UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of inner limiting membrane peeling on retinal thickness and retinal vascular layer for epiretinal membrane and macular hole
Title of the study (Brief title)	Effect of ILM peeling for ERM and MH
Region	Japan

Condition
Condition	epiretinal membrane macular hole
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Internal limiting membrane peeling is performed intraoperatively for epiretinal membrane and macular hole, but the influence on postoperative retinal thickness and retinal vascular layer has not been clarified. We will evaluate preoperatively and postoperatively by RS 3000 and OCT angiography
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sex,age,visual acuity,visual field,refraction,corneal curvature radius,corneal thickness,ocular axial length,fundus observation,optical coherence tomography,optical coherence tomography angiography,fundus photograph,fluorescence angiography,slit lamp microscopy,duration of disease,current medical history,past hisory,family history,medication used surgery content
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent epiretinal menbrane and macular hole surgery from 1 April 2017 to 31 March 2020
Key exclusion criteria	nothing special
Target sample size	100

Research contact person
Name of lead principal investigator	Hiroki kaneko
Organization	Nagoya University Hospital
Division name	Department of Ophthalmology
Address	65 Tsurumai-cho,Showa-ku,Nagoya
TEL	052-744-2275
Email	hiroki.kaneko2@gmail.com

Public contact
Name of contact person	Hiroki kaneko
Organization	Nagoya University Hospital
Division name	Department of Ophthalmology
Address	65 Tsurumai-cho,Showa-ku,Nagoya
TEL	052-744-2275
Homepage URL
Email	hiroki.kaneko2@gmail.com

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Nagoya University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 04 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 04 Month 01 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	nothing special

Management information
Registered date	2017 Year 02 Month 18 Day
Last modified on	2017 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030108