CataractNCT03479944

Clinical Evaluation of FLACS With Combination of LenSx® and Centurion®

A study testing FLACS, Manual conventional surgery and CENTURION® Vision System in people with Cataract, run by Alcon Research at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Cataract
What is being tested?: FLACS, Manual conventional surgery and CENTURION® Vision System
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 1 siteJapan
Study dates: 22 Aug 2018to 17 May 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 9Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Alcon Investigative Site
Iizuka, Fukuoka, 820-0067

Other trials in Japan

About this study

Official title: Clinical Evaluation of FLACS (Femtosecond Laser Assisted Cataract Surgery) With Combination of LenSx® and Centurion®

Read the detailed description

Subjects will attend 7 scheduled visits: 1 pre-operative, 1 operative, and 5 post-operative.

Conditions: Cataract
Being tested: FLACS, Manual conventional surgery, CENTURION® Vision System, LenSx®
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FLACSProcedure or surgery
Femtosecond laser assisted cataract surgery consisting of LenSx® and Centurion® combination
Manual conventional surgeryProcedure or surgery
Removal of cataractous lens by phacoemulsification
CENTURION® Vision SystemDevice
Phacoemulsification aspiration platform for use during cataract surgery
LenSx®Device
Femtosecond laser system used for continuous curvilinear capsulorhexis (CCC) and lens fragmentation during cataract surgery

Study groups in NCT03479944
Study group	Role	What they receive
FLACS	Experimental	Femtosecond laser assisted cataract surgery (FLACS) in 1 eye, with manual conventional surgery in the fellow eye, as randomized Receives: Procedure: FLACS; Device: CENTURION® Vision System; Device: LenSx®
Conventional	Active comparator	Manual conventional surgery in 1 eye, with FLACS in the fellow eye, as randomized Receives: Procedure: Manual conventional surgery; Device: CENTURION® Vision System

What is being measured

The primary outcome is the main question the study is designed to answer.

Cumulative Dissipated Energy (CDE)
CDE is not expressed in standard units such as Watts or Joules and accounts for the power and time of longitudinal and torsional ultrasound delivery modes. CDE (the sum total of phacoemulsification energy dissipated at the incision point during the removal of cataractous lens with Centurion® Vision System footpedal in Position 3) was calculated by the Centurion® Vision System as follows: CDE = (Longitudinal time) x (Average longitudinal power) + (Torsional time x 0.4 x Average torsional amplitude). A lower CDE value indicates that less energy was expended in the eye.
Measured: Day 0 (operative day)

Secondary outcomes (2)

Percent Change of Corneal Endothelial Cell Density (ECD) at Visit 5 (150-210 Days After Surgery) From Pre-Operative Visit
Central endothelial cell counts were assessed using specular microscopy. ECD was measured in cells per square millimeter (mm2). The endothelium maintains corneal hydration, and positive percent change value indicates an improvement. In turn, a less negative percent change value is preferable over a more negative percent change value.
Measured: Preoperative, Day 150-210 (post-operative)
Percentage of Average Torsional Amplitude
Torsional amplitude (the amplitude of the oscillations of the phacoemulsification tip) was reported on the Centurion® Vision System interface as a percentage from 0 to 100, where 100 represents maximum amplitude. A lower percentage value indicates greater efficiency in the phacoemulsification process.
Measured: Day 0 (operative day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Aug 201817 May 2019

First posted27 Mar 2018
Study start22 Aug 2018
Primary completion19 Nov 2018
Study completion17 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CataractStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03479944
Sponsor's protocol ID: CTB258-P001
Status last verified: Nov 2019
First submitted: 21 Mar 2018
Last updated: 16 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of FLACS (Femtosecond Laser Assisted Cataract Surgery) With Combination of LenSx® and Centurion®
ClinicalTrials.gov ID: NCT03479944
Acronym / sponsor ID: CTB258-P001
Conditions: Cataract
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 22 Aug 2018 (actual)
Primary completion: 19 Nov 2018 (actual)
Study completion: 17 May 2019 (actual)
First posted: 27 Mar 2018 (actual)
Results: Posted 16 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Subjects will attend 7 scheduled visits: 1 pre-operative, 1 operative, and 5 post-operative.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
FLACS	Experimental	Procedure: FLACS, Device: CENTURION® Vision System, Device: LenSx®Femtosecond laser assisted cataract surgery (FLACS) in 1 eye, with manual conventional surgery in the fellow eye, as randomized
Conventional	Active comparator	Procedure: Manual conventional surgery, Device: CENTURION® Vision SystemManual conventional surgery in 1 eye, with FLACS in the fellow eye, as randomized

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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 (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FLACSFemtosecond laser assisted cataract surgery consisting of LenSx® and Centurion® combination	Procedure or surgery	FLACS
Manual conventional surgeryRemoval of cataractous lens by phacoemulsification	Procedure or surgery	Conventional
CENTURION® Vision SystemPhacoemulsification aspiration platform for use during cataract surgery	Device	Conventional, FLACS
LenSx®Femtosecond laser system used for continuous curvilinear capsulorhexis (CCC) and lens fragmentation during cataract surgery	Device	FLACS

Primary outcome

Cumulative Dissipated Energy (CDE)
Time frame: Day 0 (operative day)
CDE is not expressed in standard units such as Watts or Joules and accounts for the power and time of longitudinal and torsional ultrasound delivery modes. CDE (the sum total of phacoemulsification energy dissipated at the incision point during the removal of cataractous lens with Centurion® Vision System footpedal in Position 3) was calculated by the Centurion® Vision System as follows: CDE = (Longitudinal time) x (Average longitudinal power) + (Torsional time x 0.4 x Average torsional amplitude). A lower CDE value indicates that less energy was expended in the eye.

2 secondary outcomes

Percent Change of Corneal Endothelial Cell Density (ECD) at Visit 5 (150-210 Days After Surgery) From Pre-Operative Visit
Time frame: Preoperative, Day 150-210 (post-operative)
Percentage of Average Torsional Amplitude
Time frame: Day 0 (operative day)

Results and safety

Results posted to the registry on 16 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Subjects	55	55

Primary outcome: Cumulative Dissipated Energy (CDE)

Time frame: Day 0 (operative day). Mean (Standard Deviation). Unit: unitless

Measure	FLACS n = 53	Conventional n = 53
Value	0.213 (0.334)	1.718 (0.898)

FLACS vs Conventional: Least Squares Mean Difference: -1.505 (95% CI -1.720 to -1.289), p <0.0001, t-test based on MMRM

Population analysed: All eyes with successful cataract surgery for which anterior capsulotomy and lens fragmentation have been completed using the assigned surgical techniques (Full Analysis Set).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of initial treatment through study conclusion, for an average individual duration of 150 to 120 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ocular Adverse Events - FLACS	0 of 55 (0%)	0 of 55 (0%)	0 of 55
Ocular Adverse Events - Conventional	0 of 55 (0%)	0 of 55 (0%)	0 of 55
Non-Ocular Adverse Events	2 of 55 (3.6%)	0 of 55 (0%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alcon, A Novartis Division study director

Alcon, A Novartis Division

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FLACS, Manual conventional surgery and CENTURION® Vision System in people with Cataract, run by Alcon Research at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Dissipated Energy (CDE) (time frame: Day 0 (operative day)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03479944.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.