UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041454
Receipt number 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 2022/10/28 14:23:53

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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 or person

Institute

Gunma university hospital

Institute

Department

Personal name



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

2022 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

2022 Year 10 Month 28 Day



Link to view the page

Value
https://center6.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