UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040893 |
|---|---|
| Receipt number | R000046617 |
| Scientific Title | Prospective multicenter study corneal endothelial cell loss in cataract surgery with pseudoexfoliation syndrome |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2020/12/28 10:47:08 |
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Basic information
Public title
Prospective multicenter study corneal endothelial cell loss in cataract surgery with pseudoexfoliation syndrome
Acronym
Investigation of Corneal endothelial damage in pseudoexfoliation syndrome
Scientific Title
Prospective multicenter study corneal endothelial cell loss in cataract surgery with pseudoexfoliation syndrome
Scientific Title:Acronym
Investigation of Corneal endothelial damage in pseudoexfoliation syndrome
Region
| Japan |
Condition
Condition
Pseudoexfoliation syndrome
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine corneal endothelial cell damage post cataract surgery in Pseudoexfoliation syndrome patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The percentage of corneal endothelial cells loss post cataract surgery
Key secondary outcomes
Central corneal thickness post cataract surgery, cytokine in hydatoid and risk factor of corneal endothelial cell loss
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
| 55 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with pseudoexfoliation syndrome and patients with no pseudoexfoliation materials has age-related cataract.
Key exclusion criteria
no history except cataract and open-angle glaucoma, no history of laser and intraocular surgery, no history of Trauma to eyes
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Kitazawa |
Organization
Kyoto Prefectural University of Medicine
Division name
Ophthalmology
Zip code
602-0841
Address
465, Kajiicho, Kamigyo-ku, Kyoto-City
TEL
075-251-5578
kkitazaw@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Aoki |
Organization
Kyoto Prefectural University of Medicine
Division name
Ophthalmology
Zip code
602-0841
Address
465, Kajiicho, Kamigyo-ku, Kyoto-City
TEL
075-251-5578
Homepage URL
taka526@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
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
Independent Ethics Committee, Kyoto Prefectural University of Medicine
Address
465, Kajiicho, Kamigyo-ku, Kyoto-City
Tel
075-251-5210
rinri@koto.kpu-m.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 | 07 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 06 | Month | 25 | Day |
Last modified on
| 2020 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046617
