UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056966 |
|---|---|
| Receipt number | R000065102 |
| Scientific Title | Effect of Contact Lens Wear History on Corneal Endothelial Cell Density After Implantable Collamer Lens (ICL) Implantation |
| Date of disclosure of the study information | 2025/02/07 |
| Last modified on | 2025/02/07 11:22:44 |
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Basic information
Public title
Effect of Contact Lens Wear History on Corneal Endothelial Cell Density After Implantable Collamer Lens (ICL) Implantation
Acronym
Effect of Contact Lens Wear History on Corneal Endothelial Cell Density After Implantable Collamer Lens (ICL) Implantation
Scientific Title
Effect of Contact Lens Wear History on Corneal Endothelial Cell Density After Implantable Collamer Lens (ICL) Implantation
Scientific Title:Acronym
Effect of Contact Lens Wear History on Corneal Endothelial Cell Density After Implantable Collamer Lens (ICL) Implantation
Region
| Japan |
Condition
Condition
Myopic Astigmatism
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the Effect of Contact Lens Wear History on Corneal Endothelial Cell Density After Implantable Collamer Lens (ICL) Implantation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Corneal Endothelial Cell Density
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases that underwent ICL surgery at Chukyo Eye Clinic between October 1, 2019, and December 1, 2024
Cases in which the surgery was completed following the standard procedure
Cases where information on contact lens wear history and duration was obtained through preoperative interviews or questionnaires
Key exclusion criteria
Cases with organic ocular diseases other than refractive error and dry eye (e.g., keratoconus, ocular inflammatory diseases, ocular infections, cataracts, glaucoma, retinal diseases) or a history of other ophthalmic surgeries
Cases deemed inappropriate by the principal investigator
Cases in which unforeseen circumstances occurred during surgery, resulting in deviation from the standard ICL surgical procedure
Cases requiring reoperation
Cases where information on contact lens (CL) wear history, type, material, and duration could not be obtained through preoperative interviews or questionnaires
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | satoshi |
| Middle name | |
| Last name | gotoda |
Organization
Chukyo eye clinic
Division name
Ophthalmology
Zip code
4560032
Address
12-22 Sanbonmatsu-cho, Atsuta-ku, Nagoya City, Aichi Prefecture
TEL
0528831543
sgotoda@chukyo-eyeclinic.jp
Public contact
Name of contact person
| 1st name | satoshi |
| Middle name | |
| Last name | gotoda |
Organization
Chukyo Eye Clinic
Division name
Ophthalmology
Zip code
456-0032
Address
12-22 Sanbonmatsu-cho, Atsuta-ku, Nagoya City, Aichi Prefecture
TEL
0528831543
Homepage URL
sgotoda@chukyo-eyeclinic.jp
Sponsor or person
Institute
Chukyo eye clinic
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chukyo Eye Clinic Ethics Review Committee
Address
12-22 Sanbonmatsu-cho, Atsuta-ku, Nagoya City, Aichi Prefecture
Tel
0528831543
snimi@chukyomedical.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
230
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 02 | Month | 07 | Day |
Last modified on
| 2025 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065102
