UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031895 |
|---|---|
| Receipt number | R000029272 |
| Scientific Title | The change of ocular biometry in ophthalmic patients who received anti-VEGF therapy |
| Date of disclosure of the study information | 2018/03/26 |
| Last modified on | 2019/03/27 12:42:43 |
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Basic information
Public title
The change of ocular biometry in ophthalmic patients who received anti-VEGF therapy
Acronym
The change of ocular biometry in ophthalmic patients who received anti-VEGF therapy
Scientific Title
The change of ocular biometry in ophthalmic patients who received anti-VEGF therapy
Scientific Title:Acronym
The change of ocular biometry in ophthalmic patients who received anti-VEGF therapy
Region
| Japan |
Condition
Condition
Patients with vitreoretinal diseases who need anti-VEGF therapy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the change of retinal form and visual function who received anti-VEGF therapy in patients with various disorders such as vitreomacular disease, retinal ischemic disease, and retinal neovascularization.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
axial length, degree of crystalline lens opacity, functional visual acuity, contrast sensitivity, stereoscopic vision, metamorphopsia, color vision, microperimetry, retinal form, corneal biometry, VFQ-25
Key secondary outcomes
visual acuity, intraocular pressure, frequency and degree of anti-VEGF injection complex
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
anterior segment biometry (CASIA, TMS-5), axial length, stereoscopic vision, metamorphopsia, contrast sensitivity, visual acuity, intraocular pressure, frequency and degree of complex, degree of crystalline lens opacity, retinal form, microperimetry, VFQ-25 questionnaire
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with retinal diseases who need anti-VEGF therapy
Key exclusion criteria
Patients ruled unfit to the study by investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Okamoto |
Organization
University of Tsukuba
Division name
Department of Ophthalmology, Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba-city, Ibaraki
TEL
0298533148
y-okamoto@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Okamoto |
Organization
University of Tsukuba
Division name
Department of Ophthalmology, Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba-city, Ibaraki
TEL
0298533148
Homepage URL
y-okamoto@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Faculty of Medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Faculty of Medicine, University of Tsukuba
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Ophthalmology, Mito Kyodo General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennoudai, Tsukuba-city, Ibaraki
Tel
0298533525
y-okamoto@md.tsukuba.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 | 03 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 26 | Day |
Last modified on
| 2019 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029272
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
