UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy study of cataract surgery using femtosecond laser
Acronym	Study of FLACS efficacy
Scientific Title	Efficacy study of cataract surgery using femtosecond laser
Scientific Title:Acronym	Study of FLACS efficacy
Region	Japan

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

Objectives
Narrative objectives1	To compare postoperative progress of FLACS by multiple surgeons
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Complications, visual acuity and intraocular pressue one day, 5 days, 1 month, 3 months, 6 months after the surgery, corneal endothelial cell density, flare value, corneal shape will be studied and slit lamp microscopy will be conducted.
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Femtosecond laser cataract surgery device will be used during cataract surgery (operator A)
Interventions/Control_2	Femtosecond laser cataract surgery device will be used during cataract surgery (operator B)
Interventions/Control_3	Femtosecond laser cataract surgery device will be used during cataract surgery (operator C)
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient with visual function disorder due to cataract Emery-Little classification of grade I to IV cataract
Key exclusion criteria	Patient with Grade V cataract of Emery-Little classification, mature cataract, hypermature cataract, corneal disease, corneal opacity, macular disease or advanced glaucoma patient who is likely to have lower visual acuity after the surgery, uncontrolled diabetes, patient who cannot fix vision intraoperatively, who cannot rest, open eyelid, dilate pupil (exfoliation syndrome, etc.) , and patient with history of trauma.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name Ichikawa
Organization	Chukyo Eye Clinic
Division name	Ophthalmology
Zip code	4560032
Address	12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya, Aichi
TEL	052-883-1543
Email	ichikawa@chukyogroup.jp

Public contact
Name of contact person	1st name Mari Middle name Last name Mitamura
Organization	Chukyo Eye Clinic
Division name	Ophthalmology
Zip code	4560032
Address	12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya, Aichi
TEL	052-883-1543
Homepage URL
Email	takagi@chukyogroup.jp

Sponsor
Institute	Chukyo Eye Clinic
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	IRB of Chukyo Medical Co.,Ltd
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	2018 Year 08 Month 07 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	100
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	2018 Year 08 Month 07 Day
Date of IRB	2018 Year 08 Month 07 Day
Anticipated trial start date	2018 Year 08 Month 07 Day
Last follow-up date	2023 Year 08 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 08 Month 07 Day
Last modified on	2021 Year 02 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038376