Status Approved
First Submitted Date
2020/11/16
Registered Date
2020/11/24
Last Updated Date
2020/11/16
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005621 |
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Unique Protocol ID | P01-202010-21-024 |
Public/Brief Title | Clinical results of Visian implantable collamer lens implantation according to various sizes and implantation angles |
Scientific Title | Relationship between postoperative vaulting and postoperative refractive error |
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 | P01-202010-21-024 |
Approval Date | 2020-10-19 |
Institutional Review Board Name | Public Internal Regulatory Board of the Ministry of Health and Welfare, Korea |
Institutional Review Board Address | #601, 53, Yulgok-ro, Jongno-gu, Seoul |
Institutional Review Board Telephone | 02-737-8995 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Bu Ki Kim |
Title | Dr. |
Telephone | +82-2-6913-0000 |
Affiliation | Onnuri Smile Ophthalmic Clinic |
Address | Hyobong Building 9F 1, Gangnam-daero 65 gil, Seocho-gu, Seoul, Korea |
Contact Person for Public Queries | |
Name | Bu Ki Kim |
Title | Dr. |
Telephone | +82-2-6913-0000 |
Affiliation | Onnuri Smile Ophthalmic Clinic |
Address | Hyobong Building 9F 1, Gangnam-daero 65 gil, Seocho-gu, Seoul, Korea |
Contact Person for Updating Information | |
Name | Bu Ki Kim |
Title | Dr. |
Telephone | +82-2-6913-0000 |
Affiliation | Onnuri Smile Ophthalmic Clinic |
Address | Hyobong Building 9F 1, Gangnam-daero 65 gil, Seocho-gu, Seoul, Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2020-10-20 Actual | |
Target Number of Participant | 300 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Onnuri Smile Ophthalmic Clinic | |
Recruitment Status | Completed | |
Date of First Enrollment | 2020-10-20 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Onnuri Smile Ophthalmic Clinic |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Onnuri Smile Ophthalmic Clinic |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Successful ICL implantation is related to ICL vault, defined as the distance between the anterior surface of the crystalline lens and the posterior surface of the ICL. Achieving an appropriate ICL vault is critical for preventing major postoperative adverse events.General consensus of ideal vault is 0.25 to 0.75 mm, however there are no exact criteria for surgical correction of the vault in the absence of vault-related complications, as there are also risks of repeated surgery such as corneal endothelial damage or astigmatic increase. So changing surgical plan of the fellow eye for achieving ideal vault according to the vault of first operated eye can be a good alternative method. But to our best knowledge, clinical outcomes about different size of ICL or different implantation angle of ICL on both eyes has not yet been reported. the aim of this study is to investigate effect of clinical outcomes when different size or different implantation angle of ICL was used for both eyes, and we also evaluated relationship between postoperative vault and refractive errors. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Case-control |
Time Perspective | Retrospective |
Target Number of Participant | 300 |
Cohort/Group Number | 3 |
Cohort/ Group 1 |
Cohort/Group Label Same sized-ICL implanted horizontally on both eyes |
Cohort/Group Description Same sized-ICL implanted horizontally on both eyes |
|
Cohort/ Group 2 |
Cohort/Group Label Different size of ICL implanted horizontally on both eyes |
Cohort/Group Description One size larger or smaller ICL was implanted horizontally, based on postoperative vault of initially operated eye. |
|
Cohort/ Group 3 |
Cohort/Group Label Same sized-ICL implanted with different implantation angle on both eyes |
Cohort/Group Description one eye - 90 degree, the other eye - 180 degree angle was used. |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Patients who visited our clinic for refractive surgery and the cornea is thin or has high refractive power before surgery |
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Sampling Method | convenience sampling |
Condition(s)/Problem(s) |
* (H00-H59)Diseases of the eye and adnexa (H52.1)Myopia Myopia |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~50Year |
|
Description corrected distance visual acuity ≥ 20/40, ACD > 2.8 mm, stable bilateral myopia for at least 1 years, refractive error in the correctable range (from -0.50 to -18.00 diopters), endothelial cell density ≥ 2,000 cells/mm2, and difference in horizontal WTW on both eye < 0.2 mm. |
|
Exclusion Criteria |
history of previous ocular surgery or trauma, uncontrolled systemic disease, corneal scarring or vascularization, and pregnancy |
Healthy Volunteers |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | Postoperative vault |
|
Timepoint | 1 day, 1 month, 3 months, 6 months, 12 months |
|
Secondary Outcome(s) 1 | ||
Outcome | Postoperative spherical equivalent |
|
Timepoint | 1 day, 1 month, 3 months, 6 months, 12 months |
|
Secondary Outcome(s) 2 | ||
Outcome | Postoperative intraocular pressure |
|
Timepoint | 1 day, 1 month, 3 months, 6 months, 12 months |
|
Secondary Outcome(s) 3 | ||
Outcome | Postoperative endothelial cell density |
|
Timepoint | 1 day, 1 month, 3 months, 6 months, 12 months |
|
Secondary Outcome(s) 4 | ||
Outcome | Postoperative uncorrected distance visual acuity |
|
Timepoint | 1 day, 1 month, 3 months, 6 months, 12 months |
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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