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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047757
Receipt No. 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 2022/05/14

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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 40

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
Email 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
Email kurihara@z8.keio.jp

Sponsor
Institute Keio University school of Medicine
Institute
Department

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
Email 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 Preinitiation
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 05 Month 14 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054446

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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