UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006769
Receipt number R000008005
Scientific Title The relation between choroidal thickness and fundus blood flow in high myopia.
Date of disclosure of the study information 2011/11/26
Last modified on 2020/05/11 11:10:27

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Basic information

Public title

The relation between choroidal thickness and fundus blood flow in high myopia.

Acronym

The relation between choroidal thickness and fundus blood flow in high myopia.

Scientific Title

The relation between choroidal thickness and fundus blood flow in high myopia.

Scientific Title:Acronym

The relation between choroidal thickness and fundus blood flow in high myopia.

Region

Japan


Condition

Condition

High myopia

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the relationship between choroidal thickness and fundus blood flow in high myopia.

Basic objectives2

Others

Basic objectives -Others

The choroid in eyes with high myopia was found to be thinner than normal. The choroidal blood flow of the thin choroid is investigated with Laser
Speckle Flowgraphy(LSFG).

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Axial length, choroidal thickness and mean blur rate (MBR).

Key secondary outcomes



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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Highly myopic patients who are able to be measured spectral-domain optical coherence tomography and Laser Speckle Flowgraphy.

Key exclusion criteria

The exclusion criteria were the presence of macular diseases except for myopic change, glaucoma and severe cataract preventing detailed fundus observation in the study eye.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideharu Ohsugi

Organization

Saneikai Tsukazaki Hospital

Division name

Department of Ophthalmology

Zip code


Address

68-1, Waku, Aboshi-ku, Himeji, Hyogo Prefecture, Japan

TEL

079-272-8555

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hideharu Ohsugi

Organization

Saneikai Tsukazaki Hospital

Division name

Department of Ophthalmology

Zip code


Address

68-1, Waku, Aboshi-ku, Himeji, Hyogo Prefecture, Japan

TEL

079-272-8555

Homepage URL


Email

h.ohsugi@tsukazaki-eye.net


Sponsor or person

Institute

Saneikai Tsukazaki Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



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

2011 Year 11 Month 26 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


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

2011 Year 07 Month 15 Day

Date of IRB

2011 Year 07 Month 01 Day

Anticipated trial start date

2011 Year 07 Month 01 Day

Last follow-up date

2020 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To investigate the relationship between choroidal thickness and fundus blood flow in high myopia.
A prospective study of a consecutive sample of patients with high myopia.


Management information

Registered date

2011 Year 11 Month 25 Day

Last modified on

2020 Year 05 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008005


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name