UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031996 |
|---|---|
| Receipt number | 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 17:26:52 |
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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
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
clinicalstudy.japan@alcon.com
Sponsor or person
Institute
Alcon Japan Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036366
