UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030285 |
|---|---|
| Receipt number | 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 14:42:44 |
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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
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
kamiyak-tky@umin.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034590
