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

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 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


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

Value
https://center6.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