UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039222 |
|---|---|
| Receipt number | R000044731 |
| Scientific Title | Preoperative evaluation for vitreous gel by using ultrasound elastography |
| Date of disclosure of the study information | 2020/01/22 |
| Last modified on | 2021/07/28 12:57:58 |
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Basic information
Public title
Preoperative evaluation for vitreous gel by using ultrasound elastography
Acronym
Preoperative evaluation for vitreous gel by using ultrasound elastography
Scientific Title
Preoperative evaluation for vitreous gel by using ultrasound elastography
Scientific Title:Acronym
Preoperative evaluation for vitreous gel by using ultrasound elastography
Region
| Japan |
Condition
Condition
Vitreoretinal diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims at the evaluation for the structure and elasticity of bursa premacularis and martegiani's area by using ultrasound elastography in the patients with vitreoretinal diseases before vitreous surgery.
Basic objectives2
Others
Basic objectives -Others
To perform the vitreous surgery smoothly by grasping the preoperative pathophysiology of vitreoretinal diseases.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To draw the structure of eye ball by using ultrasound elastography (Ultrasound Aplio i700TM, Canon Medical Systems) in the patients before vitreous surgery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
To draw the structure of eye ball by using ultrasound elastography.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients more than 40 years old who are subjected to vitreous surgery for vitreoretinal diseases.
Key exclusion criteria
The patients who had the past history of intraocular surgery are excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tsunehiko |
| Middle name | |
| Last name | Ikeda |
Organization
Osaka Medical College
Division name
Department of Ophthalmology
Zip code
569-8686
Address
2-7 Daigaku-machi Takatsuki-City
TEL
072-683-1221
tikeda@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Tsunehiko |
| Middle name | |
| Last name | Ikeda |
Organization
Osaka Medical College
Division name
Department of Ophthalmology
Zip code
569-8686
Address
2-7 Daigaku-machi Takatsuki-City
TEL
072-683-1221
Homepage URL
tikeda@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Osaka Medical College
Address
2-7 Daigaku-machi Takatsuki-City, Osaka
Tel
072-683-1221
rinri@art.osaka-med.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
大阪医科大学（大阪府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 22 | Day |
Related information
URL releasing protocol
Preoperative evaluation of the vitreous body using ultrasound elastography
Publication of results
Partially published
Result
URL related to results and publications
Preoperative evaluation of the vitreous body using ultrasound elastography
Number of participants that the trial has enrolled
107
Results
We evaluated the elasticity of the vitreous using preoperative ultrasound elastography
for various vitreoretinal diseases such as
idiopathic epiretinal membrane, idiopathic
macular hole, rhegmatogenous retinal
detachment, and diabetic retinopathy. In
cases with bursa premacularis, the vitreous in front of the macula was found to be high elasticity.
Results date posted
| 2021 | Year | 07 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 04 | Month | 15 | Day |
Baseline Characteristics
Patients with vitreoretinal diseases that
required vitreoretinal surgery
Participant flow
Preoperative examination
Adverse events
None
Outcome measures
Evaluation of the elasticity of the vitreous body using ultrasound elastography
Plan to share IPD
No specific plans
IPD sharing Plan description
Already reported at the 125th Japanese
Society of Ophthalmology, and plan to write an original paper in the near future.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 10 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 01 | Month | 22 | Day |
Last modified on
| 2021 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044731
