UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047757 |
|---|---|
| Receipt number | R000054446 |
| Scientific Title | Exploration of visual function evaluation methods and clinical endpoints in patients with ultra-low vision |
| Date of disclosure of the study information | 2022/05/16 |
| Last modified on | 2022/10/26 11:13:13 |
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Basic information
Public title
Exploration of visual function evaluation methods and clinical endpoints in patients with ultra-low vision
Acronym
Exploration of visual function evaluation methods and clinical endpoints in patients with ultra-low vision
Scientific Title
Exploration of visual function evaluation methods and clinical endpoints in patients with ultra-low vision
Scientific Title:Acronym
Exploration of visual function evaluation methods and clinical endpoints in patients with ultra-low vision
Region
| Japan |
Condition
Condition
Inherited Retinal Disease: IRD
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploration of visual function assessment indices for patients with very low visual acuity.
Basic objectives2
Others
Basic objectives -Others
Exploration of visual function assessment indices for patients with very low visual acuity.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
-Full-field retinal sensitivity to light by full-field stimulus threshold (FST) testing
Key secondary outcomes
-Slit-lamp microscopy
-Visual acuity test
-Visual field test
-Fundus photography
-Fundus autofluorescence
-OCT
-ERG
-Visual evoked potential
-Electrically evoked response
-Mobility test
-ADL test
-Questionnaire regarding QOL
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[Inclusion Criteria for IRD Subject]
-Age: Men and women who are at least 20 years old at the time of obtaining consent.
-Patients diagnosed with IRD (depending on phenotype).
-At the time of obtaining consent, visual acuity of the worse eye is less than or equal to the counting finger (i.e. no light perception, light perception, hand motion, and counting finger)
[Inclusion Criteria for Healthy Subject]
-Age: Men and women who are at least 20 years old at the time of obtaining consent.
-Those who have no severe refractive error (severe refractive error: spherical equivalent -6D and less or +5D and more)
-Best-corrected visual acuity (decimal) 1.0 or better of both eyes at the time of obtaining consent.
Key exclusion criteria
1. Healthy people with other eye complications that significantly affect visual field or visual acuity, and with abnormal findings detected by slit-lamp microscopy, fundoscopy, OCT.
2. Those who underwent eye surgery within 3 months.
3. Subjects who have with a history of allergy to the agents to be used in this study, e.g. mydriatic agent, anesthetic agent, etc.
4. Subjects who are diagnosed with dementia or mental illness.
5. Those who are pregnant or lactating.
6. Those who are currently participating in other clinical trials.
7. Those who have participated in a clinical trial for therapeutic purposes within the past 3 months.
8. Those who with a history or suspected or confirmed diagnosis of alcohol or other drug addictions.
9. Those who unable to understand the evaluation and examination procedures.
10. Those who, in the judgment of the principal investigator, are considered to be at risk of becoming ineligible for the study.
11. Those who are judged by the principal investigator or other investigators to be inappropriate for participation in this study.
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | Kazuno |
| Middle name | |
| Last name | Negishi |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi Shinjyuku-ku Tokyo, Japan
TEL
03-5843-6993
kazunonegishi@keio.jp
Public contact
Name of contact person
| 1st name | Toshihide |
| Middle name | |
| Last name | Kurihara |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi Shinjyuku-ku Tokyo, Japan
TEL
070-4921-5196
Homepage URL
kurihara@z8.keio.jp
Sponsor or person
Institute
Keio University school of Medicine
Institute
Department
Personal name
Funding Source
Organization
Restore Vision Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi Shinjyuku-ku Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
慶應義塾大学医学部
Keio University School of Medicine
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Exploration of visual function assessment indices for patients with very low visual acuity.
Management information
Registered date
| 2022 | Year | 05 | Month | 14 | Day |
Last modified on
| 2022 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054446
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