UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046695 |
|---|---|
| Receipt number | 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 17:47:45 |
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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
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
eijin0314@gmail.com
Sponsor or person
Institute
National Hospital Organization Osaka National Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053231
