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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035094
Receipt No. R000040007
Official scientific title of the study Necessity of internal limiting membrane peeling in treatment of epiretinal membrane
Date of disclosure of the study information 2018/12/01
Last modified on 2018/12/01

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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

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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