UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025883 |
|---|---|
| Receipt number | R000029749 |
| Scientific Title | Evaluation of relationship between retinal sensitivity in nonperfused areas and macular edema in eyes with retinal vein occlusion (RVO) |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2017/01/27 16:57:27 |
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Basic information
Public title
Evaluation of relationship between retinal sensitivity in nonperfused areas and macular edema in eyes with retinal vein occlusion (RVO)
Acronym
Retinal sensitivity and macular edema in retinal vein occlusion
Scientific Title
Evaluation of relationship between retinal sensitivity in nonperfused areas and macular edema in eyes with retinal vein occlusion (RVO)
Scientific Title:Acronym
Retinal sensitivity and macular edema in retinal vein occlusion
Region
| Japan |
Condition
Condition
Retinal Vein Occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the retinal sensitivity in nonperfused areas and evaluate whether the retinal sensitivity is related to macular edema, microaneurysms formation, and retinal thickness in eyes with retinal vein occlusion.
Basic objectives2
Others
Basic objectives -Others
Confirmatory
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Retinal sensitivity, macular edema, microaneurysms formation, and retinal thickness
Key secondary outcomes
Best-corrected visual acuity
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
1.RVO eyes with nonperfused areas
2.Japanese patients
3.Patients considered as eligible for stu
dy by the investigator
Key exclusion criteria
1.Patients whose images were too poor quality to be analyzed, who had thick retinal hemorrhage or severe macular edema
2.Presence of other macular diseases
3.High myopia -6.0 diopter (D) or worse
4.Patients judged by the investigator to be ineligible for other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Hirano |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL
052-853-8251
yoshio.hirano@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Hirano |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL
052-853-8251
Homepage URL
yoshio.hirano@gmail.com
Sponsor or person
Institute
Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 01 | 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
Retinal sensitivity in NPAs was positively correlated with the thickness of outer retina, macular edema, and microaneurysms formation
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
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 03 | Month | 01 | Day |
Other
Other related information
The mean retinal sensitivity at all of the 33 points was positively correlated with the visual acuity. In the NPAs, the retinal sensitivity was significantly decreased compared with that in the perfused area, negatively correlated with a duration after disease onset, and positively correlated with the outer retinal thickness, macular edema, and microaneurysms formation. The retinal sensitivity at the edgeo of NPAs was significantly higher than that of the other groups. Also, microaneurysms were significantly more frequently detected in the B group, but macular edema was not so.
Management information
Registered date
| 2017 | Year | 01 | Month | 27 | Day |
Last modified on
| 2017 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029749
