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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031996
Receipt No. R000036366
Scientific Title Clinical Evaluation of FLACS (Femtosecond Laser Assisted Cataract Surgery) With Combination of LenSx and Centurion
Date of disclosure of the study information 2018/03/30
Last modified on 2019/09/30

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Basic information
Public title Clinical Evaluation of FLACS (Femtosecond Laser Assisted Cataract Surgery)
With Combination of LenSx and Centurion
Acronym Clinical Evaluation of FLACS With Combination of LenSx and Centurion
Scientific Title Clinical Evaluation of FLACS (Femtosecond Laser Assisted Cataract Surgery)
With Combination of LenSx and Centurion
Scientific Title:Acronym Clinical Evaluation of FLACS With Combination of LenSx and Centurion
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to evaluate cumulative dissipated energy (CDE), endothelial cell loss, and average torsional amplitude with combination of LenSx and Centurion compared to conventional cataract surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cumulative Dissipated Energy (CDE)
CDE (the energy dissipated at the incision point during the removal of cataractous lens) will be measured.
[Time Frame: Surgery (Day 0)]
Key secondary outcomes -Percent change of corneal endothelial cell density (ECD)
Specular microscopy will be performed and endothelial cell density will be recorded.
[Time Frame: Day 150-210 post-surgery]

-Average torsional amplitude
Torsional amplitude will be recorded by Centurion and measured as a percentage.
[Time Frame: Surgery (Day 0)]

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 FLACS
-FLACS in 1 eye, with manual conventional surgery in the fellow eye, as randomized.
-Femtosecond Laser Assisted Cataract Surgery, consisting of LenSx and Centurion combination
-CENTURION Vision System
Phacoemulsification aspiration platform for use during cataract surgery
-LenSx
Femtosecond laser system used for continuous curvilinear capsulorhexis (CCC) and lens fragmentation during cataract surgery
Interventions/Control_2 Conventional
-Manual conventional surgery in 1 eye, with FLACS in the fellow eye, as randomized
-Manual conventional surgery
Removal of cataractous lens by phacoemulsification
-CENTURION Vision System
Phacoemulsification aspiration platform for use during cataract surgery
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 -Cataracts (Grade 2-4 of Emery-Little Classification) with planned cataract removal by phacoemulsification in both eyes
-Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures
-Calculated lens power within the available range
-Other protocol-specified inclusion criteria may apply.
Key exclusion criteria -Any pathology that could reduce visual potential
-Hypotony or the presence of a corneal implant
-Residual, recurrent, active ocular or eyelid disease
-Poorly dilating pupil
-Any contraindication to cataract
-Eyes with two different levels of cataract grade
-Pregnant, or planned pregnancy during the study
-Expected to require an ocular surgical treatment at any time during the study
-Other protocol-specified exclusion criteria may apply
Target sample size 55

Research contact person
Name of lead principal investigator
1st name Yoshitaka
Middle name
Last name Oka
Organization OKA EYE CLINIC IIZUKA

Division name Ophthalmology
Zip code 820-0067
Address 371-1 Kawazu, Iizuka-shi, Fukuoka
TEL 0948-22-5155
Email oka@okaganka.com

Public contact
Name of contact person
1st name Yoshinori
Middle name
Last name Shimazaki
Organization Alcon Japan Ltd.
Division name Clinical Development, Clinical & Regulatory Affairs
Zip code 105-6333
Address 1-23-1 Toranomon, Minato-ku, Tokyo
TEL 03-6899-5061
Homepage URL
Email clinicalstudy.japan@alcon.com

Sponsor
Institute Alcon Japan Ltd.
Institute
Department

Funding Source
Organization Alcon Japan Ltd.
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 Clinical Research Network Fukuoka Certified Review Board
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
Tel 092-643-7171
Email mail@crnfukuoka.jp

Secondary IDs
Secondary IDs YES
Study ID_1 NCT03479944
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2 jRCTs072180023
Org. issuing International ID_2 Japan Registry of Clinical Trials
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 30 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 57
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 03 Month 01 Day
Date of IRB
2018 Year 03 Month 29 Day
Anticipated trial start date
2018 Year 08 Month 22 Day
Last follow-up date
2019 Year 05 Month 29 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 06 Month 28 Day
Date analysis concluded
2019 Year 07 Month 02 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 30 Day
Last modified on
2019 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036366

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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