UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051095 |
|---|---|
| Receipt number | R000058269 |
| Scientific Title | Evaluation of accuracy of axial length measurements and repeatability between ARGOS and ANTERION in cataract patients. |
| Date of disclosure of the study information | 2023/05/18 |
| Last modified on | 2023/05/18 12:30:45 |
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Basic information
Public title
Comparison of Accuracy of Axial Length Measurement and Repeatability between ARGOS and ANTERION, Preoperative Cataract Examination Devices
Acronym
Comparison of Accuracy and Repeatability of Axial Length Measurement Devices
Scientific Title
Evaluation of accuracy of axial length measurements and repeatability between ARGOS and ANTERION in cataract patients.
Scientific Title:Acronym
Evaluation of accuracy of axial length measurement and repeatability in SS-OCT biometers
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the accuracy of AL measurement between ARGOS and ANTERION before and after surgery.
Also, to evaluate the repeatability of multiple sets of measurements within the examiner and the agreement of measurements.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Axial length change from pre-operative to post-operative
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients with the age of over 50 and under 90
2.Patients with nuclear hardness 1-4 (Emery-little classification)
3.Patients with AL measured on both ARGOS and ANTERION
4.Patients with preoperative corneal astigmatism <3.0D
Key exclusion criteria
1.Patients with ocular diseases that may affect fixation or imaging quality, such as severe dry eye, corneal opacity, and maculopathy
2.Patients with the history of any ocular surgery like LASIK
3.Patients who cannot obtain images with ARGOS or ANTERION due to poor fixation
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Ichikawa |
Organization
Chukyo Eye Clinic
Division name
Chukyo Eye Clinic
Zip code
456-0032
Address
12-22, Sanbonmatsu-cho, Atsuta-ku, Nagoya, Aichi, JAPAN
TEL
052-883-1543
ichikawa@chukyogroup.jp
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Ichikawa |
Organization
Chukyo Eye Clinic
Division name
Chukyo Eye Clinic
Zip code
456-0032
Address
12-22, Sanbonmatsu-cho, Atsuta-ku, Nagoya, Aichi, JAPAN
TEL
052-883-1543
Homepage URL
ichikawa@chukyogroup.jp
Sponsor or person
Institute
Chukyo Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Alcon Japan 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
REC, Chukyo Eye Clinic
Address
12-22, Sanbonmatsu-cho, Atsuta-ku, Nagoya, Aichi, JAPAN
Tel
052-884-7976
rec@chukyogroup.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 | 05 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To compare the accuracy of AL measurement between ARGOS and ANTERION before and after surgery.
Also, to evaluate the repeatability of multiple sets of measurements within the examiner and the agreement of measurements.
Management information
Registered date
| 2023 | Year | 05 | Month | 18 | Day |
Last modified on
| 2023 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058269
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
