Viewing Study NCT00000130



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Study NCT ID: NCT00000130
Status: COMPLETED
Last Update Posted: 2009-09-17
First Post: 1999-09-23

Brief Title: Endophthalmitis Vitrectomy Study EVS
Sponsor: National Eye Institute NEI
Organization: National Eye Institute NEI

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2009-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
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 tapbiopsy 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 patients 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None