UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045609 |
|---|---|
| Receipt number | R000052073 |
| Scientific Title | Comparison of ocular biometry measurements using ANTERION, IOLMaster 700, and CASIA2 |
| Date of disclosure of the study information | 2021/09/30 |
| Last modified on | 2022/04/01 09:21:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of ocular biometry measurements using ANTERION, IOLMaster 700, and CASIA2
Acronym
Comparison of ocular biometry measurements using ANTERION, IOLMaster 700, and CASIA2
Scientific Title
Comparison of ocular biometry measurements using ANTERION, IOLMaster 700, and CASIA2
Scientific Title:Acronym
Comparison of ocular biometry measurements using ANTERION, IOLMaster 700, and CASIA2
Region
| Japan |
Condition
Condition
Patients before cataract surgery and patients before refraction correction
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Anterion, IOLMaster 700, and CASIA2 are measured for patients undergoing pre-cataract and pre-refraction surgery tests, and biometric values are compared.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
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, corneal diameter
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients before cataract surgery and patients before refraction correction
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
200
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
2520375
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL
0427788111
kamiyak-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Rina |
| Middle name | |
| Last name | Ogawa |
Organization
Kitasato university Hospital
Division name
Ophthalmology
Zip code
2520375
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL
0427788429
Homepage URL
rina-o@umin.ac.jp
Sponsor or person
Institute
Kitasato university Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitasato university 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
Kitasato University Hospital
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
Tel
0427788111
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
北里大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 30 | 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
200
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
| 2021 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The average corneal refractive power, corneal astigmatism, corneal thickness, axial length, anterior chamber depth, lens thickness, and corneal diameter are measured and compared between models.
Management information
Registered date
| 2021 | Year | 09 | Month | 30 | Day |
Last modified on
| 2022 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052073
