UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009861 |
|---|---|
| Receipt number | R000011557 |
| Scientific Title | Assesment of change in subfoveal choroidal thickness after ophthalmic surgery |
| Date of disclosure of the study information | 2013/01/25 |
| Last modified on | 2023/01/15 18:26:00 |
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Basic information
Public title
Assesment of change in subfoveal choroidal thickness after ophthalmic surgery
Acronym
Assesment of change in subfoveal choroidal thickness after ophthalmic surgery
Scientific Title
Assesment of change in subfoveal choroidal thickness after ophthalmic surgery
Scientific Title:Acronym
Assesment of change in subfoveal choroidal thickness after ophthalmic surgery
Region
| Japan |
Condition
Condition
Participants who undergo ophthalmic surgery
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the time-dependent change of choroidal thickness using optical coherence tomography after ophthalmic surgery.
Basic objectives2
Others
Basic objectives -Others
Impact of choroidal thickness due to differences in surgical technique such as cataract surgery or vitrectomy.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of subfoveal choroidal thickness between at the time before ophthalmic surgery, 1 week and 4 week after surgery.
Key secondary outcomes
Impact of choroidal thickness due to differences in surgical technique.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eye have ophthalmic disease and meet the indication criteria of ophthalmic surgery in our hospital.
Over 20 year old
Key exclusion criteria
Cases clear OCT images can not be obtained
Patients with any of serious heart disease, cerebrovascular disease,blood disorder, renal failure, malignant tumor, systemic steroids.
History of ophthalmic surgery
Eyes with known a history of glaucoma,optic nerve atrophy.
High myopia -6D<
Eyes with active proliferative eye diseases.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taiji Sakamoto |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Ophthalmology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima JAPAN
TEL
099-275-5402
shou@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taiji Sakamoto |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Ophthalmology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima JAPAN
TEL
099-275-5402
Homepage URL
tsakamoto@m3.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Graduate School of Medical and Dental Sciences
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
Address
Tel
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
鹿児島大学病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 25 | 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
Tests
Optical coherence tomography
Visual acuity
Intraocular pressure
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
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subfoveal choroidal thickness using optical coherence tomography
Visual acuity
Intraocular pressure
Management information
Registered date
| 2013 | Year | 01 | Month | 24 | Day |
Last modified on
| 2023 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011557
