UMIN-CTR Clinical Trial

Basic information
Public title	The relationship between vision and macular sensitivity in both retinitis pigmentosa and glaucoma patients
Acronym	Macular sensitivity in retinitis pigmentosa
Scientific Title	Macular sensitivity in retinitis pigmentosa
Scientific Title:Acronym	Macular sensitivity in retinitis pigmentosa
Region	Japan

Condition
Condition	Retinitis Pigmentosa
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	preliminary study for macular sensitivity
Basic objectives2	Others
Basic objectives -Others	retrospective study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationship between macular sensitivity and vision
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	20200401-20210331,in the Chiba University Hospital or Ohami eye clinic, Retinitis pigmentosa or Glaucoma, HFA10-2, vision 0.2-0.9
Key exclusion criteria	without other eye diseases, last eye, fluctuation; variation
Target sample size	30

Research contact person
Name of lead principal investigator	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	043-222-7171
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	NON
Organization
Division
Category of Funding Organization	Other
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	prc-jim@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	2021 Year 09 Month 01 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	2021 Year 08 Month 02 Day
Date of IRB	2021 Year 07 Month 01 Day
Anticipated trial start date	2021 Year 09 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	retrospective study

Management information
Registered date	2021 Year 08 Month 24 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=R000051678