UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Silicone microtube assisted scleral fixation of a posterior chamber intraocular lens
Title of the study (Brief title)	Posterior chamber IOL scleral fixation
Region	Japan

Condition
Condition	Aphakia, IOL dislocation, IOL opacity
Classification by specialty	Ophthalmology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety of scleral fixation of IOL assisted by a flexible slicone microtube which does not require the difficult intraocular procedure and does not damage the IOL or eye tissue.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Visual acuity (post operation:1 week, 1 month, 3 months, 6 months, and 1 year)
Key secondary outcomes	Intraocular pressure, refractive error, ophthalmoscopy, slit-lamp biomicroscopy (post operation:1 week, 1 month, 3 months, 6 months, and 1 year)

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	IOL scleral fixation using a silicone microtube is performed on the subjects.
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	Planned patients for IOL scleral fixation
Key exclusion criteria	none
Target sample size	10

Research contact person
Name of lead principal investigator	Motohiro Kamei
Organization	Aichi Medical University
Division name	Department of Ophthalmology
Address	1-1 KarimataYazako, Nagakute, Aichi, 480-1195 JAPAN
TEL	0561-62-3311
Email	motokamei@aichi-med-u.ac.jp

Public contact
Name of contact person	Takuya Kataoka
Organization	Aichi Medical University
Division name	Department of Ophthalmology
Address	1-1 KarimataYazako, Nagakute, Aichi, 480-1195 JAPAN
TEL	0561-62-3311
Homepage URL
Email	kataoka.takuya.401@mail.aichi-med-u.ac.jp

Sponsor
Institute	Aichi Medical University Department of Ohthalmology
Institute
Department

Funding Source
Organization	Aichi Medical University
Organization
Division
Category of Funding Organization	Self funding
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	愛知医科大学病院（愛知県）

Other administrative information
Date of disclosure of the study information	2022 Year 09 Month 30 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 16 Day
Anticipated trial start date	2017 Year 10 Month 17 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 10 Month 25 Day
Last modified on	2017 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033940