UMIN-CTR Clinical Trial

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
Email	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
Email	r2sekine@marianna-u.ac.jp

Sponsor
Institute	St.Marianna university of medicine
Institute
Department

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
Email	@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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050951