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

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 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

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

Value
https://center6.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