Sarcoidosis-associated Ocular InflammationNCT00609687
Diagnostic Yield of Vitreous Biopsy in Sarcoid Uveitis
A study testing Diagnostic Vitrectomy in people with Sarcoidosis-associated Ocular Inflammation, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoidosis-associated Ocular Inflammation
- What is being tested?
- Diagnostic Vitrectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jan 2008
- Phase
- Interventional
- 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
Who may be able to join
- Cases were included if intraocular vitreous specimens were obtained for diagnostic testing.
Who cannot join
- Patients with acute postoperative or traumatic endophthalmitis from this study were excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Eye Center
Durham, North Carolina, 27710
About this study
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.
Read the detailed description
We obtained approval to conduct this non-comparative, interventional, retrospective case series from the Duke University Institutional Review Board. We used an established database of patients with uveitis and the operative reports from a single surgeon (GJJ) to identify all consecutive patients who underwent diagnostic pars plana vitrectomy from January 1989 to June 2006. We excluded patients with acute postoperative or traumatic endophthalmitis from this study. Cases were included if intraocular vitreous specimens were obtained for diagnostic testing. After identifying 150 patients, we reviewed the medical records of these individuals as previously described.
Patient demographic data and clinical history were recorded at the time of initial visit. A complete ophthalmic history and examination were performed by a single examiner (GJJ). The examination included slit-lamp biomicroscopy and dilated fundus examination with indirect ophthalmoscopy. Anterior segment inflammation was graded using the system described by Hogan and colleagues. The system previously described by Nussenblatt et.al. was used to grade vitreous opacity. Fluorescein angiography, optical coherence tomography, and ultrasonography were performed as indicated. A differential diagnosis was compiled for each case, based on clinic findings. Additional laboratory tests were ordered depending on the constellation of clinical history, exam findings, and results of previous ancillary testing. Anti-inflammatory therapy was initiated in an empiric or diagnosis-specific manner, and the clinical response was followed carefully.
Diagnostic vitrectomy was performed on eyes with intermediate, posterior, or panuveitis in which an etiology could not be characterized by clinical examination, laboratory, and/or ancillary testing. In addition, diagnostic vitrectomy was performed on eyes that did not adequately respond to empirical therapy, or those in which intraocular malignancy or infection was suspected. Therapeutic vitrectomy was performed in conjunction with diagnostic vitrectomy when clinically indicated, for example to repair retinal detachment, to remove epiretinal membranes, to decrease vitreous opacity, or to insert an intraocular sustained drug-delivery implant.
In this study, vitreous samples were collected in the operating room using a standardized technique which has been previously reported. Briefly, 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. The tip of the vitreous cutter was viewed at all times with the wide-field viewing system during the procedure. 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. Cytopathology was used to identify granulomatous inflammation or tumor cells. A thin-prep was prepared, processed through a membrane filter apparatus (Millipore Corp, Bedford, MA) and then stained with Papanicolaou stain. Gram stain, KOH preparation and culture were used to diagnose intraocular infection. Where appropriate, instructions were given to the clinical laboratory for specific sample processing (e.g., suspected slow-growing bacterium, such as Propionibacterium acnes or suspected fungal infection). Genomic amplification by polymerase chain reaction (PCR) was performed at the University of Colorado (Boulder, CO), or Texas Children's Hospital (Houston, TX) to test for the presence of Herpes simplex virus, Herpes zoster virus, and cytomegalovirus. PCR was performed for Toxoplasma gondii at the Palo Alto Medical Foundation (Palo Alto, CA) as previously described. Toxocara canis antibody levels were detected by enzyme-linked immunosorbent assay (ELISA) at the Centers for Disease Control and Prevention (Atlanta, GA). For Toxoplasma gondii and Toxocara canis, simultaneous serum samples were also collected and sent to the respective laboratories.
The final diagnosis was based upon the results of the directed diagnostic testing of the vitreous sample. A positive diagnostic vitrectomy result was based upon the identification of a specific etiologic agent through the testing modalities previously described. Sarcoidosis is a diagnosis of exclusion without a known etiologic agent. There are no definitive laboratory tests that unequivocally confirm a diagnosis of sarcoid. Therefore, a diagnostic specimen was deemed positive for sarcoid-related inflammation if the following criteria were satisfied: 1) if all other vitreous testing was negative 2) if the clinical features were such that sarcoidosis was included in the differential diagnosis based on pre-operative clinical appearance, and 3) if the cytopathology specimen was consistent with a pattern of sarcoid-related inflammation such as non-caseating granuloma formation, as established by the cytopathologist.
- Being tested
- Diagnostic Vitrectomy
- Keywords
- sarcoidosis, diagnostic vitrectomy, vitreous biopsy, sarcoidosis-associated ocular inflammation
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic VitrectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Patients with suspected sarcoid-related posterior segment inflammation with inconclusive clinical exam findings, ancillary testing, and laboratory results Receives: Procedure: Diagnostic Vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the diagnostic yield of vitreous biopsy in patients with suspected sarcoid uveitis
Measured: January 1989 to June 2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startJan 2007
- Primary completionOct 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sarcoidosis-associated Ocular InflammationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glenn J Jaffe, MD, Principal investigator, Duke University Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609687
- Sponsor's protocol ID
- Pro00014310
- Status last verified
- Jan 2008
- First submitted
- 25 Jan 2008
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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. doi: 10.1016/s0161-6420(02)01033-3.
PubMed 12045054Scott AW, Mruthyunjaya P, McCallum RM, Jaffe GJ. Diagnostic yield of vitreous biopsy in presumed sarcoidosis-related posterior segment inflammation. Graefes Arch Clin Exp Ophthalmol. 2012 Sep;250(9):1379-85. doi: 10.1007/s00417-012-1993-9. Epub 2012 Mar 21.
