UMIN-CTR Clinical Trial

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