UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045089 |
|---|---|
| Receipt number | R000051489 |
| Scientific Title | A Multicenter Study on 1-Year Outcomes of Posterior Chamber Phakic Intraocular Lens Implantation for Low Myopia. |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2025/04/17 11:52:43 |
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Basic information
Public title
A Multicenter Study on 1-Year Outcomes of Posterior Chamber Phakic Intraocular Lens Implantation for Low Myopia.
Acronym
Posterior Chamber Phakic Intraocular Lens Implantation for Low Myopia.
Scientific Title
A Multicenter Study on 1-Year Outcomes of Posterior Chamber Phakic Intraocular Lens Implantation for Low Myopia.
Scientific Title:Acronym
Posterior Chamber Phakic Intraocular Lens Implantation for Low Myopia.
Region
| Japan |
Condition
Condition
Low Myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the multicenter outcomes of posterior chamber phakic intraocular lens implantation with a central hole (hole ICL, STAAR Surgical) for a low grade of myopia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
unsatisfactory correction with spectacles or contact lenses, stable refraction, astigmatism of 3 D or less, anterior chamber depth 2.8 mm or more, and endothelial cell density (ECD) 1800 cells/mm2 or more.
Key exclusion criteria
history of ocular surgery, corneal diseases, including keratoconus and pellucid marginal degeneration, cataract, glaucoma, uveitis, other concomitant eye diseases.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kamiya |
| Middle name | Kazutaka |
| Last name | Kazutaka |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
2520373
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL
0427788464
kamiyak-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kazutaka |
| Middle name | |
| Last name | Kamiya |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
2520373
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
Kitasato University
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
Tel
0427788464
kamiyak-tky@umin.ac.jp
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
| 2022 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.frontiersin.org/articles/10.3389/fmed.2022.762153/full
Publication of results
Partially published
Result
URL related to results and publications
https://www.frontiersin.org/articles/10.3389/fmed.2022.762153/full
Number of participants that the trial has enrolled
172
Results
Uncorrected and corrected visual acuities were -0.17 0.12 and -0.24 0.07 logMAR at 1 year postoperatively. At 1 year postoperatively, 91% and 100% of eyes were within 0.5 and 1.0 D, respectively, of the targeted correction. No significant manifest refraction changes of -0.07 0.26 D occurred from 1 week to 1 year.
Results date posted
| 2022 | Year | 08 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
172 eyes of 111 consecutive patients undergoing hole ICL implantation to correct low myopia and myopic astigmatism
Participant flow
Retrospective observational study
Adverse events
None
Outcome measures
safety, efficacy, predictability, and safety
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Preoperatively, and 1 week, and 1, 3, 6, and 12 months postoperatively, and at the last visit, we determined the following metrics: the logarithm of the minimal angle of resolution (logMAR) of uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA), the MSE, the intraocular pressure (IOP) using a non-contact tonometer, and the ECD (preoperatively and 1 year postoperatively) using a non-contact specular microscope
Management information
Registered date
| 2021 | Year | 08 | Month | 07 | Day |
Last modified on
| 2025 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051489
