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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000044268
Receipt No. 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

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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
Email 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
Email zavide96@gmail.com

Sponsor
Institute Kitasato university Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050557

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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