UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046332 |
|---|---|
| Receipt number | R000052870 |
| Scientific Title | Clinical outocomes in eyes undergoing vertically fixated phakic intraocular lens implantation. |
| Date of disclosure of the study information | 2021/12/10 |
| Last modified on | 2023/06/30 16:00:35 |
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Basic information
Public title
Clinical outocomes in eyes undergoing vertically fixated phakic intraocular lens implantation.
Acronym
Clinical outocomes in eyes undergoing vertically fixated Visian ICL
Scientific Title
Clinical outocomes in eyes undergoing vertically fixated phakic intraocular lens implantation.
Scientific Title:Acronym
Clinical outocomes in eyes undergoing vertically fixated Visian ICL
Region
| Japan |
Condition
Condition
refractive error
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are only four different sizes of ICL , and there are cases in which there is no appropriate size for horizontal fixation.
In this study, we will examine the clinical results of a case in which a vertical fixation was used when it was difficult to obtain an appropriate vault with horizontal fixation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1-year postoperative vault values for patients who underwent ICL surgery
Key secondary outcomes
Comparison of visual function (visual acuity, refractive power, predictability, corneal endothelium, intraocular pressure, complications) preoperatively and at 1 week, 1 month, 3 months, and 1 year postoperatively.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have vertically fixed ICLs and have completed one year of postoperative care.
Key exclusion criteria
History of ocular diseases other than refractive error or other ophthalmic surgeries. Low reliability of biometric data from preoperative testing.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | kazutaka |
| Middle name | |
| Last name | kamiya |
Organization
Kitasato University Hospital
Division name
ophthalmology
Zip code
252-0375
Address
1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa
TEL
042-778-8111
kamiyak-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | wakako |
| Middle name | |
| Last name | ando |
Organization
Kitasato University Hospital
Division name
ophthalmology
Zip code
252-0375
Address
1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa
TEL
042-778-8111
Homepage URL
wakako@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Hospital Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Kitasato University Hospital Ophthalmology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Kitasato University School of Medicine and Hospital
Address
1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa
Tel
042-778-8111
rinrib@med.kitasato-u.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
| 2021 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
https://link.springer.com/content/pdf/10.1007/s40123-022-00470-6.pdf
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/content/pdf/10.1007/s40123-022-00470-6.pdf
Number of participants that the trial has enrolled
71
Results
At 1 year postoperatively, uncorrected visual acuity was -0.20 (logMAR) and corrected visual acuity was -0.25 (logMAR). The difference from the target refraction was within 0.5 D in 98 percent and within 1.00 D in 100 percent. Astigmatism decreased significantly from 0.69 D preoperatively to 0.21 D at 1 year postoperatively. There were no vision-threatening complications. Vertical fixation ICL can reduce astigmatism and provide good visual function.
Results date posted
| 2023 | Year | 06 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 71 eyes of 43 patients (20 men and 23 women: age 30.3 years) met the inclusion criteria of this study.
Participant flow
A total of 71 eyes of 43 patients (20 men and 23 women: age 30.3 years) met the inclusion criteria of this study.
Adverse events
None.
Outcome measures
Preoperatively, and 1 week and 1, 3, and 12 months postoperatively, we obtained the following parameters: the logarithm of the minimal angle of resolution (logMAR) of uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA), the manifest spherical equivalent, the manifest cylinder, the intraocular pressure (IOP) using a non-contact tonometer, the endothelial cell density (ECD; preoperatively and 3 months and 1 year postoperatively) using a non-contactspecular microscope, and the vault between theanterior surface of the crystalline lens and the posterior surface of the ICL using anterior segment optical coherence tomography (AS-OCT), in addition to routinely performed ophthalmic examinations. All available visit data were collected and grouped according to the closesttime point. If more than one visit was available within a given grouping, we used the visit data most comparable to the given time point for this analysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort Study.
Patients who had vertical fixation of ICL at the Department of Ophthalmology, Kitasato University Hospital from April 1, 2018 to September 30, 2020 and completed 1 year of postoperative care by September 30, 2021.
Management information
Registered date
| 2021 | Year | 12 | Month | 09 | Day |
Last modified on
| 2023 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052870
