UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of Cause and Prognosis in Eyes Requiring Implantable Collamer Lens Extraction.
Acronym	Cause and Prognosis in Eyes Requiring Implantable Collamer Lens Extraction.
Scientific Title	Evaluation of Cause and Prognosis in Eyes Requiring Implantable Collamer Lens Extraction.
Scientific Title:Acronym	Cause and Prognosis in Eyes Requiring Implantable Collamer Lens Extraction.
Region	Japan

Condition
Condition	myopia
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of Implantable Collamer Lens Extraction.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative visual acuity, refraction, endothelium, satisfaction
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	28 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	A case of ICL extraction surgery at Kitasato University Hospital
Key exclusion criteria	nothing
Target sample size	8

Research contact person
Name of lead principal investigator	1st name Syoji Middle name Last name Nobuyuki
Organization	Kitasato Univ Hospital
Division name	opthalmology
Zip code	252-0374
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL	0427788464
Email	m09088w@st.kitasato-u.ac.jp

Public contact
Name of contact person	1st name Hideki Middle name Last name Hayakawa
Organization	Kitasato Univ Hospital
Division name	opthalmology
Zip code	252-0374
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL	0427788464
Homepage URL
Email	m09088w@st.kitasato-u.ac.jp

Sponsor
Institute	Kitasato Univ Hospital
Institute
Department

Funding Source
Organization	nothing
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	Kitasato Univ Hospital
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
Tel	0427788464
Email	m09088w@st.kitasato-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	2020 Year 10 Month 15 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	7
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	Main results already published
Date of protocol fixation	2020 Year 04 Month 20 Day
Date of IRB	2020 Year 08 Month 21 Day
Anticipated trial start date	2020 Year 04 Month 20 Day
Last follow-up date	2020 Year 04 Month 20 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	2020 Year 05 Month 07 Day
Last modified on	2020 Year 11 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046011