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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025883
Receipt No. 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

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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
Email 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
Email yoshio.hirano@gmail.com

Sponsor
Institute Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029749

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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