UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025106 |
|---|---|
| Receipt number | R000028867 |
| Scientific Title | Study of retinal venous pressure measured by Contact Lens Dynamometer |
| Date of disclosure of the study information | 2016/12/06 |
| Last modified on | 2023/01/04 10:44:02 |
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Basic information
Public title
Study of retinal venous pressure measured by Contact Lens Dynamometer
Acronym
Study of retinal venous pressure measured by Contact Lens Dynamometer
Scientific Title
Study of retinal venous pressure measured by Contact Lens Dynamometer
Scientific Title:Acronym
Study of retinal venous pressure measured by Contact Lens Dynamometer
Region
| Japan |
Condition
Condition
vitreoretinal disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the pathogenesis of vitreoretinal diseses by measuring retinal venous pressure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood test and measurement of retinal venous pressure before and 1 month, 6 months after the treatment.
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
blood test and measurement of retinal venous pressure by using contact lens dynamometer before and 1 month, 6 months after the treatment
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with vitreoretinal diseases such as retinal vein occlusion, diabetic retinopathy, age-related macular degeneration, myopic choroidal neovascularlization.
Key exclusion criteria
patients who is difficult to be measured retinal venous pressure.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Teruyo |
| Middle name | |
| Last name | Kida |
Organization
Osaka Medical College
Division name
Ophthalmology
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki, 569-8686
TEL
072-683-1221
kida_teruyo@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Teruyo |
| Middle name | |
| Last name | Kida |
Organization
Osaka Medical College
Division name
Ophthalmology
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki, 569-8686
TEL
072-683-1221
Homepage URL
kida_teruyo@yahoo.co.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical College
Address
2-7 Daigaku-machi, Takatsuki, 569-8686
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 06 | Day |
Related information
URL releasing protocol
Graefes Arch Clin Exp Ophthalmol. 2021 Jul;259(7):1853-1858. doi: 10.1007/s00417-020-05068-x.
Publication of results
Published
Result
URL related to results and publications
Graefes Arch Clin Exp Ophthalmol. 2021 Jul;259(7):1853-1858. doi: 10.1007/s00417-020-05068-x.
Number of participants that the trial has enrolled
26
Results
Comparison of the BRVOs and CRVOs showed that VA was significantly improved by a single injection in BRVOs (P < 0.0001; P = 0.1087 for CRVOs), but CRT and RVP were significantly decreased without significant difference in IOP after the treatment in both groups (P < 0.0001).
Results date posted
| 2023 | Year | 01 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twenty-six patients with retinal vein occlusion (RVO)-related macular edema (16 branch RVOs [BRVOs] and 10 central RVOs [CRVOs], mean age 72.5 years) who visited our hospital were included.
Participant flow
Visual acuity (VA), intraocular pressure (IOP), central retinal thickness (CRT) determined by macular optical coherence tomography, and RVP measured using an ophthalmodynamometer were obtained before intravitreal injection of ranibizumab (IVR) and 1 month later.
Adverse events
none
Outcome measures
Visual acuity (VA), intraocular pressure (IOP), central retinal thickness (CRT), and retinal venous pressure (RVP)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 01 | Day |
Last modified on
| 2023 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028867
