UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter comparative study of toric intraocular lens implantation using an image guide system
Acronym	Multicenter comparative study of toric intraocular lens implantation using an image guide system
Scientific Title	Multicenter comparative study of toric intraocular lens implantation using an image guide system
Scientific Title:Acronym	Multicenter comparative study of toric intraocular lens implantation using an image guide system
Region	Japan

Condition
Condition	cataract
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Toric intraocular lens used in cataract surgery can acquire good uncorrected visual acuity after surgery by correcting corneal astigmatism. In order to obtain good results in toric IOL implantation, accuracy of preoperative examination, toric model selection, control of induced astigmatism in surgery, and accurate implantation of IOL are important. In particular, toric IOL needs to be fixed to the astigmatic axis, and it it's off axis by 3 degrees, it loses about 3.3% of the refractive correction effect. Therefore, when the axis is shifted by 30 degrees, astigmatic correction effect is completely lost, and only the astigmatic axis may change. Conventionally, using a surgical pen, marking is performed at 0, 3, 6, 9 and 12 o'clock position with a slit lamp microscope before surgery, and fixed position is measured intraoperatively from that position, then toric IOL was implanted. The image guide system is a system that digitizes this technique and refers to anterior segment information photographed in a sitting position before surgery, and displays an accurate toric IOL fixation axis intraoperatively. Shortening of operation time, reduction of human error, and improvement of postoperative axis deviation can be expected. Currently, number of cases of toric IOL implantation are increasing, but until now it has been mostly studied in a single center, and less from multiple centers. The purpose of this study is to investigate prospectively the results after toric IOL implantation as a multi-institutional collaborative study, and to determine whether there is a difference between institutions.
Basic objectives2	Others
Basic objectives -Others	The purpose of this study is to evaluate prospective outcomes after toric IOL implantation as a multi-institutional cooperative study and evaluate postoperative outcomes.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative -visual acuity, subjective and objective refraction -corneal shape analysis by anterior segment OCT
Key secondary outcomes	Patients' background such as -age -sex -cataract nucleus hardness classification (Emery-Little classification) -disease type of cataract (WHO classification, nucleus, cortex, under posterior capsule) -preoperative visual acuity

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	Not applicable
Gender	Male and Female
Key inclusion criteria	-over 20 years old -does not have ocular disease other than cataract or refractive error -case without intraoperative complication
Key exclusion criteria	-being pregnant, lactating -brittle Zinn's zonule
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Kojima
Organization	Chukyo Eye Clinic
Division name	Chukyo Eye Clinic
Zip code	456-0032
Address	12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya, Aichi
TEL	052-883-1543
Email	kojima@chukyogroup.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Kojima
Organization	Chukyo Eye Clinic
Division name	Chukyo Eye Clinic
Zip code	456-0032
Address	12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya, Aichi
TEL	052-883-1543
Homepage URL
Email	kojima@chukyogroup.jp

Sponsor
Institute	Chukyo Eye Clinic
Institute
Department

Funding Source
Organization	none
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	Chukyo Medical IRB
Address	12-23 Sanbonmatsu-cho Atsuta-ku, Nagoya Aichi
Tel	052-884-7976
Email	irb@chukyomedical.co.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	医療法人いさな会 中京眼科(愛知県) 名古屋アイクリニック(愛知県) 医療法人桑友会 佐藤裕也眼科医院（宮城県） 岐阜赤十字病院（岐阜県） 医療法人宝美会　総合青山病院(愛知県)

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 27 Day

Related information
URL releasing protocol	none
Publication of results	Partially published

Result
URL related to results and publications	none
Number of participants that the trial has enrolled	137
Results	referring to a meeting abstract of the 60th Annual Meeting of JSCR
Results date posted	2022 Year 08 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	referring to a meeting abstract of the 60th Annual Meeting of JSCR
Participant flow	referring to a meeting abstract of the 60th Annual Meeting of JSCR
Adverse events	referring to a meeting abstract of the 60th Annual Meeting of JSCR
Outcome measures	referring to a meeting abstract of the 60th Annual Meeting of JSCR
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 01 Month 27 Day
Date of IRB	2020 Year 01 Month 22 Day
Anticipated trial start date	2020 Year 01 Month 27 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Toric intraocular lens used in cataract surgery can acquire good uncorrected visual acuity after surgery by correcting corneal astigmatism. In order to obtain good results in toric IOL implantation, accuracy of preoperative examination, toric model selection, control of induced astigmatism in surgery, and accurate implantation of IOL are important. In particular, toric IOL needs to be fixed to the astigmatic axis, and it it's off axis by 3 degrees, it loses about 3.3% of the refractive correction effect. Therefore, when the axis is shifted by 30 degrees, astigmatic correction effect is completely lost, and only the astigmatic axis may change. Conventionally, using a surgical pen, marking is performed at 0, 3, 6, 9 and 12 o'clock position with a slit lamp microscope before surgery, and fixed position is measured intraoperatively from that position, then toric IOL was implanted. The image guide system is a system that digitizes this technique and refers to anterior segment information photographed in a sitting position before surgery, and displays an accurate toric IOL fixation axis intraoperatively. Shortening of operation time, reduction of human error, and improvement of postoperative axis deviation can be expected. Currently, number of cases of toric IOL implantation are increasing, but until now it has been mostly studied in a single center, and less from multiple centers. The purpose of this study is to investigate prospectively the results after toric IOL implantation as a multi-institutional collaborative study, and to determine whether there is a difference between institutions.

Management information
Registered date	2020 Year 01 Month 27 Day
Last modified on	2022 Year 08 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044780