UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of clinical outcomes between ICL KS-AquaPORT V5 and conventional V4 model
Title of the study (Brief title)	Comparison between ICL V5 and V4 model
Region	Japan

Condition
Condition	myopia and myopic astigmatism
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of efficacy and safety
Basic objectives2	Others
Basic objectives -Others	Subjective visual symptoms after surgery
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	uncorrected visual acuity, corrected visual acuity, intraocular pressure
Key secondary outcomes	questionnaire about vision after surgery

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Surgery using ICL V4 model is performed in one eye.
Interventions/Control_2	Surgery using ICL V5 model is performed in the other eye.
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	45 years-old >=
Gender	Male and Female
Key inclusion criteria	myopia or myopic astigmatism
Key exclusion criteria	Glaucoma Diabetic retinopathy Inflammatory ocular disease including uveitis pregnant woman
Target sample size	20

Research contact person
Name of lead principal investigator	Takashi Kojima
Organization	Nagoya Eye Clinic
Division name	Ophthalmology
Address	25-1 Namiyose-cho, Atsuta-ku, Nagoya, Aichi, Japan
TEL	0120-758-049
Email	tkojkoj@mac.com

Public contact
Name of contact person	Junko Sawada
Organization	Ophthalmology
Division name	Executive department
Address	25-1 Namiyose-cho, Atsuta-ku, Nagoya, Aichi, Japan
TEL	0120-758-049
Homepage URL
Email	sawada@lasik.jp

Sponsor
Institute	Nagoya Eye Clinic
Institute
Department

Funding Source
Organization	Self-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	北里大学 眼科学教室（神奈川県）、 神戸神奈川アイクリニック（東京）、 名古屋アイクリニック（愛知県）、 山王病院 眼科（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 29 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 04 Month 26 Day
Last modified on	2018 Year 04 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036767