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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018771
Receipt No. R000021715
Scientific Title Long-term Comparison of Posterior Chamber Phakic Intraocular Lens with and without a Central Hole (Hole ICL and Conventional ICL) Implantation for Moderate to High Myopia and Myopic Astigmatism.
Date of disclosure of the study information 2015/08/23
Last modified on 2015/08/23

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Basic information
Public title Long-term Comparison of Posterior Chamber Phakic Intraocular Lens with and without a Central Hole (Hole ICL and Conventional ICL) Implantation for Moderate to High Myopia and Myopic Astigmatism.
Acronym Long-term Comparison of Hole ICL and Conventional ICL
Scientific Title Long-term Comparison of Posterior Chamber Phakic Intraocular Lens with and without a Central Hole (Hole ICL and Conventional ICL) Implantation for Moderate to High Myopia and Myopic Astigmatism.
Scientific Title:Acronym Long-term Comparison of Hole ICL and Conventional ICL
Region
Japan

Condition
Condition Moderate to High Myopia and Myopic Astigmatism.
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the long-term clinical outcomes of implantation of the posterior chamber phakic intraocular lens (Visian ICLTM, STAAR Surgical) with and without a central artificial hole for moderate to high ametropia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Before, 1, 3 and 6 months, and 1, 3, and 5 years after surgery, we assessed safety, efficacy, predictability, stability, intraocular pressure, lens density, and adverse events of the two surgical techniques.
Key secondary outcomes

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Posterior Chamber Phakic Intraocular Lens with a Central Hole
Interventions/Control_2 Posterior Chamber Phakic Intraocular Lens without a Central Hole
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
18 years-old <=
Age-upper limit
50 years-old >=
Gender Male and Female
Key inclusion criteria Moderate to high myopia (manifest spherical equivalent -4.00 diopter (D) or more)
Key exclusion criteria Eyes with keratoconus were excluded from the study by using the keratoconus screening test of Placido disk videokeratography.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimiya Shimizu
Organization University of Kitasato School of Medicine
Division name Department of Ophthalmology
Zip code
Address 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan.
TEL +81-42-778-8464
Email kimiyas@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazutaka Kamiya
Organization University of Kitasato School of Medicine
Division name Department of Ophthalmology
Zip code
Address 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan.
TEL +81-42-778-8464
Homepage URL
Email kamiyak-tky@umin.ac.jp

Sponsor
Institute University of Kitasato School of Medicine
Institute
Department

Funding Source
Organization This work was supported in part by Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology of Japan (24592642).
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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
2015 Year 08 Month 23 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
2010 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2010 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
2015 Year 08 Month 23 Day
Last modified on
2015 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021715

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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