UMIN-CTR Clinical Trial

Basic information
Public title	Electrolysis for granular corneal dystrophy
Acronym	Electrolysis for corneal dystrophy
Scientific Title	Electrolysis for granular corneal dystrophy
Scientific Title:Acronym	Electrolysis for corneal dystrophy
Region	Japan

Condition
Condition	granular corneal dystrophy
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the efficacy of electrolysis for granular corneal dystrophy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sex, age, visual acuity, refraction, corneal thickness, slit-lamp microscopy, anterior segment optical coherence tomography
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who had electrolysis for granular corneal dystrophy from April 2021 to February 2022
Key exclusion criteria	NA
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Yuichi Middle name Last name Hori
Organization	Toho University, Omori medical center
Division name	Ophthalmology
Zip code	143-8541
Address	6-11-1, Omorinishi, Ota-ku, Tokyo
TEL	0337624151
Email	yhori@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Yuichi Middle name Last name Hori
Organization	Toho University, Omori medical center
Division name	Ophthalmology
Zip code	143-8541
Address	6-11-1, Omorinishi, Ota-ku, Tokyo
TEL	0337624151
Homepage URL
Email	yhori@med.toho-u.ac.jp

Sponsor
Institute	Toho University, Omori medical center
Institute
Department

Funding Source
Organization	Toho University, Omori medical center
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	Ethics Committee of Toho University Omori Medical Center
Address	6-11-1, Omorinishi, Ota-ku, Tokyo
Tel	03-5763-6534
Email	omori.rinri@ext.toho-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

Other administrative information
Date of disclosure of the study information	2022 Year 03 Month 22 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	14
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	No longer recruiting
Date of protocol fixation	2021 Year 04 Month 01 Day
Date of IRB	2022 Year 02 Month 22 Day
Anticipated trial start date	2021 Year 04 Month 01 Day
Last follow-up date	2022 Year 02 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2023 Year 03 Month 31 Day

Other
Other related information	Retrospective study

Management information
Registered date	2022 Year 03 Month 22 Day
Last modified on	2022 Year 03 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053892