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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033661
Receipt No. R000038376
Official scientific title of the study Efficacy study of cataract surgery using femtosecond laser
Date of disclosure of the study information 2018/08/07
Last modified on 2018/08/07

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Basic information
Official scientific title of the study Efficacy study of cataract surgery using femtosecond laser
Title of the study (Brief title) 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 Kazuo Ichikawa
Organization Chukyo Eye Clinic
Division name Ophthalmology
Address 12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya, Aichi
TEL 052-883-1543
Email ichikawa@chukyogroup.jp

Public contact
Name of contact person Mari Mitamura
Organization Chukyo Eye Clinic
Division name Ophthalmology
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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 08 Month 07 Day
Anticipated trial start date
2018 Year 08 Month 07 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 08 Month 07 Day
Last modified on
2018 Year 08 Month 07 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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