UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036009 |
|---|---|
| Receipt number | R000041014 |
| Scientific Title | The retinal and choroidal displacement after vitrectomy in eyes with macular hole |
| Date of disclosure of the study information | 2019/02/26 |
| Last modified on | 2019/02/26 09:10:07 |
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Basic information
Public title
The retinal and choroidal displacement after vitrectomy in eyes with macular hole
Acronym
The retinal and choroidal displacement after vitrectomy in eyes with macular hole
Scientific Title
The retinal and choroidal displacement after vitrectomy in eyes with macular hole
Scientific Title:Acronym
The retinal and choroidal displacement after vitrectomy in eyes with macular hole
Region
| Japan |
Condition
Condition
macular hole
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The macular displacement after vitrectomy in eyes with macular hole has been reported in previous studies. The aim of our study is to clarify the retinal and choroidal displacement after vitrectomy in eyes with macular hole using OCT (optical coherence tomography) 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 macular hole surgery from 1 January 2016 to 31 March 2020
Key exclusion criteria
nothing special
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Iwase |
Organization
Nagoya University School of Medicine
Division name
Department of Opthalmology
Zip code
Address
Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture
TEL
052-744-2275
tiwase@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kensuke Goto |
Organization
Nagoya University School of Medicine
Division name
Department of Opthalmology
Zip code
Address
Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture
TEL
052-744-2275
Homepage URL
kensuke.goto1214@gmail.com
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
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)
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
| 2019 | Year | 02 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing special
Management information
Registered date
| 2019 | Year | 02 | Month | 26 | Day |
Last modified on
| 2019 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041014
