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Evaluation of functional filtering bleb using optical coherence tomography Angiography

Status Approved

  • First Submitted Date

    2019/02/07

  • Registered Date

    2019/04/25

  • Last Updated Date

    2019/04/04

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003848
    Unique Protocol ID IRB No. 05-2017-089
    Public/Brief Title Evaluation of conjunctival vascularity after glaucoma surgery using optical coherence tomography Angiography
    Scientific Title Evaluation of functional filtering bleb using optical coherence tomography Angiography
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted exempt
    Board Approval Number 05-2017-089
    Approval Date 2017-07-05
    Institutional Review Board Name Yangsan Pusan National University Hospital Institutional Review Board
    Institutional Review Board Address 20, Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do
    Institutional Review Board Telephone 055-360-3854
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name JEHYUN SEO
    Title Research Doctor
    Telephone +82-2-2225-1445
    Affiliation VHS Medical Center
    Address 53 Jinhwangdo-ro 61 gil Gangdong-gu, Seoul 05368, Korea
    Contact Person for Public Queries
    Name JEHYUN SEO
    Title Research Doctor
    Telephone +82-2-2225-1445
    Affiliation VHS Medical Center
    Address 53 Jinhwangdo-ro 61 gil Gangdong-gu, Seoul 05368, Korea
    Contact Person for Updating Information
    Name JEHYUN SEO
    Title Research Doctor
    Telephone +82-2-2225-1445
    Affiliation VHS Medical Center
    Address 53 Jinhwangdo-ro 61 gil Gangdong-gu, Seoul 05368, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2017-07-06 Actual
    Target Number of Participant 95
    Primary Completion Date 2017-08-14 , Actual
    Study Completion Date 2017-12-31 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Pusan National University Yangsan Hospital
    Recruitment Status Completed
    Date of First Enrollment 2017-07-06 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Pusan National University Yangsan Hospital
    Organization Type Medical Institute
    Project ID L-2017-191
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Pusan National University Yangsan Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Purpose: To investigate whether filtering blebs can be evaluated using optical coherence tomography angiography (OCT-A), and to compare vascularity parameters with conventional bleb grading systems.
    Methods: A total of 92 patients with glaucoma, who underwent mitomycin-C-augmented trabeculectomy, were enrolled in this study and 92 eyes were assessed in total. The participants underwent OCT-A (Atlantis, Topcon) in external mode and anterior segment photography for bleb evaluation. For evaluation of bleb vascularity, a blinded observer carefully drew the bleb area on the original OCT-A image, using a semi-automated program, which calculated the color and brightness densities of the selected area. A blinded observer also classified the grades of the bleb vessels using the Indiana Bleb Appearance Grading Scale (IBAGS) and Moorfields Bleb Grading System (MBGS). The vascularity parameters using OCT-A were compared with the IBAGS and MBGS results. In addition, the correlation between intraocular pressure (IOP) and the bleb vascularity parameters was assessed.
    Results: Vessel density measured by OCT-A demonstrated excellent inter- and intra-observer reproducibility. The color and brightness densities were positively correlated with the IBAGS and MBGS vascularity scores. Neither the color and brightness densities (calculated using OCT-A) nor the IBAGS and MBGS vessel grading were associated with IOP. There was no difference in accuracy when predicting IOP risk using vascularity scores from the IBAGS and MBGS methods, or when estimating IOP risk using the new parameters—color and brightness densities—on net reclassification index, assuming an IOP cut-off value of 15 mmHg.
    Conclusions: Bleb evaluation using OCT-A can evaluate vessel vascularity and showed correlation to the IBAGS and MBGS vascularity grading.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-only
    Time Perspective Retrospective  
    Target Number of Participant 95
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Patients with glaucoma who underwent trabeculectomy for more than 6 months

    Cohort/Group Description

    The blood vessels densities were measured using optical coherence tomography Angiography, which is a noninvasive test for the density of blood vessels in the subconjunctival region of the trabeculectomy, and compared with the method of comparing the subject test images with the standard photographs.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Patients who underwent trabeculectomy with mitomycin as glaucoma in the ophthalmology department of Pusan ​​National University Hospital and observed for more than 6 months
    Sampling Method
    Patients in the study population were consecutively selected during the study period.
    Condition(s)/Problem(s) * (H00-H59)Diseases of the eye and adnexa 
       (H40.9)Glaucoma, unspecified 

    Patients who required surgical treatment with glaucoma Trabeculectomy with mitmycin C
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~No Limit

    Description

    Patients who underwent trabeculectomy with mitomycin as glaucoma in the ophthalmology department of Pusan ​​National University Hospital and observed for more than 6 months
    A person who was previously tested for glaucoma evaluation
    From December 2016 to August 2017, patients with conjunctival blood vessels were measured using optical coherence tomography Angiography
    The patients were diagnosed with primary glaucoma or pseudoexfoliation glaucoma, uveitic glaucoma, or steroid-induced glaucoma.
    
    Glaucoma surgery is not controlled by ophthalmic eye drops, is not effective on laser, and because of allergy, glaucoma eye drops can not be used.
    Exclusion Criteria
    Of the patients who were included in the study group, patients who did not have a record of optical coherence tomography angiography, patients who had low quality of optical coherence tomography, those who had glaucoma surgery, failed reoperation, or glaucoma eye drops were excluded.
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Vessel density (brightness density, color density)
    Timepoint
    When analyzing charts after IRB approval, the time of chart review with watching OCT-A images
    Secondary Outcome(s) 1
    Outcome
    Comparison of the Indiana Bleb Appearance Grading Scale (IBAGS) and the Moorfields Bleb Grading System (MBGS)
    Timepoint
    When analyzing charts after IRB approval, the time of chart review
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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