UMIN-CTR Clinical Trial

Basic information
Public title	Simple surgical technique for accurate implantation of toric intraocular lenses
Acronym	Simple technique for implantation of toric intraocular lens
Scientific Title	Simple surgical technique for accurate implantation of toric intraocular lenses
Scientific Title:Acronym	Simple technique for implantation of toric intraocular lens
Region	Japan

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

Objectives
Narrative objectives1	To compare the degree of toric IOL rotation during OVD removal using conventional surgical technique and the degree of toric IOL rotation using current technique.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Images taken before and after removal of OVD are captured from the recorded video. A reference line is determined by connecting two critical details, and another line is determined by joining two details on the IOL. The angle at intersection of these two lines is measured, and the difference in the angles before and after OVD removal was defined as the angle of rotation. The angle of rotation during OVD removal using the current technique and conventional technique are compared. The angle of rotation using conventional technique is published in previous study.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent cataract surgery with implantation of toric IOL using the current technique.
Key exclusion criteria	Patients deemed inappropriate by the principal investigator or sub-investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Tsutomu Middle name Last name Ohashi
Organization	Medical Corporation Ohashi Eye Center
Division name	President
Zip code	003-0027
Address	Kita 1-1 Hondori 6, Shiroishi, Sapporo, 003-0027 Japan
TEL	011-864-4656
Email	ohashi@rainbow.ne.jp

Public contact
Name of contact person	1st name Tsutomu Middle name Last name Ohashi
Organization	Medical Corporation Ohashi Eye Center
Division name	President
Zip code	003-0027
Address	Kita 1-1 Hondori 6, Shiroishi, Sapporo, 003-0027 Japan
TEL	011-864-4656
Homepage URL
Email	ohashi@rainbow.ne.jp

Sponsor
Institute	Medical Corporation Ohashi Eye Center
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 Eye Clinic, REC
Address	12-23 Sanbonmatsu-cho Atsuta-ku, Nagoya city 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

Other administrative information
Date of disclosure of the study information	2022 Year 02 Month 24 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	20
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	Completed
Date of protocol fixation	2021 Year 10 Month 06 Day
Date of IRB	2021 Year 10 Month 06 Day
Anticipated trial start date	2021 Year 11 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The conventional surgical technique using OVD, IOL is inserted into capsular bag filled with OVD, adjust the position of the IOL, and then remove the OVD. In this method, the IOL rotates during removal of the OVD and needs to be readjusted. With the new technique, after inserting of toric IOL, OVD is injected above the IOL and BSS is injected under the OVD. IOL is rotated to the final position and the OVD is removed.

Management information
Registered date	2022 Year 02 Month 24 Day
Last modified on	2022 Year 02 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053610