UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007286 |
|---|---|
| Receipt number | R000008580 |
| Scientific Title | Correlation between central macular thickness and visual outcome after successful macular hole surgery |
| Date of disclosure of the study information | 2012/02/20 |
| Last modified on | 2017/07/09 09:22:40 |
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Basic information
Public title
Correlation between central macular thickness and visual outcome after successful macular hole surgery
Acronym
Corelation between central macular thickness and visual outcome after macular hole surgery
Scientific Title
Correlation between central macular thickness and visual outcome after successful macular hole surgery
Scientific Title:Acronym
Corelation between central macular thickness and visual outcome after macular hole surgery
Region
| Japan |
Condition
Condition
idiopathic macular hole
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether central retinal thickness (CRT) at 1 month after surgery can be used to predict final visual outcome in eyes with idiopathic macular holes (MH).
Basic objectives2
Others
Basic objectives -Others
clinical availability
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
correlation between central retinal thickness and best-corrected visual acuity at 1 year after surgery
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases of macular hole diagnosed with a slit lamp examination and optic coherence tomography.
Key exclusion criteria
secondary macular hole, myopic eyes with a refractive error greater than -8.0 diopters, the history of ocular surgery and inflamation, the presence of other ocular diseases, intraoperative complications, cases with a long duration of preoperative symptoms exceeding 12 months, severe catgaract(more than greade 4 for any tyoe of cataract) by the LOCS III (lens opacity classification system)classification.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Takamura |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Ophthalmology
Zip code
Address
23-3 Matsuoka, Eiheiji, Yoshida, Fukui, Japan.
TEL
0776-61-8403
ytakamura@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Takamura |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Ophthalmology
Zip code
Address
23-3 Shimoaiduki Matsuoka Eiheiji Yoshida Fukui
TEL
0776-61-8403
Homepage URL
ytakamura@hotmail.com
Sponsor or person
Institute
Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui
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
| 2012 | Year | 02 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
prospective study
Management information
Registered date
| 2012 | Year | 02 | Month | 14 | Day |
Last modified on
| 2017 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008580
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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