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
CRIS Registration Number |
KCT0003848 |
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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
Board Approval Status | Submitted exempt |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Pusan National University Yangsan Hospital |
Organization Type | Medical Institute |
Project ID | L-2017-191 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Pusan National University Yangsan Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Observational Study |
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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. |
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Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
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 |
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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. |
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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)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Vessel density (brightness density, color density) |
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Timepoint | When analyzing charts after IRB approval, the time of chart review with watching OCT-A images |
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Secondary Outcome(s) 1 | ||
Outcome | Comparison of the Indiana Bleb Appearance Grading Scale (IBAGS) and the Moorfields Bleb Grading System (MBGS) |
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Timepoint | When analyzing charts after IRB approval, the time of chart review |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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