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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041454
Receipt No. R000047269
Scientific Title Retinal laser photocoagulation to ameliorate choroidal congestion in central serous chorioretinopathy
Date of disclosure of the study information 2020/09/01
Last modified on 2020/08/18

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Basic information
Public title Retinal laser photocoagulation to ameliorate choroidal congestion in central serous chorioretinopathy
Acronym Retinal laser photocoagulation for central serous chorioretinopathy
Scientific Title Retinal laser photocoagulation to ameliorate choroidal congestion in central serous chorioretinopathy
Scientific Title:Acronym Retinal laser photocoagulation for central serous chorioretinopathy
Region
Japan

Condition
Condition Central serous chorioretinopathy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Retinal laser photocoagulation in the macular area is a standard treatment for central serous chorioretinopathy. In the current study, we investigate the efficacy of additional retinal laser photocoagulation in the peripheral area with choroidal congestion to ameliorate the choroidal congestion leading to reduced choroidal thickness.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The reduction of central choroidal thickness 12 weeks after retinal laser photocoagulation.
Key secondary outcomes The reduction of diameters of choroidal veins and absorption of serous retinal detachment 12 weeks after retinal laser photocoagulation.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 We perform retinal laser photocoagulation in the peripheral area showing choroidal congestion in addition to the macular area for all the participants.
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
70 years-old >
Gender Male and Female
Key inclusion criteria 1) Having been diagnosed with central serous chorioretinopathy
2) Having no other fundus diseases
3) Having not received any treatments for central serous chorioretinopathy
4) Being an outpatient
5) Having given written consent to participate the current study
Key exclusion criteria 1) Showing dye leakage under the fovea or diffuse leakage in fluorescein angiography
2) Having received any steroid therapies
3) Having intraocular pressure of 21mmHg or more in the eye with central serous chorioretinopathy
4) Having been judged by doctors as inappropriate participants for the current study

Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hideo
Middle name
Last name Akiyama
Organization Gunma University, School of Medicine
Division name Ophthalmology
Zip code 371-8511
Address 3-39-15 Showa-machi, Maebashi, Gunma, 371-8511
TEL 027-220-8338
Email akiyamah4@gunma-u.ac.jp

Public contact
Name of contact person
1st name Hidetaka
Middle name
Last name Matsumoto
Organization Gunma University, School of Medicine
Division name Ophthalmology
Zip code 371-8511
Address 3-39-15 Showa-machi, Maebashi, Gunma, 371-8511
TEL 027-220-8338
Homepage URL
Email hide-m@gunma-u.ac.jp

Sponsor
Institute Gunma university hospital
Institute
Department

Funding Source
Organization Department of Ophthalmology, Gunma University, School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional review board of Gunma university hospital
Address 3-39-15 Showa-machi, Maebashi, Gunma, 371-8511
Tel 0272208740
Email gunmaciru-office@umin.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
2020 Year 09 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 Preinitiation
Date of protocol fixation
2020 Year 08 Month 12 Day
Date of IRB
2020 Year 08 Month 12 Day
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 18 Day
Last modified on
2020 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047269

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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