UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046063 |
|---|---|
| Receipt number | R000050951 |
| Scientific Title | Fovea-sparing internal limiting membrane peeling for epiretinal membrane foveoschisis based on new optical coherence tomography definition. |
| Date of disclosure of the study information | 2021/11/13 |
| Last modified on | 2021/11/12 21:30:21 |
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Basic information
Public title
Fovea-sparing internal limiting membrane peeling for epiretinal membrane foveoschisis based on new optical coherence tomography definition.
Acronym
Fovea-sparing internal limiting membrane peeling for epiretinal membrane foveoschisis
Scientific Title
Fovea-sparing internal limiting membrane peeling for epiretinal membrane foveoschisis based on new optical coherence tomography definition.
Scientific Title:Acronym
Fovea-sparing internal limiting membrane peeling for epiretinal membrane foveoschisis
Region
| Japan |
Condition
Condition
ERM foveoschisis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the visual and morphological outcomes of vitrectomy with fovea-sparing internal limiting membrane peeling (FSIP) for epiretinal membrane foveoschisis based on new optical coherence tomography definition.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Best corrected visual acuity, central macular thickness, presence of intraretinal cystoid space, post surgical severe complication(cystoid macular edema, full thickness macular hole ,rhegmatogenous retinal detachment, etc),recurrence of epiretinal membrane
Key secondary outcomes
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients were diagnosed epiretinal membrane foveoschisis and were done fovea-sparing internal limiting membrane membrane.
Key exclusion criteria
Exclusion criteria were: severe cataract of higher than grade 3, vitrectomised eye; high myopia defined by a n axial length (AL) longer than 26mm; secondary ERM (due to diabetic retinopathy, uveitis, retinal vascular disease); central retinal vein occlusion; uveitis; and other chorioretinal diseases such as diabetic retinopathy, hypertensive retinopathy, choroidal neovascularization.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Takagi |
Organization
St.Marianna university of medicine
Division name
Ophthalmology
Zip code
216-8511
Address
2-16 Sugao Miyamae-ku Kawasaki Kanagawa-ken
TEL
044-977-8111
r2sekine@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Reio |
| Middle name | |
| Last name | Sekine |
Organization
St.Marianna university of medicine
Division name
Ophthalmology
Zip code
216-8511
Address
2-16 Sugao Miyamae-ku Kawasaki Kanagawa-ken
TEL
044-977-8111
Homepage URL
r2sekine@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna university of medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Clinical Trials Review board of St. Marianna University School of Medicine
Address
2-16 Sugao Miyamae-ku Kawasaki Kanagawa-ken
Tel
044-977-8111
@marianna-u.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
| 2021 | Year | 11 | Month | 13 | 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
22
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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2021 | Year | 11 | Month | 12 | Day |
Last modified on
| 2021 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050951
