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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030292
Receipt No. 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 2019/02/20

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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.
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
Middle name
Last name Kunihiko Akiyama
Organization National Hospital Organization, Tokyo Medical Center
Division name Ophthalmology
Zip code
Address 2-5-1, Higashigaoka, Meguro-ku, Tokyo, Japan
TEL 03-3411-0111
Email akiyama.kunihiko.gs@mail.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kunihiko Akiyama
Organization National Hospital Organization, Tokyo Medical Center
Division name Ophthalmology
Zip code
Address 2-5-1, Higashigaoka, Meguro-ku, Tokyo, Japan
TEL 03-3411-0111
Homepage URL
Email akiyama.kunihiko.gs@mail.hosp.go.jp

Sponsor
Institute National Hospital Organization, Institute of Sensory Organs, Tokyo Medical Center
Institute
Department

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
Address
Tel
Email

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 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 Open public recruiting
Date of protocol fixation
2017 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 06 Day
Last follow-up date
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
2019 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034594

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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