UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026065
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email ariearly7@gmail.com

Sponsor
Institute Nihon University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029626

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.