UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018771 |
|---|---|
| Receipt number | 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 12:20:58 |
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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
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
kamiyak-tky@umin.ac.jp
Sponsor or person
Institute
University of Kitasato School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021715
