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Analysis of changes in images of optical coherence tomography and optical coherence tomographic angiography after laser photocoagulation in retinal vascular disease.

Status Approved

First Submitted Date

2020/08/26
Registered Date

2020/10/15
Last Updated Date

2020/10/09

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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	KCT0005498
Unique Protocol ID	2019AN0173
Public/Brief Title	Analysis of changes in images of optical coherence tomography and optical coherence tomographic angiography after laser photocoagulation in retinal vascular disease.
Scientific Title	Analysis of changes in images of optical coherence tomography and optical coherence tomographic angiography after laser photocoagulation in retinal vascular disease.
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 approval
Board Approval Number	2019AN0173
Approval Date	2019-05-13
Institutional Review Board Name	Korea University Anam Hospital Institutional Review Board
Institutional Review Board Address	73, Inchon-ro, Seongbuk-gu, Seoul
Institutional Review Board Telephone	02-920-6566
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	Jaeryung Oh
Title	Professor
Telephone	+82-2-920-5399
Affiliation	Korea University Anam Hospital
Address	73, Inchon-ro, Seongbuk-gu, Seoul
Contact Person for Public Queries
Name	Cheolmin Yun
Title	Associate professor
Telephone	+82-31-412-4812
Affiliation	Korea University
Address	123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Republic of Korea
Contact Person for Updating Information
Name	Cheolmin Yun
Title	Associate professor
Telephone	+82-31-412-4812
Affiliation	Korea University
Address	123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Republic of 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
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 4
Overall Recruitment Status	Active, not recruiting
Date of First Enrollment	2019-05-27 Actual
Target Number of Participant	20
Primary Completion Date	2020-03-19 , Actual
Study Completion Date	2021-03-30 , Anticipated
Name of Study	Koera University Guro Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2020-10-12 ,
Recruitment Status by Participating Study Site 2
Name of Study	Korea University Ansan Hospital
Recruitment Status	Active, not recruiting
Date of First Enrollment	2019-05-27 ,
Recruitment Status by Participating Study Site 3
Name of Study	Gachon University, Donginchoen Gil Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2020-10-12 ,
Recruitment Status by Participating Study Site 4
Name of Study	Korea University Anam Hospital
Recruitment Status	Active, not recruiting
Date of First Enrollment	2019-06-13 ,

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	Ministry of Trade, Industry & Energy
Organization Type	Government
Project ID	10063364

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Korea University Anam Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Retinal laser photocoagulation is a treatment option for the retinal vascular disease with macular edema. The target lesion was confirmed with fundus examination or invasive fluorescein angiography. Recently, with the development of the imaging technique, optical coherence tomography angiography provides retinal vascular image without injection of dye. Therefore, we can obtain the characteristics of the lesion rapidly and noninvasive. In this study, we will obtain the pre- and post- treatment optical coherence tomography and its angiography images and investigate the occlusion of microaneurysm, changes in retinal thickness and visual acuity.

Study Summary Information

Lay Summary

Retinal laser photocoagulation is a treatment option for the retinal vascular disease with macular edema. The target lesion was confirmed with fundus examination or invasive fluorescein angiography. Recently, with the development of the imaging technique, optical coherence tomography angiography provides retinal vascular image without injection of dye. Therefore, we can obtain the characteristics of the lesion rapidly and noninvasive. In this study, we will obtain the pre- and post- treatment optical coherence tomography and its angiography images and investigate the occlusion of microaneurysm, changes in retinal thickness and visual acuity.

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	Prospective
Target Number of Participant	20
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Men and women between the ages of 20 and 80 who have been diagnosed with retinal vascular disease (diabetic retinopathy, retinal vascular obstruction) by ophthalmic examination and have macular edema
Cohort/ Group 1	Cohort/Group Description This study includes patients undergoing retinal laser photocoagulation, which is a common ophthalmic treatment method, due to diabetic retinopathy or retinal vein obstruction with macular edema. This study will analyze the imaging data (Autofluorescence image, Optical coherence tomography image, Optical coherence tomography angiography image) during the study period (before treatment, 2 months and 4 months after the treatment).
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Patients (male of female) aged between 20 to 80 who visit the hospital
Sampling Method	convenience sampling
Condition(s)/Problem(s)	* (H00-H59)Diseases of the eye and adnexa (H34.8)Other retinal vascular occlusions Diabetic macular edema Retinal vein occulsion
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~80Year
	Description 1. Diabetic retinopathy with macular edema 2. Retinal vein occlusion with macular edema
Exclusion Criteria	1. Corneal abnormality 2. Severe cataract 3. Vitreous opacity or hemorrhage 4. Poor cooperation to capture the image or treatment 5. History of a previous macular laser treatment 6. Any other conditions who cannot be enrolled by the judgement of the PI
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	Occlusion of microaneurysm
Timepoint	2months and 4months after treatment
Secondary Outcome(s) 1
Outcome	Changes in retinal thickness
Timepoint	2months and 4months after treatment
Secondary Outcome(s) 2
Outcome	Changes in visual acuity
Timepoint	2months and 4months after treatment

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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