Status Approved
First Submitted Date
2018/05/31
Registered Date
2019/04/11
Last Updated Date
2019/04/01
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0003743 |
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Unique Protocol ID | KYUH 2017-12-012 |
Public/Brief Title | A Study on Healthy Eye Reference Database of Koreans using Spectral Domain OCT.(Prospective, Single Institution, Public, Intervention, Single Group) |
Scientific Title | A Study on Healthy Eye Reference Database of Koreans using Spectral Domain OCT.(Prospective, Single Institution, Public, Intervention, Single Group) |
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 approval |
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Board Approval Number | KYUH 2017-12-012-001 |
Approval Date | 2018-02-06 |
Institutional Review Board Name | KONYANG UNIV.HOSPITAL IRB |
Institutional Review Board Address | 158, Gwanjeodong-ro, Seo-gu, Daejeon |
Institutional Review Board Telephone | 042-600-9057 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | JEONG JAE HOON |
Title | MD,PhD |
Telephone | +82-42-600-9250 |
Affiliation | Konyang University Hospital |
Address | 158, Gwanjeodong-ro, Seo-gu, Daejeon, Republic of Korea |
Contact Person for Public Queries | |
Name | JEONG JAE HOON |
Title | MD,PhD |
Telephone | +82-42-600-9250 |
Affiliation | Konyang University Hospital |
Address | 158, Gwanjeodong-ro, Seo-gu, Daejeon, Republic of Korea |
Contact Person for Updating Information | |
Name | LEE CHANG SOO |
Title | QM Manager |
Telephone | +82-31-428-9151 |
Affiliation | Huvitz |
Address | 38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 14055, Republic of Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2018-03-07 Actual | |
Target Number of Participant | 200 | |
Primary Completion Date | 2018-10-19 , Actual | |
Study Completion Date | 2019-04-30 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Konyang University Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2018-03-07 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Huvitz |
Organization Type | Others |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Huvitz |
Organization Type | Others |
7. Study Summary
Lay Summary | OCT(Optical Coherence Tomography) is known as an effective device that provides necessary information to detect Glaucoma and Retinal disease in early phase. And OCT Reference Database collected in healthy eyes should be established to suggest in which level the patient’s results are compared to the normal eyes. In this study, establish the reference database of 300 health eyes after pre-defined screening test. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Others (Data gathering) |
Phase | Not applicable |
Intervention Model | Single Group |
Blinding/Masking | Open |
Allocation | Not Applicable |
Intervention Type | Medical Device |
Intervention Description | according to the pre-defined screenning test, measure the healthy eye 3times. |
Number of Arms | 1 |
Arm 1 |
Arm Label Healthy eye |
Target Number of Participant 200 |
|
Arm Type Experimental |
|
Arm Description 1. average, superior, inferior, terporal and nasal thickness of retinal nerve fiber layer. 2. thickness of O'clock hour segement in retinal nerve fiber layer. 3. thickness of central fovea, inner macular and outer macular. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (H00-H59)Diseases of the eye and adnexa (H40.9)Glaucoma, unspecified healthy eye. |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 20Year~70Year |
|
Description 1. Age range between more than 20 ~ less than 70 years old. 2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent 3. No ocular medication (except artificial tears/moistening drops) necessary 4. Eyes with spherical power <= ±4.0D, cylindrical power <= ±3.0D 5. Corrected distance visual acuity - ≥ 1.0 [20/20] for subjects up to 60 years; - ≥ 0.8 [20/25] for subjects from 61 to 70 years; 6. Intraocular pressure <= 21 mmHg 7. Normal anterior segments, i.e. no clinically-relevant abnormalities -. Eyes with no closed iridocorneal angle structure 8. Ocular fundus: normal appearance, i.e. no clinically-relevant abnormalities (examination with undilated pupils) 9. Eyes without prior intraocular surgery (except cataract surgery) without clinically-relevant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve. 10. Eyes without a history of corneal refractive surgery. |
|
Exclusion Criteria |
1. Amblyopia 2. Relevant opacities of the central refractive media (cornea, lens, vitreous body) 3.Drugs indicating severe general diseases (anti-diabetic pharmaceuticals and anti-hypertensive medication are allowed for subjects older than 70 years) 4. Eyes having experience wearing hard contact(RGB) lenses within 2 weeks from the screening date 5. Pregnant or lactating women 6. One who can influence the study results by ethically or else, accordingly considered to be ineligible |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | Pearson correlation coefficient between age and thickness, RNFL thickness with segmentation. |
|
Timepoint | same time |
|
Secondary Outcome(s) 1 | ||
Outcome | O’clock hour segment thickness of RNFL |
|
Timepoint | same time |
|
Secondary Outcome(s) 2 | ||
Outcome | Macular thickness |
|
Timepoint | same time |
|
Secondary Outcome(s) 3 | ||
Outcome | Optic nerve head parameter area or ratio |
|
Timepoint | same time |
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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