UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033005 |
|---|---|
| Receipt number | R000037462 |
| Scientific Title | Clinical study about distortion in patients with macular hole. |
| Date of disclosure of the study information | 2018/06/20 |
| Last modified on | 2019/06/15 12:46:04 |
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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
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
mizu@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Fujita Health University School of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037462
