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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031895
Receipt No. 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

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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
Email 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
Email y-okamoto@md.tsukuba.ac.jp

Sponsor
Institute Department of Ophthalmology, Faculty of Medicine, University of Tsukuba
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029272

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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