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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029514
Receipt No. 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

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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
Email 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
Email tsawada@belle.shiga-med.ac.jp

Sponsor
Institute Department of Ophthalmology, Shiga University of Medical Science
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033725

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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