Status Approved
First Submitted Date
2021/03/09
Registered Date
2021/03/12
Last Updated Date
2021/03/09
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0005995 |
|---|---|
| Unique Protocol ID | P01-201805-13-001 |
| Public/Brief Title | Effect of Blue-light Blocking Ophthalmic Lenses on the Tear film Stability and Subjective symptoms when Working with a Smartpad |
| Scientific Title | Effect of Blue-light Blocking Ophthalmic Lenses on the Tear film Stability and Subjective symptoms when Working with a Smartpad |
| 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 |
|---|---|
| Board Approval Number | P01-201805-13-001 |
| Approval Date | 2018-05-07 |
| Institutional Review Board Name | KONIBP Institutional Review Board |
| Institutional Review Board Address | 113, Namdaemun-ro, Jung-gu, Seoul, 04522, Republic of Korea |
| Institutional Review Board Telephone | 02-737-8490 |
| Data Monitoring Committee |
Yes
KONIBP Institutional Review Board |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | So Ra Kim |
| Title | professor |
| Telephone | +82-2-970-6225 |
| Affiliation | Seoul National University of Science and Technology |
| Address | 232, Gongneung-ro, Nowon-gu, Seoul, Republic of Korea |
| Contact Person for Public Queries | |
| Name | Hyun Jin Kim |
| Title | student |
| Telephone | +82-2-970-6225 |
| Affiliation | Seoul National University of Science and Technology |
| Address | 232, Gongneung-ro, Nowon-gu, Seoul, Republic of Korea |
| Contact Person for Updating Information | |
| Name | Hyun Jin Kim |
| Title | student |
| Telephone | +82-2-970-6225 |
| Affiliation | Seoul National University of Science and Technology |
| Address | 232, Gongneung-ro, Nowon-gu, Seoul, Republic of Korea |
4. Status
| Study Site | Single | |
|---|---|---|
| Overall Recruitment Status | Completed | |
| Date of First Enrollment | 2018-05-10 Actual | |
| Target Number of Participant | 30 | |
| Primary Completion Date | 2018-12-31 , Actual | |
| Study Completion Date | 2019-12-31 , Actual | |
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | Seoul National University of Science and Technology | |
| Recruitment Status | Completed | |
| Date of First Enrollment | 2018-05-10 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | Seoul National University of Science and Technology |
| Organization Type | University |
| Project ID | |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | Seoul National University of Science and Technology |
| Organization Type | University |
7. Study Summary
| Lay Summary | LED lights are frequently used in displays of computers and smart devices, and LED lights have high emission at a blue wavelength (400-490 nm) in the visible region and may cause photochemical damage to visual functions. When using a smart device, digital eye fatigue is induced, and excessive exposure to blue light may lead to oxidative damage to the cornea, increased inflammation on the surface of the eye, and dry eye syndrome. The blue-blocking glasses lenses are used for the purpose of reducing the fatigue of the eyes by partially blocking these blue-light areas. In this study, the effects of the blue light blocking lens on the tear film stability and the amount of tears and the amount of tears in the near field through smart pads in normal and dry eyes, considering that the blue light blocking lens also affects the tear film stability. We want to see the correlation by measuring the number of blink rate, and we want to determine readability by measuring reading speed and questioning subjective symptoms. |
|---|
8. Study Design
| Study Type | Observational Study |
|---|---|
| Observational Study Model | Case-control |
| Time Perspective | Cross-sectional |
| Target Number of Participant | 30 |
| Cohort/Group Number | 2 |
|
Cohort/ Group 1 |
Cohort/Group Label Normal eyes |
|
Cohort/Group Description The subjects were further divided according to their non-invasive tear break-up time (NIBUT) of both eyes : normal-eyes group (≥ 10 seconds) |
|
|
Cohort/ Group 2 |
Cohort/Group Label Dry eyes |
|
Cohort/Group Description The subjects were further divided according to their non-invasive tear break-up time (NIBUT) of both eyes : dry-eyes group (< 10 seconds) |
|
| Biospecimen Collection & Archiving |
Not collect nor Archive |
| Biospecimen Description |
9. Subject Eligibility
| Study Population Description | Healthy adults in their 20s among South Korean residents |
|---|---|
| Sampling Method | simple random sampling |
| Condition(s)/Problem(s) |
* (H00-H59)Diseases of the eye and adnexa (H04.11)Dry eye syndrome Normal eyes or dry eyes |
| Rare Disease | No |
| Inclusion Criteria |
Gender Both |
|
Age 19Year~29Year |
|
|
Description Healthy volunteers aged between 19 and 29 years |
|
| Exclusion Criteria |
vulnerable class, systemic disease, except for dry eyes, none of the subjects had an ocular disease, history of ocular surgery, or binocular vision anomaly |
| Healthy Volunteers | Yes |
10. Outcome Measure(s)
| Type of Primary Outcome | clinical-equivalence | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | The effect of blue-blocking eyeglass lenses compared to general control eyeglass lenses |
|
| Timepoint | Analysis of results after the end of the experiment |
|
| Secondary Outcome(s) 1 | ||
| Outcome | Effects of blue-blocking eyeglass lenses in normal and dry eyes |
|
| Timepoint | Analysis of results after the end of the experiment |
|
11. Study Results and Publication
| Result Registered | No |
|---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | No |
|---|
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