Status Approved
First Submitted Date
2017/11/28
Registered Date
2018/01/09
Last Updated Date
2017/12/20
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0002645 |
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Unique Protocol ID | DKUH 2017-02-005-002 |
Public/Brief Title | Short-term Effects and Safety of an acute increase of intraocular pressure on Corneal Endothelial Cells |
Scientific Title | Short-term Effects and Safety of an acute increase of intraocular pressure after Intravitreal Bevacizumab injection on Corneal Endothelial Cells |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | DKUH 2017-02-005-002 |
Approval Date | 2017-11-21 |
Institutional Review Board Name | Dankook University Hospital Institutional Review Board |
Institutional Review Board Address | |
Institutional Review Board Telephone | |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | MYUNGWON LEE |
Title | Clinical professor |
Telephone | +82-41-550-6490 |
Affiliation | Dankook Univeristy Hospital |
Address | 201, Manghang-Ro, Dongnam-Gu, Cheonan-City, Chungchungnam-Do, South Korea |
Contact Person for Public Queries | |
Name | JIWOONG PARK |
Title | Resident |
Telephone | +82-41-550-6490 |
Affiliation | Dankook Univeristy Hospital |
Address | 201, Manghang-Ro, Dongnam-Gu, Cheonan-City, Chungchungnam-Do, South Korea |
Contact Person for Updating Information | |
Name | JIWOONG PARK |
Title | Resident |
Telephone | +82-41-550-6490 |
Affiliation | Dankook Univeristy Hospital |
Address | 201, Manghang-Ro, Dongnam-Gu, Cheonan-City, Chungchungnam-Do, South Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2018-01-01 Anticipated | |
Target Number of Participant | 50 | |
Primary Completion Date | 2018-03-31 , Anticipated | |
Study Completion Date | 2018-05-31 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Dankook Univeristy Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2018-01-01 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Dankook Univeristy Hospital |
Organization Type | Medical Institute |
Project ID | DKUH 2017-02-005-002 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Dankook Univeristy Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Previous studies have shown that when an AACG attack occurs over 3 days, the endothelial CD significantly decreased. Considering this point, The purpose of this study is to evaluate short-term effects and safety of an acute increase of intraocular pressure (IOP) after single-dose intravitreal bevacizumab injection on corneal endothelial cells and central corneal thickness. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Case-only |
Time Perspective | Prospective |
Target Number of Participant | 50 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label Patients with macular edema or macular degeneration who are scheduled to undergo intravitreal bevacizumab injection |
Cohort/Group Description We will select patients who are scheduled to undergo intravitreal bevacizumab injection due to macula edema or macular degeneration. Before injection, patients underwent a complete ophthalmic examination including visual acuity tests with and without correction, slit-lamp examination, fundus examination, and optical coherence tomography (Cirrus HD-OCT®, version 5; Carl Zeiss Meditec, Dublin, CA, USA). Intraocular pressure and endothelial cell evaluations were performed before injection, and 2 minutes, 5 minutes, and 30 minutes after injection |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Among the patients who visit Dankook University Hospital, patients with macular edema or macular degeneration who are scheduled to undergo intravitreal bevacizumab injection |
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Sampling Method | Random selection |
Condition(s)/Problem(s) |
* (H00-H59)Diseases of the eye and adnexa (H35.39)Unspecified macular degeneration |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age No Limit~No Limit |
|
Description Patients with macular edema or macular degeneration who are scheduled to undergo intravitreal bevacizumab injection. Causes of macular edema: diabetic macular edema, retinal vein occlusion (center, branch), central serous choroidopathy, etc. |
|
Exclusion Criteria |
Patients were excluded if they had any ocular disease, previous any intravitreal injection, use of topical eyedrops for lowering IOP, or any ocular surgery history except cataract surgery that had no complication like phacoemulsification and posterior chamber lens implantation (PE&PCL). |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Intraocular pressure |
|
Timepoint | Before injection, and 2 minutes, 5 minutes, and 30 minutes after injection |
|
Primary Outcome(s) 2 | ||
Outcome | Central corneal thickness |
|
Timepoint | Before injection, and 2 minutes, 5 minutes, and 30 minutes after injection |
|
Primary Outcome(s) 3 | ||
Outcome | Corneal endothelial cell evaluations (coefficient of variation, hexagonality, cell density) |
|
Timepoint | Before injection, and 2 minutes, 5 minutes, and 30 minutes after injection |
|
Secondary Outcome(s) 1 | ||
Outcome | Ages, Surgical history (Cataract surgery), Presence or absence of diabetes |
|
Timepoint | Before injection |
11. Study Results and Publication
Result Registered |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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