UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039976 |
|---|---|
| Receipt number | R000045580 |
| Scientific Title | Comparison of Preoperative Biometry for Cataract Surgery among Major Domestic Institutions. |
| Date of disclosure of the study information | 2020/03/29 |
| Last modified on | 2023/10/01 11:21:00 |
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Basic information
Public title
Comparison of Preoperative Biometry for Cataract Surgery among Major Domestic Institutions.
Acronym
Comparison of Preoperative Biometry for Cataract Surgery among Major Domestic Institutions.
Scientific Title
Comparison of Preoperative Biometry for Cataract Surgery among Major Domestic Institutions.
Scientific Title:Acronym
Comparison of Preoperative Biometry for Cataract Surgery among Major Domestic Institutions.
Region
| Japan |
Condition
Condition
Patients before cataract surgery
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the preoperative biometric data of cataract surgery among the major domestic institutions.
Basic objectives2
Others
Basic objectives -Others
Comparison
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
keratometry, corneal astigmatism, corneal thickness, axial length, anterior chamber depth, corneal thickness, and lens thickness.
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
| 21 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients before cataract surgery with scans of the optical biometer.
Key exclusion criteria
Eyes with any history of ocular surgery, ocular trauma, or other concomitant eye diseases, and eyes developing any intraoperative or postoperative complications
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Kazutaka |
| Middle name | |
| Last name | Kamiya |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
2520373
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL
0427788464
kamiyak-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kazutaka |
| Middle name | |
| Last name | Kamiya |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
2520373
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL
0427788464
Homepage URL
kamiyak-tky@umin.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
Tel
0427788464
kamiyak-tky@umin.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
| 2020 | Year | 03 | Month | 29 | Day |
Related information
URL releasing protocol
Br J Ophthalmol. 2022 Sep;106(9):1227-1234. doi: 10.1136/bjophthalmol-2021-318825.
Publication of results
Published
Result
URL related to results and publications
Br J Ophthalmol. 2022 Sep;106(9):1227-1234. doi: 10.1136/bjophthalmol-2021-318825.
Number of participants that the trial has enrolled
2143
Results
Regional divergences of the preoperative biometry were not necessarily negligible, and the optimized IOL power calculation formula was individually different among the 12 facilities. Our findings highlight the importance of individual optimization of these formulas at each facility, especially in consideration of these biometric variations.
Results date posted
| 2023 | Year | 10 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients undergoing standard cataract surgery at major 12 facilities
Participant flow
Informed consent was abtained.
Adverse events
None
Outcome measures
Preoperative biometry
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To compare the preoperative biometric data of cataract surgery among the major domestic institutions.
Management information
Registered date
| 2020 | Year | 03 | Month | 29 | Day |
Last modified on
| 2023 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045580
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
