UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056423 |
|---|---|
| Receipt number | R000064470 |
| Scientific Title | Clinical outcomes of phakic intraocular lens implantation for hyperopic astigmatism |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2024/12/11 00:34:00 |
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Basic information
Public title
Clinical results of ICL surgery for hyperopia
Acronym
Clinical Results of Hyperopic ICL
Scientific Title
Clinical outcomes of phakic intraocular lens implantation for hyperopic astigmatism
Scientific Title:Acronym
Clinical outcomes of phakic intraocular lens implantation for hyperopia
Region
| Japan |
Condition
Condition
hyperopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety, efficacy, stability, and accuracy of refractive surgery using ICL for hyperopic astigmatism
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety, effectiveness, stability, and correction accuracy one month after surgery
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older who underwent ICL surgery for hyperopia or hyperopic astigmatism were able to be followed up for one month after surgery
Key exclusion criteria
Concomitant organic disease, unable to give consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masahide |
| Middle name | |
| Last name | Takahashi |
Organization
Sanno Hospital
Division name
Ophthalmology
Zip code
107-0052
Address
8-10-16 Akasaka, Minato-ku, Tokyo
TEL
0334023151
zavide96@gmail.com
Public contact
Name of contact person
| 1st name | Masahide |
| Middle name | |
| Last name | Takahashi |
Organization
Sanno Hospital
Division name
Ophthalmology
Zip code
107-0052
Address
8-10-16 Akasaka, Minato-ku, Tokyo
TEL
0334023141
Homepage URL
zavide96@gmail.com
Sponsor or person
Institute
Sanno Hospital
Institute
Department
Personal name
Funding Source
Organization
Sanno Hospital
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
Junwakai IRB
Address
8-10-16 Akasaka, Minato-ku, Tokyo
Tel
0334023151
zavide96@gmail.com
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 | 01 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will retrospectively examine, based on past medical records, the clinical outcomes of patients who underwent ICL implantation surgery for hyperopia or hyperopic astigmatism at our hospital and were able to be followed up for one month after surgery, at preoperative, 1 week, 1 month, 3 months, 12 months after surgery, and at the final follow-up thereafter.
Management information
Registered date
| 2024 | Year | 12 | Month | 11 | Day |
Last modified on
| 2024 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064470
