UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000057933 |
|---|---|
| Receipt number | R000066232 |
| Scientific Title | Investigation of the Effect of Pupil Area on Electroretinogram Recordings Under Dark Adaptation |
| Date of disclosure of the study information | 2025/06/30 |
| Last modified on | 2025/05/21 20:23:49 |
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Basic information
Public title
Investigation of the Effect of Pupil Area on Electroretinogram Recordings Under Dark Adaptation Conditions
Acronym
Mesopic ERG
Scientific Title
Investigation of the Effect of Pupil Area on Electroretinogram Recordings Under Dark Adaptation
Scientific Title:Acronym
Mesopic ERG Study
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of changes in pupil area on electroretinogram (ERG) recordings under dark-adapted conditions.
Basic objectives2
Others
Basic objectives -Others
To deliver light stimuli under Td (Troland) conditions while varying the pupil area, record electroretinograms (ERGs) under dark-adapted conditions, and analyze whether the results vary depending on pupil diameter.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in implicit time and amplitude of rod response under dark-adapted conditions
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
The subject will instill pilocarpine eye drops twice at five-minute intervals.
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults without ocular disease
Aged 18 years or older
Able to provide written informed consent after receiving an explanation of the study
Key exclusion criteria
History of hypersensitivity to pilocarpine eye drops
Use of a cardiac pacemaker
History or suspected history of epilepsy
Presence of bronchial asthma
Pregnant or breastfeeding individuals
Judged as inappropriate for participation by the principal or sub-investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Kato |
Organization
Mir University
Division name
Ophthalmology
Zip code
514-8507
Address
2-174, Edobashi, Tsu-shi, Mie
TEL
059-232-1111
k-kato@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Kato |
Organization
Mie University
Division name
Ophthalmology
Zip code
514-8507
Address
2-174, Edobashi, Tsu-shi, Mie
TEL
0592311111
Homepage URL
k-kato@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Mie University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board (IRB), Mie University Hospital
Address
2-174 Edobashi, Tsu City, Mie 514-8507, Japan
Tel
0592311111
kk-sien@med.mie-u.ac.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
| 2025 | Year | 06 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2025 | Year | 05 | Month | 21 | Day |
Last modified on
| 2025 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066232
