UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026065 |
|---|---|
| Receipt number | R000029626 |
| Scientific Title | Foveal Avascular Zone Area Analysis in Macular Hole Before and After Surgery using Optical Coherence Tomography Angiography |
| Date of disclosure of the study information | 2017/02/13 |
| Last modified on | 2019/03/05 19:40:52 |
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Basic information
Public title
Foveal Avascular Zone Area Analysis in Macular Hole Before and After Surgery using Optical Coherence Tomography Angiography
Acronym
Macular Hole FAZ
Scientific Title
Foveal Avascular Zone Area Analysis in Macular Hole Before and After Surgery using Optical Coherence Tomography Angiography
Scientific Title:Acronym
Macular Hole FAZ
Region
| Japan |
Condition
Condition
Macular hole
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the foveal avascular zone area (FAZ) in macular hole (MH) patients preoperatively and 6 months postoperatively at the superficial vascular and deep vascular layer levels, for comparison with a control group using OCT angiography.
Basic objectives2
Others
Basic objectives -Others
To analyze the minimum diameter and basal diameter of the hole, vertically and horizontally, employing a built-in caliper in the OCT.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FAZ in MH patients preoperatively and postoperatively
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were unilateral MH.
Key exclusion criteria
Cases with a myopic refractive error exceeding 6.0 Diopters and/or a history of other retinal diseases were excluded from this study.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ari SHINOJIMA |
Organization
Nihon University School of Medicine
Division name
Divison of Ophthalmology, Department of Visual Sciences
Zip code
Address
1-6 Surugadai, Kanda, Chiyoda-ku, Tokyo
TEL
03-3293-1711
ariearly7@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ari SHINOJIMA |
Organization
Nihon University School of Medicine
Division name
Divison of Ophthalmology, Department of Visual Sciences
Zip code
Address
1-6 Surugadai, Kanda, Chiyoda-ku, Tokyo
TEL
03-3293-1711
Homepage URL
ariearly7@gmail.com
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine
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
| 2017 | Year | 02 | Month | 13 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/29772043
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29772043
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
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | 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
We retrospectively studied 14 eyes of 14 consecutive patients with unilateral MH without a history of other retinal diseases who underwent vitrectomy with pre- and postoperative OCTA images of good quality. Data were analyzed using descriptive statistics. We used the paired t test to analyze the correlations among FAZ areas in the superficial and deep layers pre- and postoperatively. The unpaired t test was employed to analyze the MH and the findings in the fellow eye. Statistical analyses were performed using Stat View (SAS Institute Inc., Cary, NC, USA).
Management information
Registered date
| 2017 | Year | 02 | Month | 09 | Day |
Last modified on
| 2019 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029626
| 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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