UMIN-CTR Clinical Trial

Basic information
Public title	Remote visual ADL investigation for retinitis pigmentosa
Acronym	Re-RP LVFAM prototype
Scientific Title	Remote visual ADL investigation for retinitis pigmentosa
Scientific Title:Acronym	Re-RP LVFAM prototype
Region	Japan

Condition
Condition	retinitis pigmentosa
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Tolerability study of the new LVFAM, a modified version of the Visual ADL Questionnaire (LVFAM) for retinitis pigmentosa (RP) and remote use.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Tolerability Checklist
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Retinitis pigmentosa patients in the outpatient clinic of Chiba University Department of Ophthalmology 2) Visited between January 1, 2022 and September 30, 2022 3) History of Humphrey Field of View (HFA) 10-2 measurements 4) Corrected visual acuity in both eyes in the range of 0.2 to 0.9
Key exclusion criteria	(1) 20 years of age or older and less than 80 years of age (3) Patients with other ophthalmologic diseases that affect visual function 4) Cases of blindness in one eye (5) Cases with significant fluctuations in visual function and findings
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Sugawara
Organization	Chiba University Hpspital
Division name	Ophthalmology
Zip code	260-8677
Address	Chiba City, Chuo-ku, Inohana 1-8-1
TEL	0432227171
Email	takeshis@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Takeshi Middle name Last name Sugawara
Organization	Chiba University Hospital
Division name	Ophthalmology
Zip code	260-8677
Address	Chiba City, Chuo-ku, Inohana 1-8-1
TEL	0432227171
Homepage URL
Email	takeshis@faculty.chiba-u.jp

Sponsor
Institute	Chiba University Hospital
Institute
Department

Funding Source
Organization	MEXT
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	Chiba University Hospital
Address	Chiba City, Chuo-ku, Inohana 1-8-1
Tel	0432227171
Email	takeshis@faculty.chiba-u.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 04 Month 11 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	Completed
Date of protocol fixation	2022 Year 02 Month 09 Day
Date of IRB	2022 Year 04 Month 01 Day
Anticipated trial start date	2022 Year 04 Month 11 Day
Last follow-up date	2022 Year 08 Month 09 Day
Date of closure to data entry	2022 Year 08 Month 10 Day
Date trial data considered complete	2022 Year 09 Month 12 Day
Date analysis concluded	2022 Year 09 Month 12 Day

Other
Other related information	questionnaire survey

Management information
Registered date	2022 Year 04 Month 11 Day
Last modified on	2022 Year 09 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054115