UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Posterior Chamber Phakic Intraocular Lens Implantation in Eyes with Low Anterior Chamber Depth. A Multicenter Study.
Title of the study (Brief title)	Phakic Intraocular Lens Implantation in Eyes with Low Anterior Chamber Depth.
Region	Japan

Condition
Condition	Myopia and myopic astigmatism
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the clinical outcomes of Visian ICL (STAAR Surgical, Inc.) implantation for the correction of myopic refractive errors in eyes having low anterior chamber depth.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual acuity, Refraction, Enodothelial cell density, Adverse events
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Visual acuity, refraction, slit-lamp examination
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	55 years-old >=
Gender	Male
Key inclusion criteria	unsatisfactory correction with spectacles or contact lenses after cataract surgery, 20 to age to 55 years, stable refraction for at least 1 month, anterior chamber depth (measured from the corneal endothelium)less than 2.8 mm, endothelial cell density 1500 cells/mm2 or more
Key exclusion criteria	no history of keratoconus, progressive corneal degeneration, glaucoma or uveitis.
Target sample size	300

Research contact person
Name of lead principal investigator	Kazutaka Kamiya
Organization	Kitasato University
Division name	School of Allied Health
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL	0427788464
Email	kamiyak-tky@umin.ac.jp

Public contact
Name of contact person	Kazutaka Kamiya
Organization	Kitasato University, School of Allied Health
Division name	Visual Physiology
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL	0427788464
Homepage URL
Email	kamiyak-tky@umin.ac.jp

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	Kitasato University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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 12 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 01 Day
Anticipated trial start date	2016 Year 01 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 12 Month 06 Day
Last modified on	2017 Year 12 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034590