UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029514 |
|---|---|
| Receipt number | R000033725 |
| Scientific Title | Evaluation of effectiveness of the cone contrast test in chorioretinal disease |
| Date of disclosure of the study information | 2017/10/11 |
| Last modified on | 2017/10/11 20:58:44 |
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Basic information
Public title
Evaluation of effectiveness of the cone contrast test in chorioretinal disease
Acronym
Evaluation of effectiveness of the cone contrast test in chorioretinal disease
Scientific Title
Evaluation of effectiveness of the cone contrast test in chorioretinal disease
Scientific Title:Acronym
Evaluation of effectiveness of the cone contrast test in chorioretinal disease
Region
| Japan |
Condition
Condition
diabetic retinopathy, diabetic macular edema, central retinal vein occlusion, branch retinal vein occlusion, age-related macular degeneration, myopic choroidal neovascularization, central serous chorioretinopathy, idiopathic choroidal neovascularization
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate acquired color vision deficiency of chorioretinal disease and effectiveness of treatment using the cone contrast test
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The results of cone contrast test before and after treatment
Key secondary outcomes
Correlation between Cone contrast test and visual acuity
Correlation between Cone contrast test and optical coherence tomography findings
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
Patients who are diagnosed as below: diabetic retinopathy, diabetic macular edema, central retinal vein occlusion, branch retinal vein occlusion, age-related macular degeneration, myopic choroidal neovascularization, central serous chorioretinopathy, idiopathic choroidal neovascularization.
Patients provided informed written consent before participation and agreed to participate to this study.
Patients who can read alphabet.
Key exclusion criteria
Patients with congenital color-vision deficiencies
Patients who refused to participate this study, or patients who are judged to be unfit as the participants of this study
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahito Ohji |
Organization
Shiga University of Medical Science
Division name
Department of Ophthalmology
Zip code
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
077-548-2276
ohji@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Sawada |
Organization
Shiga University of Medical Science
Division name
Department of Ophthalmology
Zip code
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
077-548-2276
Homepage URL
tsawada@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Shiga University of Medical Science
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
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
滋賀医科大学眼科
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 11 | 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
| 2017 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Participants: Patients who are diagnosed as below: diabetic retinopathy, diabetic macular edema, central retinal vein occlusion, branch retinal vein occlusion, age-related macular degeneration, myopic choroidal neovascularization, central serous chorioretinopathy, idiopathic choroidal neovascularization.
Patients provided informed written consent before participation and agreed to participate to this study.
Patients who can read alphabet.
Outcomes:
The results of cone contrast test before and after treatment
Correlation between Cone contrast test and visual acuity
Correlation between Cone contrast test and optical coherence tomography findings
Management information
Registered date
| 2017 | Year | 10 | Month | 11 | Day |
Last modified on
| 2017 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033725
| Research Plan | |
|---|---|
| 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 |
