UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037627 |
|---|---|
| Receipt number | R000042421 |
| Scientific Title | Disease registry of glaucoma patients |
| Date of disclosure of the study information | 2019/08/09 |
| Last modified on | 2021/06/18 14:15:47 |
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Basic information
Public title
Disease registry of glaucoma patients
Acronym
Disease registry of glaucoma patients
Scientific Title
Disease registry of glaucoma patients
Scientific Title:Acronym
Disease registry of glaucoma patients
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish a disease registry of Japanese glaucoma patients to allow prospective evaluation and long-term observation, and obtain data for use in clinical trials to develop novel therapeutic agents
Basic objectives2
Others
Basic objectives -Others
Progression of visual field loss (MD slope)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression of visual field loss (MD slope)
Key secondary outcomes
Vision (highest corrected vision)
Intraocular pressure
height, weight
Pulse rate, blood pressure (systolic and diastolic blood pressure)
Fundus examination
Stereo fundus examination (optical nerve head parameter)
Visual field (MD value, upper half visual field TD value, lower half visual field TD value, foveal threshold, MD slope)
Laser speckle fundus blood flow meter (optical nerve head tissue blood flow)
Optical coherence tomography (cpRNFLT, mRNFL, mIPL + GCL, mGCC)
Refraction test (refractive value)
Measurement of corneal thickness, axial length, anterior chamber depth (measurement of central corneal thickness, axial length and anterior chamber depth)
QOL Survey (VFQ-25)
Oxidative stress marker (dROM), antioxidant value (BAP), AGE
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients over 20 years old at the time of informed consent
(2) Consent forms for entry into the registry were available
(3) Patients with glaucoma of the following types at enrollment (some patients were diagnosed before screening):
/ Primary open angle glaucoma (POAG): Characteristic morphological features of the optic disc and retinal nerve fiber layer, without other disease or congenital anomaly; and intraocular pressure > 20 mm Hg
/ Normal tension glaucoma (NTG): Characteristic morphological features of the optic nerve head and retinal nerve fiber layer, without other disease or congenital anomaly, and intraocular pressure < 20 mmHg
/ Preperimetric glaucoma (PPG): An ophthalmologic examination revealed abnormalities that suggested glaucoma, such as a glaucomatous optic nerve head or retinal nerve fiber layer defects, but no visual field defects were found in a visual field examination
/ Pseudo-exfoliation glaucoma (PEG): secondary glaucoma caused by pseudo-exfoliation syndrome
Key exclusion criteria
(1) History of treatment with unapproved or off-label uses of drugs in clinical trials (corporate clinical trials, physician-led clinical trials, or extended clinical trials), advanced medical treatments, or other clinical research
(2) Presence of serious systemic disease (such as cardiovascular disorder, liver disorder, renal disorder, or endocrine disease), with a judgement by the attending physician that participation in this study was inappropriate
(3) Judgement by the research director or assigned doctors that inclusion was inappropriate for other reasons
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Tsuda |
Organization
Tohoku University Hospital
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai , Miyagi 980-8574, Japan
TEL
022-717-7294
tsuda@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Tsuda |
Organization
Tohoku University Hospital
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai , Miyagi 980-8574, Japan
TEL
022-717-7294
Homepage URL
tsuda@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Drug Development and Regulatory Science, Faculty of Pharmacy, Keio University
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Medicine Ethics Committee
Address
1-1 Seiryo-machi, Aoba-ku, Sendai , Miyagi 980-8574, Japan
Tel
022-717-3867
med-kenkyo@grp.tohoku.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
| 2019 | Year | 08 | Month | 09 | 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
| 2019 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 07 | 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
isual function for several years.
Management information
Registered date
| 2019 | Year | 08 | Month | 08 | Day |
Last modified on
| 2021 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042421
