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Trial record 2 of 114 for:    centurion

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03479944
Recruitment Status : Completed
First Posted : March 27, 2018
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

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.

Condition or disease Intervention/treatment Phase
Cataract Procedure: FLACS Procedure: Manual conventional surgery Device: CENTURION® Vision System Device: LenSx® Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of FLACS (Femtosecond Laser Assisted Cataract Surgery) With Combination of LenSx® and Centurion®
Actual Study Start Date : August 22, 2018
Actual Primary Completion Date : November 19, 2018
Actual Study Completion Date : May 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: FLACS
FLACS in 1 eye, with manual conventional surgery in the fellow eye, as randomized
Procedure: FLACS
Femtosecond laser assisted cataract surgery consisting of LenSx® and Centurion® combination

Device: CENTURION® Vision System
Phacoemulsification aspiration platform for use during cataract surgery

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

Active Comparator: Conventional
Manual conventional surgery in 1 eye, with FLACS in the fellow eye, as randomized
Procedure: Manual conventional surgery
Removal of cataractous lens by phacoemulsification

Device: CENTURION® Vision System
Phacoemulsification aspiration platform for use during cataract surgery




Primary Outcome Measures :
  1. Cumulative Dissipated Energy (CDE) [ Time Frame: Surgery (Day 0) ]
    CDE (the energy dissipated at the incision point during the removal of cataractous lens) will be measured.


Secondary Outcome Measures :
  1. Percent change of corneal endothelial cell density (ECD) [ Time Frame: Day 150-210 post-surgery ]
    Specular microscopy will be performed and endothelial cell density will be recorded.

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



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479944


Locations
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Japan
Alcon Investigative Site
Iizuka City, Fukuoka, Japan, 820-0067
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Alcon, A Novartis Division Alcon, A Novartis Division

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03479944     History of Changes
Other Study ID Numbers: CTB258-P001
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases