Diagnostic Yield of Vitreous Biopsy in Sarcoid Uveitis - Full Text View

Sponsored by:	Duke University
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00609687

Purpose

The usefulness of diagnostic vitrectomy in patients with suspected sarcoidosis with posterior segment involvement (in whom a diagnosis cannot be determined by conventional methods) has not been well described. We hypothesized that diagnostic vitrectomy would help establish the diagnosis in these challenging cases. Herein, we evaluated the diagnostic yield of vitreous biopsy in patients with suspected sarcoidosis-associated uveitis that affected the posterior segment.This is a retrospective interventional case series. Cases of intermediate, posterior or panuveitis that could not be characterized by clinical examination, ancillary, and laboratory tests were considered for diagnostic pars plana vitrectomy. Retrospective chart review was conducted on consecutive eyes that underwent diagnostic, or diagnostic and therapeutic vitrectomy by a single surgeon from January 1989 to June 2006.

Condition	Intervention
Sarcoidosis-Associated Ocular Inflammation	Procedure: Diagnostic Vitrectomy

MedlinePlus related topics: Sarcoidosis

Drug Information available for: Temazepam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Diagnostic Yield of Vitreous Biopsy in Sarcoid Uveitis

Further study details as provided by Duke University:

Primary Outcome Measures:

To determine the diagnostic yield of vitreous biopsy in patients with suspected sarcoid uveitis [ Time Frame: January 1989 to June 2006 ] [ Designated as safety issue: No ]

Enrollment:	150
Study Start Date:	January 2007
Study Completion Date:	January 2008
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A Patients with suspected sarcoid-related posterior segment inflammation with inconclusive clinical exam findings, ancillary testing, and laboratory results	Procedure: Diagnostic Vitrectomy Three-port, 20-gauge pars plana vitrectomy instrumentation was utilized. An infusion line was inserted into one sclerotomy and secured to the globe. A second sclerotomy was made, and a fiberoptic light pipe was immediately inserted to minimize vitreous egress. A third sclerotomy was created, and the vitreous cutter was inserted. To obtain an undiluted vitreous sample, the vitreous was cut mechanically with the vitreous cutter, while the assistant surgeon simultaneously manually aspirated the vitreous. After sufficient undiluted sample was obtained, infusion fluid was allowed to enter the eye and a diluted vitreous sample was obtained in a similar manner. The samples were personally carried to the clinical laboratories by the operating surgeon. Vitreous fluid analysis was guided by clinical suspicion based on the pre-operative differential diagnosis and the intraoperative posterior segment appearance.

Arms

Assigned Interventions

A

Patients with suspected sarcoid-related posterior segment inflammation with inconclusive clinical exam findings, ancillary testing, and laboratory results

Procedure: Diagnostic Vitrectomy

Three-port, 20-gauge pars plana vitrectomy instrumentation was utilized. An infusion line was inserted into one sclerotomy and secured to the globe. A second sclerotomy was made, and a fiberoptic light pipe was immediately inserted to minimize vitreous egress. A third sclerotomy was created, and the vitreous cutter was inserted. To obtain an undiluted vitreous sample, the vitreous was cut mechanically with the vitreous cutter, while the assistant surgeon simultaneously manually aspirated the vitreous. After sufficient undiluted sample was obtained, infusion fluid was allowed to enter the eye and a diluted vitreous sample was obtained in a similar manner. The samples were personally carried to the clinical laboratories by the operating surgeon.

Vitreous fluid analysis was guided by clinical suspicion based on the pre-operative differential diagnosis and the intraoperative posterior segment appearance.

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Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Cases were included if intraocular vitreous specimens were obtained for diagnostic testing.

Exclusion Criteria:

Patients with acute postoperative or traumatic endophthalmitis from this study were excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609687

Locations

United States, North Carolina
Duke University Eye Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator:

Glenn J Jaffe, MD

Duke University Eye Center

More Information

Publications of Results:

Mruthyunjaya P, Jumper JM, McCallum R, Patel DJ, Cox TA, Jaffe GJ. Diagnostic yield of vitrectomy in eyes with suspected posterior segment infection or malignancy. Ophthalmology. 2002 Jun;109(6):1123-9.

Responsible Party:	Duke University Eye Center ( Glenn J. Jaffe, MD )
Study ID Numbers:	9351-07-1R0ER
Study First Received:	January 25, 2008
Last Updated:	February 6, 2008
ClinicalTrials.gov Identifier:	NCT00609687
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

sarcoidosis
diagnostic vitrectomy
vitreous biopsy
sarcoidosis-associated ocular inflammation

Study placed in the following topic categories:

Lymphatic Diseases
Uveitis
Eye Diseases
Temazepam

Sarcoidosis
Lymphoproliferative Disorders
Inflammation

Additional relevant MeSH terms:

Uveal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009