UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Foveal Avascular Zone Area Analysis in Macular Hole Before and After Surgery using Optical Coherence Tomography Angiography
Title of the study (Brief title)	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	Ari SHINOJIMA
Organization	Nihon University School of Medicine
Division name	Divison of Ophthalmology, Department of Visual Sciences
Address	1-6 Surugadai, Kanda, Chiyoda-ku, Tokyo
TEL	03-3293-1711
Email	ariearly7@gmail.com

Public contact
Name of contact person	Ari SHINOJIMA
Organization	Nihon University School of Medicine
Division name	Divison of Ophthalmology, Department of Visual Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 01 Day
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

Related information
URL releasing protocol	https://www.ncbi.nlm.nih.gov/pubmed/29772043
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/29772043
Results
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