UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021116 |
|---|---|
| Receipt number | R000024364 |
| Scientific Title | Clinical trial phase 2 evaluating postoperative visual functions in eyes with epiretinal membrane with good visual acuity better than 0.9 decimal unit |
| Date of disclosure of the study information | 2016/02/20 |
| Last modified on | 2018/10/05 12:57:22 |
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Basic information
Public title
Clinical trial phase 2 evaluating postoperative visual functions in eyes with epiretinal membrane with good visual acuity better than 0.9 decimal unit
Acronym
Evaluating postoperative visual functions in eyes with ERM with good visual acuity better than 0.9 decimal unit
Scientific Title
Clinical trial phase 2 evaluating postoperative visual functions in eyes with epiretinal membrane with good visual acuity better than 0.9 decimal unit
Scientific Title:Acronym
Evaluating postoperative visual functions in eyes with ERM with good visual acuity better than 0.9 decimal unit
Region
| Japan |
Condition
Condition
epiretinal membrane
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of early vitrectomy for eyes with epiretinal membrane with good visual acuity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Horizontal metamorphopsia six months after surgery
Key secondary outcomes
Visual acuity
Horizontal metamorphopsia(1,3,12M)
Vertical metamorphopsia(1,3,6,12M)Vertical Aniseikonia test (1,3,6,12M)
Stereo test (1,3,6,12M)
evaluation of foveal thickness and IS/OS line by OCT
National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25)
Pathological findings
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Vitrectomy
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
1.eyes with epiretinal membrane
2.decimal visual acuity better than 0.9
3.age;over 20 years old
4.male/female
5.eyes without cataract which influence VA
6.systemic condition (ECOG PS 0-2)
7.internal organ function
8.informed consent
Key exclusion criteria
1.vitrectomized eye
2.eyes with intraoccular inflammation or retinal vascular diseases
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Nakashizuka |
Organization
Nihon University hospital
Division name
Ophthalmology
Zip code
Address
1-6 kanda surugadai chiyoda-ku
TEL
03-3293-1711
nakashizuka.hiroyuki@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Nakashizuka |
Organization
Nihon University hospital
Division name
Ophthalmology
Zip code
Address
1-6 kanda surugadai chiyoda-ku
TEL
03-3293-1711
Homepage URL
nakashizuka.hiroyuki@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University hospita
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
| 2016 | Year | 02 | Month | 20 | 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
| 2015 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 20 | Day |
Last modified on
| 2018 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024364
