UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052884 |
|---|---|
| Receipt number | R000059293 |
| Scientific Title | Clinical outcome of vertical fixation of Implantable Collamer Lens; within-subjects |
| Date of disclosure of the study information | 2023/11/24 |
| Last modified on | 2024/05/12 10:30:17 |
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Basic information
Public title
Clinical outcome of vertical fixation of Implantable Collamer Lens; within-subjects
Acronym
Clinical outcome of vertical fixation of Implantable Collamer Lens; within-subjects
Scientific Title
Clinical outcome of vertical fixation of Implantable Collamer Lens; within-subjects
Scientific Title:Acronym
Clinical outcome of vertical fixation of Implantable Collamer Lens; within-subjects
Region
| Japan |
Condition
Condition
Myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the postoperative results and fixation status of implantable collamer lens in a vertical orientation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative refraction, anterior chamber depth, and intraocular lens-to-lens distance (vault) will be measured and compared between vertical and horizontal fixation. The differences from the predictions of the N-K and K-S formulas for each fixation method will also be compared 3 months postoperatively.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
ICL transplantation with horizontal fixation
Interventions/Control_2
ICL Implantation with Vertical Fixation
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
| 21 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Myopia greater than 3D or myopic astigmatism
Key exclusion criteria
The patient has an ocular disease other than refractive error.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Ouchi |
Organization
Masayuki Ouchi Eye Clinic
Division name
Ophthalmology
Zip code
6018449
Address
9 Nishikujo Ohkuni-cho Minami-ku, Kyoto, Japan
TEL
09077560248
mouchi@skyblue.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Ouchi |
Organization
Masayuki Ouchi Eye Clinic
Division name
Ophthalmology
Zip code
6018449
Address
9 Nishikujo Ohkuni-cho Minami-ku, Kyoto, Japan
TEL
09077560248
Homepage URL
http://www.ouchi-eye.com
mouchi@skyblue.ocn.ne.jp
Sponsor or person
Institute
Masayuki Ouchi Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Masayuki Ouchi Eye clinic
Address
9 Nishikujo Ohkuni-cho Minami-ku, Kyoto, Japan
Tel
0756625660
mouchi@skyblue.ocn.ne.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
| 2023 | Year | 11 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
63
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
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 23 | Day |
Last modified on
| 2024 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059293
