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 | 2025/02/20 17:52:02 |
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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
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
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
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
https://doi.org/10.1007/s10384-023-00976-x
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s10384-023-00976-x
Number of participants that the trial has enrolled
20
Results
Subfoveal choroidal thickness significantly decreased in both the quadrant laser group and the external control group, with a more pronounced reduction observed in the quadrant laser group. The vertical diameter of the dilated vortex vein significantly decreased only in the quadrant laser group. The resolution rate of serous retinal detachment was similar between the two groups. In the quadrant laser group, mild visual field deterioration was observed in 8 eyes (44.4%).
Results date posted
| 2025 | Year | 02 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The number of eyes included in the study was 18 in both the quadrant laser group and the external control group. The age was 45.0+-7.1 years in the quadrant laser group and 48.0+-9.1 years in the external control group, with no significant difference between the groups (P=0.29).The proportion of male patients was 12 (66.7%) in the quadrant laser group and 16 (88.9%) in the external control group, with no significant difference between the groups (P=0.11). The number of leakage points was 1.2+-0.5 in the quadrant laser group and 1.1+-0.2 in the external control group, with no significant difference between the groups (P=0.28).
The subfoveal choroidal thickness was 380+-100um in the quadrant laser group and 393+-89um in the external control group, with no significant difference between the groups (P=0.71). The vertical diameter of the dilated vortex vein was 320+-58um in the quadrant laser group and 295+-50um in the external control group, with no significant difference between the groups (P=0.21). The foveal thickness was 394+-134um in the quadrant laser group and 369+-147um in the external control group, with no significant difference between the groups (P=0.61). The best corrected visual acuity (logMAR) was -0.01+-0.12 in the quadrant laser group and 0.00+-0.09 in the external control group, with no significant difference between the groups (P=0.30).
Participant flow
We prospectively studied 20 eyes with acute central serous chorioretinopathy in the quadrant laser group, in which laser photocoagulation was applied to the macular leakage point(s) as well as the quadrant of the fundus showing vortex vein dilatation. Central choroidal thickness, vertical diameter of dilated vortex vein, resolution rate of serous retinal detachment, and visual field were evaluated post-treatment. We also compared the results with those of 18 retrospectively analyzed eyes with acute central serous chorioretinopathy in an external control group, in which laser photocoagulation had been applied only to the macular leakage point(s).
Adverse events
Choroidal neovascularization developed in 2 eyes.
Outcome measures
Central choroidal thickness, vertical diameter of the dilated vortex vein, and foveal thickness were measured on vertical B-mode optical coherence tomography images using the computer-based caliper measurement tool included in the optical coherence tomography system. Central choroidal thickness was defined as the distance between Bruchs membrane and the margin of the choroid and sclera under the fovea. Vertical diameter of the dilated vortex vein was defined as the vertical diameter of the most dilated outer choroidal vessel present in proximity to the area subjected to quadrant laser photocoagulation. Foveal thickness was defined as the distance between the internal limiting membrane and the inner surface of the retinal pigment epithelium at the fovea. The presence of serous retinal detachment was determined based on horizontal, vertical, and radial B-mode optical coherence tomography imaging findings. Best-corrected visual acuity was determined with manifest refraction and recorded as decimal values and then converted to the logarithm of the minimal angle of resolution (logMAR) units.The primary endpoint was the change from baseline in central choroidal thickness at 12 weeks after the initial laser treatment. Secondary endpoints were the change from baseline in vertical diameter of the dilated vortex vein and the resolution rate of serous retinal detachment at 12 weeks after the initial treatment.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2025 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047269
