UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057260 |
|---|---|
| Receipt number | R000065426 |
| Scientific Title | Observational Study on the Clinical Course of Glaucoma and Ocular Hypertension |
| Date of disclosure of the study information | 2025/03/15 |
| Last modified on | 2025/03/11 18:11:17 |
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Basic information
Public title
Observational Study on the Clinical Course of Glaucoma and Ocular Hypertension
Acronym
Observational Study on Glaucoma
Scientific Title
Observational Study on the Clinical Course of Glaucoma and Ocular Hypertension
Scientific Title:Acronym
Observational Study on the Clinical Course of Glaucoma and Ocular Hypertension
Region
| Japan |
Condition
Condition
Glaucoma and Ocular Hypertension
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to identify factors that influence the progression of glaucomatous visual impairment (including visual acuity loss and visual field deterioration), as well as the progression of glaucomatous optic nerve head and retinal damage, and the effectiveness of treatment. This will be achieved by enrolling patients with glaucoma and ocular hypertension and analyzing background factors and examination parameters at the time of registration.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Intraocular pressure
Key secondary outcomes
Visual field, retinal thickness, optic nerve head shape, retinal and optic nerve blood flow, cornea, angle, ciliary body, visual acuity, subjective symptoms, side effects, 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients attending outpatient clinics for glaucoma or ocular hypertension at our hospital:
The patient must have glaucoma or ocular hypertension in at least one eye. The diagnosis of glaucoma follows the glaucoma guidelines, which include cases of pre-perimetric glaucoma.
2. Patients who have visited our hospital for glaucoma or ocular hypertension since 2015:
These patients will be considered for inclusion in the study.
3. No age restrictions:
There are no specific age limitations for inclusion in the study.
Key exclusion criteria
None.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Hanako |
| Middle name | |
| Last name | Ikeda |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Ophthalmology
Zip code
5698686
Address
Diagaku-cho 2-7, Takatsuki-shi
TEL
0726831221
hanako.ikeda@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Hanako |
| Middle name | |
| Last name | Ikeda |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Ophthalmology
Zip code
5698686
Address
Daigaku-cho 2-7, Takatsuki-shi
TEL
0726831221
Homepage URL
hanako.ikeda@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University
Address
Daigaku-cho 2-7, Takatsuki-shi
Tel
0726831221
hanako.ikeda@ompu.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
| 2025 | Year | 03 | Month | 15 | 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
| 2025 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2030 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NP
Management information
Registered date
| 2025 | Year | 03 | Month | 11 | Day |
Last modified on
| 2025 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065426
