UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study about distortion in patients with macular hole.
Acronym	Clinical study about distortion in patients with macular hole.
Scientific Title	Clinical study about distortion in patients with macular hole.
Scientific Title:Acronym	Clinical study about distortion in patients with macular hole.
Region	Japan

Condition
Condition	macular hole
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To measure the extent of photoreceptor displacement in patients with macular hole using the Watzke-Allen test (WAT) and compare the displacement value with the diameter of the hole measured by optical coherence tomography (OCT).
Basic objectives2	Others
Basic objectives -Others	To measure the extent of photoreceptor displacement in patients with macular hole, how it affect the visual function and anatomy.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Horizontal and vertical Watzke-Allen test thresholds for distortion a month before surgery.
Key secondary outcomes	The vertical and horizontal macular hole diameters measured by OCT a month before surgery. Best corrected visual acuity a month before surgery. age male/female

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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Object Patients who are diagnosed for idiopathic macular hole at Fujita Health University Hospital and who will be underwent surgery within one month. All patients provided written informed consent before entry.
Key exclusion criteria	1.Patients who can not understand the way of the examination,or patients who hope cancellation of the examination. 2. Patients who are judged inadequate by principal investigator and investigators 3.Patients whose examination record can not be confirmed.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masayuki Middle name Last name Horiguchi
Organization	Fujita Health University School of medicine
Division name	Department of Ophthalmology
Zip code	4701192
Address	postal code 470-1192 , Kustukake-chou, 1-98. Toyoake, Aichi, japan
TEL	0562932097
Email	Masayuki@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Tadashi Middle name Last name Mizuguchi
Organization	Fujita Health University School of medicine
Division name	Department of Ophthalmology
Zip code	4701192
Address	postal code 470-1192 , Kustukake-chou, 1-98. Toyoake, Aichi, japan
TEL	0562932097
Homepage URL
Email	mizu@fujita-hu.ac.jp

Sponsor
Institute	Department of Ophthalmology, Fujita Health University School of medicine
Institute
Department

Funding Source
Organization	Fujita Health University School of medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fujita Health University School of medicine IRB
Address	postal code 470-1192 , Kustukake-chou, 1-98. Toyoake, Aichi, japan
Tel	0562-93-2865
Email	kenshien@fujita-hu.ac.jp

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	2018 Year 06 Month 20 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	Completed
Date of protocol fixation	2018 Year 06 Month 01 Day
Date of IRB	2018 Year 07 Month 06 Day
Anticipated trial start date	2018 Year 07 Month 06 Day
Last follow-up date	2019 Year 06 Month 01 Day
Date of closure to data entry	2019 Year 06 Month 02 Day
Date trial data considered complete	2019 Year 06 Month 10 Day
Date analysis concluded	2019 Year 07 Month 10 Day

Other

Other related information

Purpose and significance of research (overview) In macular hole, the retinal traction by the vitreous body causes centrally located visual cells to displace to an efferent state, thereby recognizing characteristic distortion vision. However, there is no way to directly measure the displacement of photoreceptors. In this study, we quantify stereo vision and estimate the range of displacement of photoreceptor cells by prospectively examining the correlation between the optical coherence tomography (OCT) and the image data. If we can estimate the movement range of photoreceptor cell, we can see how it affects visual function and dissection before and after surgery Methods:All the subjects will be underwent a complete preoperative assessment, including measurement of corrected visual acuity, slit-lamp examination of the anterior chamber of the eye, and mydriatic funduscopy with a 90-diopter lens and a monocular indirect ophthalmoscope . Horizontal and vertical spectral-domain OCT of the macular region will be performed. We devise a method for determining the WAT threshold for distortion, which indicates the extent of displacement of photoreceptors. The WAT will be performed with the slit displayed on a monitor screen and patients wearing their usual glasses to enable them to focus on the screen. The initial width of the slit will be a 0.5degrees visual angle, and this will be increased in 0.5 degrees increments until thinning will be no longer observed. The final width at which thinning will be reported was taken to be the threshold value.

Management information
Registered date	2018 Year 06 Month 15 Day
Last modified on	2019 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037462