NCT03479944

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

August 22, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2019

Completed
7 months until next milestone

Results Posted

Study results publicly available

December 16, 2019

Completed
Last Updated

December 16, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

March 21, 2018

Results QC Date

November 6, 2019

Last Update Submit

November 27, 2019

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Preoperative, Day 150-210 (post-operative)

  • Percentage of Average Torsional Amplitude

    Day 0 (operative day)

Study Arms (2)

FLACS

EXPERIMENTAL

Femtosecond laser assisted cataract surgery (FLACS) in 1 eye, with manual conventional surgery in the fellow eye, as randomized

Procedure: FLACSDevice: CENTURION® Vision SystemDevice: LenSx®

Conventional

ACTIVE COMPARATOR

Manual conventional surgery in 1 eye, with FLACS in the fellow eye, as randomized

Procedure: Manual conventional surgeryDevice: CENTURION® Vision System

Interventions

FLACSPROCEDURE

Femtosecond laser assisted cataract surgery consisting of LenSx® and Centurion® combination

FLACS
Manual conventional surgeryPROCEDURE

Removal of cataractous lens by phacoemulsification

Conventional
CENTURION® Vision SystemDEVICE

Phacoemulsification aspiration platform for use during cataract surgery

ConventionalFLACS
LenSx®DEVICE

Femtosecond laser system used for continuous curvilinear capsulorhexis (CCC) and lens fragmentation during cataract surgery

FLACS

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcon Investigative Site

Iizuka, Fukuoka, 820-0067, Japan

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Results Point of Contact

Title
Group Manager, Surgical, Alcon Japan
Organization
Alcon Japan Ltd.
alcon.medinfo@alcon.com
03-6899-5061

Study Officials

  • Alcon, A Novartis Division

    Alcon, A Novartis Division

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2018

First Posted

March 27, 2018

Study Start

August 22, 2018

Primary Completion

November 19, 2018

Study Completion

May 17, 2019

Last Updated

December 16, 2019

Results First Posted

December 16, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)