NCT02627209

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

December 10, 2015

Status Verified

December 1, 2015

Enrollment Period

1.7 years

First QC Date

November 26, 2015

Last Update Submit

December 9, 2015

Conditions

SarcoidosisTuberculosis

Keywords

Angiotensin converting enzymeLysozymeAnkylosing spondylitisBehcet's diseaseSarcoidosisSyphilisTuberculosisOcular inflammation

Outcome Measures

Primary Outcomes (1)

  • Analysis of serum angiotensin converting enzyme level

    1 day

Secondary Outcomes (1)

  • Analysis of serum lysozyme level

    1 day

Study Arms (2)

serum angiotensin converting enzyme

ACTIVE COMPARATOR

spectrophotometric assay

Other: spectrophotometric assayOther: radial immunodiffusion

serum lysozyme

ACTIVE COMPARATOR

radial immunodiffusion

Other: spectrophotometric assayOther: radial immunodiffusion

Interventions

spectrophotometric assayOTHER

measurement of enzyme activity in the serum

serum angiotensin converting enzymeserum lysozyme
radial immunodiffusionOTHER

measurement of the precipitated ring diameters showing enzyme activity in the serum

serum angiotensin converting enzymeserum lysozyme

Eligibility Criteria

Age9 Years - 86 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DunyaGoz hospital Tunus caddesi no.28 kavaklidere

Çankaya, Ankara, 06450, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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.

    PMID: 21482866RESULT

  • Sen DK, Sarin GS. Immunoassay of serum muramidase (lysozyme) in ocular diseases. Indian J Ophthalmol. 1987;35(5-6):103-7.

    PMID: 3508756RESULT

  • 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.

    PMID: 26879979DERIVED

MeSH Terms

Conditions

SarcoidosisTuberculosisSpondylitis, AnkylosingBehcet SyndromeSyphilis

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsAxial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritisMouth DiseasesStomatognathic DiseasesUveitis, AnteriorPanuveitisUveitisUveal DiseasesEye DiseasesVasculitisVascular DiseasesCardiovascular DiseasesHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, VascularTreponemal InfectionsSpirochaetales InfectionsGram-Negative Bacterial InfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital Diseases

Study Officials

  • Ioannis Pallikaris, MD

    DunyaGoz Hospital, Etiler, yanarsu sokak no.1 besiktaş Istanbul Turkey

    STUDY CHAIR

Central Study Contacts

ozlem sahin, MD

CONTACT

90-537-5523064ozlem1158@yahoo.com

Eda Karaismailoglu, MS

CONTACT

90-533-3097848edaozturk@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor, Specialist in Ophthalmology, Uveitis and Ocular Immunology

Study Record Dates

First Submitted

November 26, 2015

First Posted

December 10, 2015

Study Start

June 1, 2014

Primary Completion

February 1, 2016

Study Completion

January 1, 2017

Last Updated

December 10, 2015

Record last verified: 2015-12

Locations

TU(1)