UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035094 |
|---|---|
| Receipt number | R000040007 |
| Scientific Title | 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 02:20:27 |
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Basic information
Public title
Necessity of internal limiting membrane peeling in treatment of epiretinal membrane
Acronym
Necessity of internal limiting membrane peeling in treatment of epiretinal membrane
Scientific Title
Necessity of internal limiting membrane peeling in treatment of epiretinal membrane
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takashi Kitaoka |
Organization
Graduate School of Biomedical Sciences, Nagasaki University
Division name
Department of Ophthalmology and Visual Sciences
Zip code
Address
Sakamoto 1-7-1, Nagasaki, 852-8501
TEL
0958197345
tkitaoka@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryota Kono |
Organization
Graduate School of Biomedical Sciences, Nagasaki University
Division name
Department of Ophthalmology and Visual Sciences
Zip code
Address
Sakamoto 1-7-1, Nagasaki, 852-8501
TEL
0958197345
Homepage URL
kounoryouta818@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Nagasaki University Hospital
Institute
Department
Personal name
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
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 17 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040007
