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The Serum Angiotensin Converting Enzyme and Lysozyme Levels in Patients Non-infectious and Infectious Uveitis (uveitis)

Primary Purpose

Sarcoidosis, Tuberculosis

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
spectrophotometric assay
radial immunodiffusion
Sponsored by
Ozlem Sahin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcoidosis focused on measuring Angiotensin converting enzyme, Lysozyme, Ankylosing spondylitis, Behcet's disease, Sarcoidosis, Syphilis, Tuberculosis, Ocular inflammation

Eligibility Criteria

9 Years - 86 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects have ocular inflammation diagnosed as sarcoidosis, ankylosing spondylitis, behcet's disease
  • Subjects have ocular infection diagnosed as tuberculosis and syphilis
  • Subjects have refractive errors only

Exclusion Criteria:

  • Subjects using ACE inhibitors, systemic steroids, immunosuppressive or immunomodulatory therapies

Sites / Locations

  • DunyaGoz hospital Tunus caddesi no.28 kavaklidereRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

serum angiotensin converting enzyme

serum lysozyme

Arm Description

spectrophotometric assay

radial immunodiffusion

Outcomes

Primary Outcome Measures

Analysis of serum angiotensin converting enzyme level

Secondary Outcome Measures

Analysis of serum lysozyme level

Full Information

First Posted
November 26, 2015
Last Updated
December 9, 2015
Sponsor
Ozlem Sahin
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1. Study Identification

Unique Protocol Identification Number
NCT02627209
Brief Title
The Serum Angiotensin Converting Enzyme and Lysozyme Levels in Patients Non-infectious and Infectious Uveitis
Acronym
uveitis
Official Title
Non-infectious and Infectious Uveitis Diagnosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ozlem Sahin

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates the significance of differences in serum angiotensin converting enzyme and lysozyme levels of patients with ocular involvement of other autoimmune inflammatory and infectious diseases.
Detailed Description
Increased serum levels of angiotensin converting enzyme and lysozyme are considered as inflammatory markers for diagnosis of sarcoidosis which is an autoimmune inflammatory disease. Sarcoidosis, ankylosing spondylitis and Behcet's disease are the most common autoimmune inflammatory diseases involving the eye. Elevated serum angiotensin converting enzyme levels have also been reported in tuberculosis. Syphilis and tuberculosis are the most common infectious diseases involving the eye.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis, Tuberculosis
Keywords
Angiotensin converting enzyme, Lysozyme, Ankylosing spondylitis, Behcet's disease, Sarcoidosis, Syphilis, Tuberculosis, Ocular inflammation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
serum angiotensin converting enzyme
Arm Type
Active Comparator
Arm Description
spectrophotometric assay
Arm Title
serum lysozyme
Arm Type
Active Comparator
Arm Description
radial immunodiffusion
Intervention Type
Other
Intervention Name(s)
spectrophotometric assay
Intervention Description
measurement of enzyme activity in the serum
Intervention Type
Other
Intervention Name(s)
radial immunodiffusion
Intervention Description
measurement of the precipitated ring diameters showing enzyme activity in the serum
Primary Outcome Measure Information:
Title
Analysis of serum angiotensin converting enzyme level
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Analysis of serum lysozyme level
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects have ocular inflammation diagnosed as sarcoidosis, ankylosing spondylitis, behcet's disease Subjects have ocular infection diagnosed as tuberculosis and syphilis Subjects have refractive errors only Exclusion Criteria: Subjects using ACE inhibitors, systemic steroids, immunosuppressive or immunomodulatory therapies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ozlem sahin, MD
Phone
90-537-5523064
Email
ozlem1158@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eda Karaismailoglu, MS
Phone
90-533-3097848
Email
edaozturk@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ioannis Pallikaris, MD
Organizational Affiliation
DunyaGoz Hospital, Etiler, yanarsu sokak no.1 besiktaş Istanbul Turkey
Official's Role
Study Chair
Facility Information:
Facility Name
DunyaGoz hospital Tunus caddesi no.28 kavaklidere
City
Cankaya
State/Province
Ankara
ZIP/Postal Code
06450
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ozlem sahin, MD
Phone
90-537-5523064
Email
ozlem1158@yahoo.com
First Name & Middle Initial & Last Name & Degree
eda karaismailoğlu, MS
Phone
90-533-3097848
Email
edaozturk@yahoo.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
21482866
Citation
Birnbaum AD, Oh FS, Chakrabarti A, Tessler HH, Goldstein DA. Clinical features and diagnostic evaluation of biopsy-proven ocular sarcoidosis. Arch Ophthalmol. 2011 Apr;129(4):409-13. doi: 10.1001/archophthalmol.2011.52.
Results Reference
result
PubMed Identifier
3508756
Citation
Sen DK, Sarin GS. Immunoassay of serum muramidase (lysozyme) in ocular diseases. Indian J Ophthalmol. 1987;35(5-6):103-7.
Results Reference
result
PubMed Identifier
26879979
Citation
Sahin O, Ziaei A, Karaismailoglu E, Taheri N. The serum angiotensin converting enzyme and lysozyme levels in patients with ocular involvement of autoimmune and infectious diseases. BMC Ophthalmol. 2016 Feb 16;16:19. doi: 10.1186/s12886-016-0194-4.
Results Reference
derived

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The Serum Angiotensin Converting Enzyme and Lysozyme Levels in Patients Non-infectious and Infectious Uveitis

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