UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045082 |
|---|---|
| Receipt number | R000051484 |
| Scientific Title | Examination of astigmatism correction effect and visual function / satisfaction of toric phakic intraocular lens using preoperative and intraoperative image guide system |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2023/03/31 14:24:37 |
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Basic information
Public title
Examination of astigmatism correction effect and visual function / satisfaction of toric phakic intraocular lens using preoperative and intraoperative image guide system
Acronym
Examination of astigmatism correction effect and visual function / satisfaction of toric phakic intraocular lens using preoperative and intraoperative image guide system
Scientific Title
Examination of astigmatism correction effect and visual function / satisfaction of toric phakic intraocular lens using preoperative and intraoperative image guide system
Scientific Title:Acronym
Examination of astigmatism correction effect and visual function / satisfaction of toric phakic intraocular lens using preoperative and intraoperative image guide system
Region
| Japan |
Condition
Condition
myopic astigmatism
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The subjects are patients undergoing toric phakic intraocular lens (Visian ICL, STAAR Surgical) surgery at Kitasato University Hospital and Miyata Eye Hospital. Comparing visual acuity, refraction, astigmatism correction effect by vector analysis by Holladay-Cravy-Koch method, pain / satisfaction between two groups of preoperative and intraoperative image guide system (VERION, Alcon) and manual marking.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Astigmatism axis shift amount
Key secondary outcomes
Uncorrected / Corrected Visual Acuity (logMAR)
Refractive power (spherical equivalent / astigmatic power)
corneal astigmatism
Astigmatism correction effect (Correction Index = achieved astigmatism correction power / target astigmatism correction power)
Double angle plots
Caused astigmatism (mean, median, center of gravity)
Pain during marking / surgery (VAS)
Overall Surgery Satisfaction (VAS)
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
At Kitasato University Hospital and Miyata Eye Hospital, patients who wish to have toric phakic intraocular lens surgery for moderate / severe myopia during the period from the approval date of the long research period to March 31, 2023.
Cases between the ages of 20 and 50
Cases of corneal astigmatism 1.25D or more
Distance correction Cases in which it can be predicted that visual acuity will be corrected to 1.0 or higher in both eyes.
Key exclusion criteria
Cases with a history of organic eye diseases other than refractive error (keratoconus, dry eye, eye inflammation disease, eye infection, cataract, glaucoma, retinal disease, etc.) and other eye surgery
Cases in which the reliability of biometric data obtained by preoperative examination is low
Cases judged by the principal investigator to be inappropriate
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kazutaka |
| Middle name | |
| Last name | Kamiya |
Organization
Kitasato university hospital
Division name
Ophthalmology
Zip code
252-0375
Address
1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa Prefecture
TEL
042-778-8464
ads00133@gmail.com
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Gotoda |
Organization
Kitasato university hospital
Division name
Ophthalmology
Zip code
252-0375
Address
1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa Prefecture
TEL
09055477361
Homepage URL
snothingventurednothinggained@gmail.com
Sponsor or person
Institute
Kitasato university
Institute
Department
Personal name
Funding Source
Organization
Japan Alcon Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasatouniversityhospital
Address
1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa Prefecture
Tel
0427788464
rinri@med.kitasato-u.ac.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
| 2021 | Year | 09 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
While the research is ongoing, the progress of the research will be reported in writing to the director of the research institution every year from the date of approval of the research by the Institutional Review Board. In addition, when the research is completed, the completion will be reported to the director of the research institution immediately.
Management information
Registered date
| 2021 | Year | 08 | Month | 06 | Day |
Last modified on
| 2023 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051484
