UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Necessity of internal limiting membrane peeling in treatment of epiretinal membrane
Title of the study (Brief title)	Necessity of internal limiting membrane peeling in treatment of epiretinal membrane
Region	Japan

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

Objectives
Narrative objectives1	To investigate the equivalence of retinal sensitivity in cases which the internal limiting membrane is removed or not in surgery of epiretinal membrane.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Retinal sensitivity at preoperative and postoperative 1 month, 3 months, 6 months
Key secondary outcomes	Visual acuity and central macular thickness at preoperative and postoperative 1, 3 3, 6 months

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	with internal limiting membrane peeling in surgery for epiretinal membrane
Interventions/Control_2	without internal limiting membrane peeling in surgery for epiretinal membrane
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients with idiopathic epiretinal membrane 2. Patients who have subjective symptoms and objective findings of dysphagia or decreased vision. 3. Patients who aged 20 years or older and under 90 years old at the time of consent acquisition 4. After receiving sufficient explanation for participation in this study, patients who obtained document consent by the patient's free will with sufficient understanding
Key exclusion criteria	Patients applicable to even one of the following are excluded as subjects. 1. Patients with secondary epiretinal membrane (traumatic, retinal hiatus, retinal vascular lesions etc). 2. A patient forming a pseudo macular hole. 3. Patients who have complicated other eye diseases affecting visual field narrowing such as glaucoma. 4. Patients who are cloudy with cornea and intermediate translucency. 5. Patient with a history of vitrectomy 6. Patients with myopia with an axial axis of 25.00 mm or more or 6.00 D or more. 7. In addition, patients whose research managers judged inappropriate as subjects
Target sample size	60

Research contact person
Name of lead principal investigator	Takashi Kitaoka
Organization	Graduate School of Biomedical Sciences, Nagasaki University
Division name	Department of Ophthalmology and Visual Sciences
Address	Sakamoto 1-7-1, Nagasaki, 852-8501
TEL	0958197345
Email	tkitaoka@nagasaki-u.ac.jp

Public contact
Name of contact person	Ryota Kono
Organization	Graduate School of Biomedical Sciences, Nagasaki University
Division name	Department of Ophthalmology and Visual Sciences
Address	Sakamoto 1-7-1, Nagasaki, 852-8501
TEL	0958197345
Homepage URL
Email	kounoryouta818@nagasaki-u.ac.jp

Sponsor
Institute	Department of Ophthalmology, Nagasaki University Hospital
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)

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	2018 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 17 Day
Anticipated trial start date	2014 Year 12 Month 17 Day
Last follow-up date	2018 Year 08 Month 31 Day
Date of closure to data entry	2018 Year 08 Month 31 Day
Date trial data considered complete	2018 Year 08 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 12 Month 01 Day
Last modified on	2018 Year 12 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040007