UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of relationship between retinal sensitivity in nonperfused areas and macular edema in eyes with retinal vein occlusion (RVO)
Title of the study (Brief title)	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	Yoshio Hirano
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Ophthalmology and Visual Science
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	Yoshio Hirano
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Ophthalmology and Visual Science
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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Retinal sensitivity in NPAs was positively correlated with the thickness of outer retina, macular edema, and microaneurysms formation
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