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EndophthalmitisPhase 3NCT00000130

Endophthalmitis Vitrectomy Study (EVS)

A Phase 3 study testing Intravitreal Antibiotics and Initial Pars Plana Vitrectomy in people with Endophthalmitis and Eye Infections, run by National Eye Institute (NEI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Endophthalmitis, Eye Infections
What is being tested?
Intravitreal Antibiotics and Initial Pars Plana Vitrectomy
Type of treatment
Surgery or procedure
How many people
Not given
Where
No sites listed yet
Study dates
Feb 1990to Jan 1995
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

About this study

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.

Read the 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.

Being tested
Intravitreal Antibiotics, Initial Pars Plana Vitrectomy
Keywords
Bacterial Endophthalmitis
Medical subject headings
Endophthalmitis, Eye Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravitreal AntibioticsDrug

  • Initial Pars Plana VitrectomyProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 1999 (estimated)
  2. Study startFeb 1990
  3. Study completionJan 1995

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000130
Sponsor's protocol ID
NEI-29
Status last verified
Sep 2009
First submitted
23 Sep 1999
Last updated
17 Sep 2009
Results posted
No

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. doi: 10.1001/archopht.1997.01100160312008.

    PubMed 9298055

  • 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. doi: 10.1016/s0161-6420(97)30326-1.

    PubMed 9052630

  • 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. doi: 10.1097/00006982-199414040-00002.

    PubMed 7817022

  • 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.

    PubMed 7487614

  • 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. doi: 10.1097/00055735-199606000-00015.

    PubMed 10163467

  • Microbiologic factors and visual outcome in the endophthalmitis vitrectomy study. Am J Ophthalmol. 1996 Dec;122(6):830-46. doi: 10.1016/s0002-9394(14)70380-0.

    PubMed 8956638

  • 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. doi: 10.1016/s0002-9394(14)71959-2.

    PubMed 8659579

  • 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. doi: 10.1001/archopht.1997.01100150359008.

    PubMed 9076208

  • 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. doi: 10.1016/s0161-6420(97)30239-5.

    PubMed 9160017

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intravitreal Antibiotics and Initial Pars Plana Vitrectomy in people with Endophthalmitis and Eye Infections, run by National Eye Institute (NEI).

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000130, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2009.

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