PubMed 22434211
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Yield of Vitreous Biopsy in Sarcoid Uveitis
- ClinicalTrials.gov ID
- NCT00609687
- Acronym / sponsor ID
- Pro00014310
- Keywords
- sarcoidosis, diagnostic vitrectomy, vitreous biopsy, sarcoidosis-associated ocular inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 7 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We obtained approval to conduct this non-comparative, interventional, retrospective case series from the Duke University Institutional Review Board. We used an established database of patients with uveitis and the operative reports from a single surgeon (GJJ) to identify all consecutive patients who underwent diagnostic pars plana vitrectomy from January 1989 to June 2006. We excluded patients with acute postoperative or traumatic endophthalmitis from this study. Cases were included if intraocular vitreous specimens were obtained for diagnostic testing. After identifying 150 patients, we reviewed the medical records of these individuals as previously described.
Patient demographic data and clinical history were recorded at the time of initial visit. A complete ophthalmic history and examination were performed by a single examiner (GJJ). The examination included slit-lamp biomicroscopy and dilated fundus examination with indirect ophthalmoscopy. Anterior segment inflammation was graded using the system described by Hogan and colleagues. The system previously described by Nussenblatt et.al. was used to grade vitreous opacity. Fluorescein angiography, optical coherence tomography, and ultrasonography were performed as indicated. A differential diagnosis was compiled for each case, based on clinic findings. Additional laboratory tests were ordered depending on the constellation of clinical history, exam findings, and results of previous ancillary testing. Anti-inflammatory therapy was initiated in an empiric or diagnosis-specific manner, and the clinical response was followed carefully.
Diagnostic vitrectomy was performed on eyes with intermediate, posterior, or panuveitis in which an etiology could not be characterized by clinical examination, laboratory, and/or ancillary testing. In addition, diagnostic vitrectomy was performed on eyes that did not adequately respond to empirical therapy, or those in which intraocular malignancy or infection was suspected. Therapeutic vitrectomy was performed in conjunction with diagnostic vitrectomy when clinically indicated, for example to repair retinal detachment, to remove epiretinal membranes, to decrease vitreous opacity, or to insert an intraocular sustained drug-delivery implant.
In this study, vitreous samples were collected in the operating room using a standardized technique which has been previously reported. Briefly, 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. The tip of the vitreous cutter was viewed at all times with the wide-field viewing system during the procedure. 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. Cytopathology was used to identify granulomatous inflammation or tumor cells. A thin-prep was prepared, processed through a membrane filter apparatus (Millipore Corp, Bedford, MA) and then stained with Papanicolaou stain. Gram stain, KOH preparation and culture were used to diagnose intraocular infection. Where appropriate, instructions were given to the clinical laboratory for specific sample processing (e.g., suspected slow-growing bacterium, such as Propionibacterium acnes or suspected fungal infection). Genomic amplification by polymerase chain reaction (PCR) was performed at the University of Colorado (Boulder, CO), or Texas Children's Hospital (Houston, TX) to test for the presence of Herpes simplex virus, Herpes zoster virus, and cytomegalovirus. PCR was performed for Toxoplasma gondii at the Palo Alto Medical Foundation (Palo Alto, CA) as previously described. Toxocara canis antibody levels were detected by enzyme-linked immunosorbent assay (ELISA) at the Centers for Disease Control and Prevention (Atlanta, GA). For Toxoplasma gondii and Toxocara canis, simultaneous serum samples were also collected and sent to the respective laboratories.
The final diagnosis was based upon the results of the directed diagnostic testing of the vitreous sample. A positive diagnostic vitrectomy result was based upon the identification of a specific etiologic agent through the testing modalities previously described. Sarcoidosis is a diagnosis of exclusion without a known etiologic agent. There are no definitive laboratory tests that unequivocally confirm a diagnosis of sarcoid. Therefore, a diagnostic specimen was deemed positive for sarcoid-related inflammation if the following criteria were satisfied: 1) if all other vitreous testing was negative 2) if the clinical features were such that sarcoidosis was included in the differential diagnosis based on pre-operative clinical appearance, and 3) if the cytopathology specimen was consistent with a pattern of sarcoid-related inflammation such as non-caseating granuloma formation, as established by the cytopathologist.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Other | Procedure: Diagnostic VitrectomyPatients with suspected sarcoid-related posterior segment inflammation with inconclusive clinical exam findings, ancillary testing, and laboratory results |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Cases were included if intraocular vitreous specimens were obtained for diagnostic testing.
Key exclusion criteria (1 listed)
- Patients with acute postoperative or traumatic endophthalmitis from this study were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic VitrectomyThree-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. | Procedure or surgery | A |
Primary outcome
To determine the diagnostic yield of vitreous biopsy in patients with suspected sarcoid uveitis
Time frame: January 1989 to June 2006
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2013.
- Results publication: PubMed 12045054Mruthyunjaya 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. doi: 10.1016/s0161-6420(02)01033-3.
- Derived from this study: PubMed 22434211Scott AW, Mruthyunjaya P, McCallum RM, Jaffe GJ. Diagnostic yield of vitreous biopsy in presumed sarcoidosis-related posterior segment inflammation. Graefes Arch Clin Exp Ophthalmol. 2012 Sep;250(9):1379-85. doi: 10.1007/s00417-012-1993-9. Epub 2012 Mar 21.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn J Jaffe, MD principal investigator
Duke University Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Vitrectomy in people with Sarcoidosis-associated Ocular Inflammation, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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.
What does the primary outcome measure?
To determine the diagnostic yield of vitreous biopsy in patients with suspected sarcoid uveitis (time frame: January 1989 to June 2006). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00609687, which also lists 2 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 11 Apr 2013.