UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044268 |
|---|---|
| Receipt number | R000050557 |
| Scientific Title | Long-term clinical results of posterior chamber type intraocular lens with through hole |
| Date of disclosure of the study information | 2021/05/19 |
| Last modified on | 2021/05/19 17:34:05 |
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Basic information
Public title
Long-term clinical results of posterior chamber type intraocular lens with through hole
Acronym
Hole ICL long-term results
Scientific Title
Long-term clinical results of posterior chamber type intraocular lens with through hole
Scientific Title:Acronym
Hole ICL long-term results
Region
| Japan |
Condition
Condition
Refractive error
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We report the long-term postoperative results of a posterior tufted intraocular lens with a through hole (KS-AquaPORT, STAAR Surgical).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Naked eyes,corrected vision, safety, effectiveness, predictability, stability, eye pressure, corneal endothelial cell density, axial length, comorbidities
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
| 18 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Myopic astigmatism
Key exclusion criteria
none
Target sample size
206
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Shouji |
Organization
Kitasato university Hospital
Division name
Ophthalmogogy
Zip code
2520375
Address
1-15-1, Kitasato,Sagamihara-shi,Kanagawa
TEL
0427788111
zavide96@gmail.com
Public contact
Name of contact person
| 1st name | masahide |
| Middle name | |
| Last name | takahashi |
Organization
Kitasato university Hospital
Division name
Ophthalmogogy
Zip code
2520375
Address
1-15-1, Kitasato,Sagamihara-shi,Kanagawa
TEL
0427788111
Homepage URL
zavide96@gmail.com
Sponsor or person
Institute
Kitasato university Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato university
Address
1-15-1, Kitasato,Sagamihara-shi,Kanagawa
Tel
0427788111
zavide96@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
| 2021 | Year | 05 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
206
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
Main results already published
Date of protocol fixation
| 2020 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For myopic astigmatism, KS-AquaPORT was inserted at a related facility, and the long-term follow-up of 206 cases was 376 eyes (mean 35.0years, 93 males, 113 females). The preoperative equivalent sphere value was -7.86. Naked eye / corrected visual acuity, safety, efficacy, predictability, stability, intraocular pressure, corneal endothelial cell density, axial length, and complications were evaluated at 2, 4, 6 and 8 years after surgery.
Management information
Registered date
| 2021 | Year | 05 | Month | 19 | Day |
Last modified on
| 2021 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050557
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
