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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030285
Receipt No. R000034590
Scientific Title Posterior Chamber Phakic Intraocular Lens Implantation in Eyes with Low Anterior Chamber Depth. A Multicenter Study.
Date of disclosure of the study information 2017/12/06
Last modified on 2017/12/06

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Basic information
Public title Posterior Chamber Phakic Intraocular Lens Implantation in Eyes with Low Anterior Chamber Depth. A Multicenter Study.
Acronym Phakic Intraocular Lens Implantation in Eyes with Low Anterior Chamber Depth.
Scientific Title Posterior Chamber Phakic Intraocular Lens Implantation in Eyes with Low Anterior Chamber Depth. A Multicenter Study.
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazutaka Kamiya
Organization Kitasato University
Division name School of Allied Health
Zip code
Address 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL 0427788464
Email kamiyak-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazutaka Kamiya
Organization Kitasato University, School of Allied Health
Division name Visual Physiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Completed
Date of protocol fixation
2016 Year 01 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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