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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040893
Receipt No. R000046617
Scientific Title Prospectice multicenter study on prognosis and treatment for patients with pseudoexfoliation syndrome
Date of disclosure of the study information 2020/07/01
Last modified on 2020/06/25

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Basic information
Public title Prospectice multicenter study on prognosis and treatment for patients with pseudoexfoliation syndrome
Acronym Investigation of Corneal endothelial damage in pseudoexfoliation syndrome
Scientific Title Prospectice multicenter study on prognosis and treatment for patients 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
Email 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
Email taka526@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
Email 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 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046617

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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