UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043234 |
|---|---|
| Receipt number | R000049339 |
| Scientific Title | Subthreshold Micropulse 532nm Green Laser Treatment of Acute Central Serous Chorioretinopathy |
| Date of disclosure of the study information | 2021/02/03 |
| Last modified on | 2021/02/03 08:04:54 |
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Basic information
Public title
Subthreshold Micropulse Laser Treatment of Acute Central Serous Chorioretinopathy
Acronym
GSML Treatment of Acute CSCR
Scientific Title
Subthreshold Micropulse 532nm Green Laser Treatment of Acute Central Serous Chorioretinopathy
Scientific Title:Acronym
GSML 523 nm treatment of Acute CSCR
Region
| Africa |
Condition
Condition
patients with any age, any sex suffering from acute type of CSCR. Exclusion criteria included any causes of drop of vision other than CSCR and patients who received any other form of treatment.
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of 532nm green subthreshold micropulse laser as a treatment for acute central serous chorioretinopathy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The mean base line best corrected visual acuity significantly improved after 18 months.
Key secondary outcomes
The mean central macular thickness show statistically significant reduction after 18 months of trestement
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
green subthreshold micropulse laser
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
| 25 | years-old | <= |
Age-upper limit
| 44 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Any age, any sex suffering from acute type of CSCR.
Key exclusion criteria
Exclusion criteria included any causes of drop of vision other than CSCR and patients who received any other form of treatment.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Asmaa |
| Middle name | Anwar |
| Last name | Mohamed |
Organization
Minia University Hospital
Division name
ophthalmology departement
Zip code
61623
Address
24th 6 october street taha hussein minya
TEL
01006048882
asmaa.anwar@mu.edu.eg
Public contact
Name of contact person
| 1st name | heba |
| Middle name | Radi |
| Last name | Attallah |
Organization
Minis University Hospital
Division name
Heba Radi Attallah
Zip code
61623
Address
Minia university
TEL
01002554107
Homepage URL
hebaradi1974@gmail.com
Sponsor or person
Institute
Minia University Hospital,Opthalmology department
Institute
Department
Personal name
Funding Source
Organization
Minia University Hospital ,Minia university , ophthalmology department
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asmaa Anwar Mohamed
Address
24th 6 october street taha hussein minya
Tel
0100604882
asmaa.anwar@mu.edu.eg
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
| 2021 | Year | 02 | Month | 03 | Day |
Related information
URL releasing protocol
The mean log-MAR base line best corrected visual acuity significantly improved
Publication of results
Unpublished
Result
URL related to results and publications
The mean log-MAR base line best corrected visual acuity significantly improved
Number of participants that the trial has enrolled
42
Results
The mean base line best corrected visual acuity significantly improved after three months and after 18 months. The mean central macular thickness show statistically significant reduction after 18 months . As regard the presence of sub-foveal fluid, it absent in 40 eyes while recurrence of subretinal fluid was present in only 2 eye . No complications were encountered during or after laser treatment.
Results date posted
| 2021 | Year | 02 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean base line best corrected visual acuity . The mean central macular thickness .
Participant flow
All eyes were followed up for one month, 3 months, 6 months, 12 months and 18 months after laser treatment. Follow up measures included the change in BCVA, central macular thickness (CMT) and the presence or absence of sub-foveal fluid in comparison with the baseline evaluation.
Adverse events
No complications were encountered during or after laser treatment.
Outcome measures
The mean base line best corrected visual acuity . The mean central macular thickness .
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 03 | Day |
Last modified on
| 2021 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049339
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