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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000046695
Receipt No. R000053231
Scientific Title Examination of stimulation brightness of multi-focal ERG recording without mydriasis (under non-mydriasis)
Date of disclosure of the study information 2022/01/21
Last modified on 2022/01/21

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Basic information
Public title Examination of stimulation brightness of multi-focal ERG recording without mydriasis (under non-mydriasis)
Acronym Examination of stimulation brightness of multi-focal ERG recording without mydriasis (under non-mydriasis)
Scientific Title Examination of stimulation brightness of multi-focal ERG recording without mydriasis (under non-mydriasis)
Scientific Title:Acronym Examination of stimulation brightness of multi-focal ERG recording without mydriasis (under non-mydriasis)
Region
Japan

Condition
Condition Normal eye
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will examine the stimulus luminance for recording the same response as the conventional submydriatic mfERG under non-mydriasis.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes It was suggested that mfERG may be able to record the same response under mydriasis even under non-mydriasis by devising recording conditions. For the stimulation brightness under non-mydriasis, 1000 cd was considered to be the optimum intensity.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Measure 5 times under non-mydriasis and 1 time under mydriasis.
When measuring under mydriasis, instill only one drop of Tropicamide, Phenylephrine Hydrochloride into the measuring eye.
Before measuring all 6 times, apply only one drop of Oxybuprocaine Hydrochloride to both eyes and then record.
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
22 years-old <
Age-upper limit
61 years-old >=
Gender Male and Female
Key inclusion criteria Employees working at the Osaka Medical Center who are 20 years of age or older at the time of obtaining consent.
Those who have no history of eye diseases other than systemic diseases and refractive errors.
Key exclusion criteria Exclude those with a predisposition to increase intraocular pressure, such as glaucoma, narrow angle, and shallow anterior chamber.
Exclude those with a history of hypersensitivity to the components of the drugs used (Tropicamide, Phenylephrine Hydrochloride, Oxybuprocaine Hydrochloride ophthalmic solution) and benzoic acid ester-based local anesthetics.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Nakamura
Middle name
Last name Eiji
Organization National Hospital Organization Osaka National Hospital
Division name Ophthalmology
Zip code 5400006
Address 2-1-14 Hoenzaka, Chuo-ku, Osaka
TEL 0669421331
Email eijin0314@gmail.com

Public contact
Name of contact person
1st name Nakamura
Middle name
Last name Eiji
Organization National Hospital Organization Osaka National Hospital
Division name Ophthalmology
Zip code 5400006
Address 2-1-14 Hoenzaka, Chuo-ku, Osaka
TEL 0669421331
Homepage URL
Email eijin0314@gmail.com

Sponsor
Institute National Hospital Organization Osaka National Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization Osaka Medical Center Contract Research Review Committee Second Committee
Address 2-1-14 Hoenzaka, Chuo-ku, Osaka
Tel 0669421331
Email 408-chiken@mail.hosp.go.jp

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
2022 Year 01 Month 21 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 10
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
2020 Year 11 Month 09 Day
Date of IRB
2020 Year 11 Month 09 Day
Anticipated trial start date
2020 Year 11 Month 09 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 01 Month 21 Day
Last modified on
2022 Year 01 Month 21 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053231

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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