UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021638 |
|---|---|
| Receipt number | R000024951 |
| Scientific Title | The study for early diagnosis of glaucoma and the detection of glaucomatous progression. |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2017/03/29 00:12:04 |
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Basic information
Public title
The study for early diagnosis of glaucoma and the detection of glaucomatous progression.
Acronym
The study for early diagnosis of glaucoma.
Scientific Title
The study for early diagnosis of glaucoma and the detection of glaucomatous progression.
Scientific Title:Acronym
The study for early diagnosis of glaucoma.
Region
| Japan |
Condition
Condition
Glaucoma, Glaucoma suspects
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To establish methods for early diagnosis of glaucoma and detection of glaucomatous progression depending on the morphological clasification of the optic nerve head.
2) To apply the results to clinical use conbing with the database of glaucoma patients.
Basic objectives2
Others
Basic objectives -Others
Prospective, observation studies.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Value of clinical parameters collected at every visit when glaucoma progress.
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The objects of this study are glaucoma patients and glacuoma suspects.This determination was made according to the recommendations of the Japan Glaucoma Society Guidelines for Glaucoma.All patients need to undergo clinical examination including observations of anterior chamber angle and optic disc and visual field test.Glaucoma is defined as a patient with visual field defects corresponding to the glaucomatous change of optic nerve head.Glaucoma suspect is defined as a patient with glaucomatous optic nerve head appearance without visual field defects.Informed consent is needed for entry.
Key exclusion criteria
1. When doctor determine an patint ineligible.
2. IOP is unmeasurable.
3. Ocular fundus is unobservable.
4. Informed consent can not be obtained due to cognitive deterioration.
5. Scheduled examinations can not be performed.
Target sample size
320
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Nakazawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, JAPAN
TEL
0227177294
ntoru@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yu Yokoyama |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, JAPAN
TEL
0227177294
Homepage URL
yu-yokoyama@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
KOWA Company.Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 04 | 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
| 2015 | Year | 06 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective, observation study.
Patients is recruted from Jun, 2015 and clinical data is collected for 5 years.
Management information
Registered date
| 2016 | Year | 03 | Month | 27 | Day |
Last modified on
| 2017 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024951
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
