UMIN-CTR Clinical Trial

Basic information
Public title	Clinical evaluation of combined minimally invasive glaucoma surgery and cataract surgery using toric intraocular lens
Acronym	MIGS using toric intraocular lens
Scientific Title	Clinical evaluation of combined minimally invasive glaucoma surgery and cataract surgery using toric intraocular lens
Scientific Title:Acronym	MIGS using toric intraocular lens
Region	Japan

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

Objectives
Narrative objectives1	To compare the refractive status between eyes implanted with toric and non-toric intraocular lenses (IOLs) during combined cataract and microhook ab interno trabeculotomy, a minimally invasive glaucoma surgery (MIGS).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcomes were the uncorrected visual acuity (UCVA) and refractive cylinder at 3 months postoperatively.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	toric IOL
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 had open-angle glaucoma, cataract, and pre-existing regular corneal astigmatism exceeding 1.5 diopters, and underwent combined micro LOT and phacoemulsification were recruited retrospectively.
Key exclusion criteria	Eyes were included that had no history of a previous intraocular surgery, no central visual field defect due to glaucoma, no complications during combined micro LOT and cataract surgery, and no postoperative interventions.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name YASUYUKI Middle name Last name TAKAI
Organization	Shimane University Faculty of Medicine
Division name	Department of Ophthalmology
Zip code	6938501
Address	Enya89-1, Izumo, Japan
TEL	0853-20-2284
Email	takai611@med.shimane-u.ac.jp

Public contact
Name of contact person	1st name YASUYUKI Middle name Last name TAKAI
Organization	Shimane University Faculty of Medicine
Division name	Department of Ophthalmology
Zip code	6938501
Address	Enya89-1, Izumo, Japan
TEL	0853-20-2284
Homepage URL
Email	takai611@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University
Institute
Department

Funding Source
Organization	Alcon Japan Ltd. (Tokyo, Japan)
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	IRB of Shimane University Hospital
Address	Enya 89-1, Izumo, Japan
Tel	0853-20-2259
Email	kenkyu@med.shimane-u.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 02 Month 01 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	30
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	No longer recruiting
Date of protocol fixation	2018 Year 09 Month 28 Day
Date of IRB	2018 Year 10 Month 03 Day
Anticipated trial start date	2018 Year 10 Month 05 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 27 Day
Last modified on	2021 Year 01 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049213