UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030292 |
|---|---|
| Receipt number | R000034594 |
| Scientific Title | Indication of internal limiting membrane peeling during vitrectomy for retinal detachment repair to prevent post-surgical epiretinal membrane growth |
| Date of disclosure of the study information | 2017/12/06 |
| Last modified on | 2023/06/13 15:24:16 |
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Basic information
Public title
Indication of internal limiting membrane peeling during vitrectomy for retinal detachment repair to prevent post-surgical epiretinal membrane growth
Acronym
ILM peeling for prevention of post-surgical ERM growth after retinal detachment repair
Scientific Title
Indication of internal limiting membrane peeling during vitrectomy for retinal detachment repair to prevent post-surgical epiretinal membrane growth
Scientific Title:Acronym
ILM peeling for prevention of post-surgical ERM growth after retinal detachment repair
Region
| Japan |
Condition
Condition
Rhegmatogenous retinal detachment
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish a method to select cases to which ILM peeling during vitrectomy for retinal detachment repair is beneficial in terms of prevention of postsurgical ERM growth.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence of ERM growth at 6 and 12months postoperatively.
Key secondary outcomes
Best-corrected visual acuity at 6 and 12 months postoperatively.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
ILM is peeled if retinal surface wrinkling is observed in the macula during vitrectomy and/or on OCT images (5 line protocol and en face analyses).
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Initial surgery for rhegmatogenous retinal detachment.
Key exclusion criteria
Proliferative vitreoretinopathy and history of any macular disorder except for epiretinal membrane.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kunihiko |
| Middle name | |
| Last name | Akiyama |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Ophthalmology
Zip code
152-8902
Address
2-5-1, Higashigaoka, Meguro-ku, Tokyo, Japan
TEL
03-3411-0111
akiyama.kunihiko.gs@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Kunihiko |
| Middle name | |
| Last name | Akiyama |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Ophthalmology
Zip code
152-8902
Address
2-5-1, Higashigaoka, Meguro-ku, Tokyo, Japan
TEL
03-3411-0111
Homepage URL
akiyama.kunihiko.gs@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization, Institute of Sensory Organs, Tokyo Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional Review Board of National Hospital Organization Tokyo Medical Center
Address
2-5-1, Higashigaoka, Meguro-ku, Tokyo, Japan
Tel
03-3411-0111
215-rinri@mail.hosp.go.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
国立病院機構東京医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 06 | Day |
Last modified on
| 2023 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034594
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
