UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033960 |
|---|---|
| Receipt number | R000038720 |
| Scientific Title | The photopic negative response in glaucoma and non-glaucoma: Effects of new stimulus conditions. |
| Date of disclosure of the study information | 2021/03/31 |
| Last modified on | 2023/10/14 13:19:27 |
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Basic information
Public title
The photopic negative response in glaucoma and non-glaucoma: Effects of new stimulus conditions.
Acronym
The photopic negative response in glaucoma and non-glaucoma: Effects of new stimulus conditions.
Scientific Title
The photopic negative response in glaucoma and non-glaucoma: Effects of new stimulus conditions.
Scientific Title:Acronym
The photopic negative response in glaucoma and non-glaucoma: Effects of new stimulus conditions.
Region
| Japan |
Condition
Condition
open angle glaucoma and non-glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the relationship between the morphology and function in the macular region of eyes with open angle glaucoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
electroretinogram
Key secondary outcomes
visual field
optical coherence tomography study
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
| Device,equipment |
Interventions/Control_1
Objects: The diagnosis of OAG was based on the presence of normal open angle and glaucomatous optic disc corresponding to glaucomatous visual field defect.
The inclusion criteria were as follows: a best-corrected visual acuity is more than 1.0. Exclusion criteria were as follows: intraocular abnormalities other than glaucoma,history of ocular surgeries including laser therapy.
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.The patient who was enough explained and understand this study.
2.The patient who agree this study by the free will and sign consent forms.
3.The patient who was diagnosed adjuvant is appropriate.
Key exclusion criteria
The patient who judged adjuvant is inappropriate by principal investigator or member of a research project.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kiyofumi |
| Middle name | |
| Last name | Mochizuki |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
501-1194
Address
1-1 Yanagido, Gifu-shi, Gifu
TEL
0582306283
mochi-gif@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kiyofumi |
| Middle name | |
| Last name | Mochizuki |
Organization
Gifu University
Division name
Department of Ophthalmology
Zip code
501-1194
Address
1-1 Yanagido, Gifu-shi, Gifu
TEL
0582306283
Homepage URL
mochi-gif@umin.ac.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine
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
Gifu University Graduate School of Medicine Research Support Section
Address
1-1 Yanagido, Gifu-shi, Gifu
Tel
058-230-6059
rinri@gifu-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
ツカザキ病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
Results
This study has been terminated due to difficulties in enrolling new patients as a result of the coronavirus pandemic.
Results date posted
| 2023 | Year | 10 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
none
Participant flow
none
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study has been terminated due to difficulties in enrolling new patients as a result of the coronavirus pandemic.
Management information
Registered date
| 2018 | Year | 08 | Month | 30 | Day |
Last modified on
| 2023 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038720
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
