UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Microtube-assisted intrascleral intraocular lens fixation
Title of the study (Brief title)	Microtube-assisted intrascleral intraocular lens fixation
Region	Japan

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

Objectives
Narrative objectives1	Assessing the utility of the microtube-assissed intrascleral injtraocular lens fixation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	stability of the intraocular lens, best-corrected visual acuity, corneal endothelial cell density, complication
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	operation Intrascleral intraocular lens fixation
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	Patients with apakia who need intrascleral intraocular lens fixation
Key exclusion criteria	none
Target sample size	50

Research contact person
Name of lead principal investigator	Kentaro Yuda
Organization	Yokohama minami kyousai hospital
Division name	department of ophthalmology
Address	1-21-1 Mutsuurahigashi, Kanazawaku, Yokohamashi, Kanagawaken
TEL	045-782-2101
Email	kyuda6482@yahoo.co.jp

Public contact
Name of contact person	Kentaro Yuda
Organization	Yokohama minami kyousai hospital
Division name	Department of ophthalmology
Address	1-21-1 Mutsuurahigashi, Kanazawaku, Yokohamashi, Kanagawaken
TEL	045-782-2101
Homepage URL
Email	kyuda6482@yahoo.co.jp

Sponsor
Institute	Yokohama minami kyousai hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 09 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 08 Month 01 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 30 Day
Last modified on	2017 Year 08 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033069