bias involved in determining which
cases received vitrectomy, existing clinical information on the efficacy of the procedure for
treating endophthalmitis is inconclusive. Determining the role of initial vitrectomy and the
benefit or lack of benefit to certain subgroups of patients will help the clinician in the
management of endophthalmitis.
In addition, although systemic antibiotics have long been used in the management of
endophthalmitis, there has been little evidence to support their efficacy, but there have
been many reports of toxic systemic effects. In view of this, the role of systemic
antibiotics in the management of endophthalmitis will be assessed.
Endophthalmitis Vitrectomy Study (EVS) patients were randomized to one of two standard
treatment strategies for the management of bacterial endophthalmitis. Eyes received either
(1) initial pars plana vitrectomy with intravitreal antibiotics, followed by retap and
reinjection at 36-60 hours for eyes that did poorly as defined in the study or (2) initial
anterior chamber and vitreous tap/biopsy with injection of intravitreal antibiotics, followed
by vitrectomy and reinjection at 36-60 hours in eyes doing poorly. In addition, all eyes were
randomized to either treatment or no treatment with intravenous antibiotics.
Study end points were visual acuity and clarity of ocular media, the latter assessed both
clinically and photographically. Each patient's initial end point assessment occurred at 3
months, after which procedures to improve vision, such as late vitrectomy for nonclearing
ocular media, were an option. The final outcome assessment occurred at 9 months. Multiple
centers cooperated by enrolling 420 eyes during the 42-month recruitment period.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Men and women were eligible for entry into the EVS if they had clinical signs and symptoms
of bacterial endophthalmitis in an eye that had cataract surgery or lens implantation
within 6 weeks of onset of infection. The involved eye had to have either hypopyon or
enough clouding of anterior chamber or vitreous media to obscure clear visualization of
second-order arterioles, a cornea and anterior chamber in the involved eye clear enough to
visualize some part of the iris, and a cornea clear enough to allow the possibility of pars
plana vitrectomy. The eyes had to have a visual acuity of 20/50 or worse and light
perception or better.
Patients were ineligible when the involved eye was known at the time of study entry to have
had any pre-existing eye disease that limited best-corrected visual acuity to 20/100 or
worse before development of cataract, any intraocular surgery before presentation (except
for cataract extraction or lens implantation), any treatment for endophthalmitis before
presenting at the study center, or any ocular or systemic condition that would prevent
randomization to any of the study groups.
Locations and Contacts
Additional Information
Clinical Alert to Ophthalmologists NEI Press Release-New Treatment Options for People With Blinding Eye Infection
Related publications: Barza M, Pavan PR, Doft BH, Wisniewski SR, Wilson LA, Han DP, Kelsey SF. Evaluation of microbiological diagnostic techniques in postoperative endophthalmitis in the Endophthalmitis Vitrectomy Study. Arch Ophthalmol. 1997 Sep;115(9):1142-50. Doft BH; The Endophthalmitis Vitrectomy Study. Clinical Trials in Ophthalmology. A Summary and Practice Guide, Book Chapter published by Williams & Wilkins 1998:97-111 Johnson MW, Doft BH, Kelsey SF, Barza M, Wilson LA, Barr CC, Wisniewski SR. The Endophthalmitis Vitrectomy Study. Relationship between clinical presentation and microbiologic spectrum. Ophthalmology. 1997 Feb;104(2):261-72. Doft BH, Kelsey SF, Wisniewski S, Metz DJ, Lobes L, Rinkoff J, Davis M, Kassoff A. Treatment of endophthalmitis after cataract extraction. Retina. 1994;14(4):297-304. [No authors listed] Results of the Endophthalmitis Vitrectomy Study. A randomized trial of immediate vitrectomy and of intravenous antibiotics for the treatment of postoperative bacterial endophthalmitis. Endophthalmitis Vitrectomy Study Group. Arch Ophthalmol. 1995 Dec;113(12):1479-96. Doft BH, Barza M. Optimal management of postoperative endophthalmitis and results of the Endophthalmitis Vitrectomy Study. Curr Opin Ophthalmol. 1996 Jun;7(3):84-94. [No authors listed] Microbiologic factors and visual outcome in the endophthalmitis vitrectomy study. Am J Ophthalmol. 1996 Dec;122(6):830-46. Han DP, Wisniewski SR, Wilson LA, Barza M, Vine AK, Doft BH, Kelsey SF. Spectrum and susceptibilities of microbiologic isolates in the Endophthalmitis Vitrectomy Study. Am J Ophthalmol. 1996 Jul;122(1):1-17. Bannerman TL, Rhoden DL, McAllister SK, Miller JM, Wilson LA. The source of coagulase-negative staphylococci in the Endophthalmitis Vitrectomy Study. A comparison of eyelid and intraocular isolates using pulsed-field gel electrophoresis. Arch Ophthalmol. 1997 Mar;115(3):357-61. Doft BH; Managing infectious endophthalmitis: Results of the EVS., American Academy of Ophthalmology, Focal Points, 1997;XV No. 3 Wisniewski SR, Hammer ME, Grizzard WS, Kelsey SF, Everett D, Packo KH, Yarian DL, Doft BH. An investigation of the hospital charges related to the treatment of endophthalmitis in the Endophthalmitis Vitrectomy Study. Ophthalmology. 1997 May;104(5):739-45.
Starting date: February 1990
Last updated: June 1, 2006
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