UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059922 |
|---|---|
| Receipt number | R000068533 |
| Scientific Title | Comprehensive Cataract Surgery Observational Database Study |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/11/29 07:59:45 |
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Basic information
Public title
Comprehensive Cataract Surgery Observational Database Study
Acronym
Comprehensive Cataract Surgery Observational Database Study
Scientific Title
Comprehensive Cataract Surgery Observational Database Study
Scientific Title:Acronym
Comprehensive Cataract Surgery Observational Database Study
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect perioperative data comprehensively and evaluate safety and minimally invasive characteristics.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in CECD; postoperative flare values
Key secondary outcomes
operative time, CDR, volume of fluid used, CV, HEX, PHC, complications
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
Patients with cataract
Key exclusion criteria
Ocular trauma, congenital cataracts, history of intraocular surgery, corneal opacity, etc.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Sato |
Organization
Sato Eye Clinic
Division name
Director
Zip code
271-0077
Address
Nemoto 3-3, Matsudo-shi 271-0077, Chiba-ken, Japan
TEL
0477029822
perfect-eightchop@sato-ganka.com
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Sato |
Organization
Sato Eye Clinic
Division name
Director
Zip code
2710077
Address
Nemoto 3-3, Matsudo-shi 271-0077, Chiba-ken, Japan
TEL
047-702-9822
Homepage URL
perfect-eightchop@sato-ganka.com
Sponsor or person
Institute
Sato Eye Clinic
Institute
Department
Personal name
Tsuyoshi Sato
Funding Source
Organization
Self-supply
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sato Eye Clinic
Address
Nemoto 3-3, Matsudo-shi 271-0077, Chiba-ken, Japan
Tel
0477029822
perfect-eightchop@sato-ganka.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 | 12 | 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
| 2025 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 11 | Month | 29 | Day |
Last modified on
| 2025 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068533
