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Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts

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: NCT02403206
Recruitment Status : Completed
First Posted : March 31, 2015
Results First Posted : July 25, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( Alcon, a Novartis Company )

Tracking Information
First Submitted Date  ICMJE March 26, 2015
First Posted Date  ICMJE March 31, 2015
Results First Submitted Date  ICMJE May 30, 2017
Results First Posted Date  ICMJE July 25, 2017
Last Update Posted Date July 2, 2018
Actual Study Start Date  ICMJE March 26, 2015
Actual Primary Completion Date July 12, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2017)
Percentage of Capsular Tears (Anterior or Posterior) During Surgery [ Time Frame: Day 0 (operative day) ]
A capsular tear is defined as any unintended tear on the anterior or posterior capsule and includes a radial tear that moves peripherally on the anterior capsule during capsulotomy and extends to form a posterior capsular tear during intumescent cataract surgery. An intumescent cataract is defined as a cataract with a pressurized capsular bag. A lower value indicates fewer capsular tears. Only one eye (study eye) contributed to the analysis.
Original Primary Outcome Measures  ICMJE
 (submitted: March 26, 2015)
Percentage of Capsular Tears (Anterior or Posterior) During Surgery [ Time Frame: Day 0 (operative day) ]
A capsular tear is any unintended tear on the anterior or posterior capsule and includes a radial tear that moves peripherally on the anterior capsule during capsulotomy and extends to form a posterior capsular tear.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2017)
Operating Time in the Eye to Complete Entire Cataract Procedure [ Time Frame: Day 0 (operative day) ]
Operating time in the eye was the time interval (in seconds) from the time the corneal incision was opened to the time the wound was closed. Only one eye (study eye) contributed to the analysis.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2015)
Operating Time in the Eye to Complete Entire Cataract Procedure [ Time Frame: Day 0 (operative day) ]
Operating time in the eye is the time interval from the time the corneal incision is opened to the time the wound is closed.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts
Official Title  ICMJE Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts
Brief Summary The purpose of the study is to compare femtosecond laser-assisted capsulotomy to manual capsulorhexis in patients with intumescent cataracts. An intumescent cataract is defined as a cataract with a pressurized capsular bag.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Intumescent Cataract
Intervention  ICMJE
  • Device: Femtosecond laser
    Laser console and a patient interface used to cut tissue during cataract removal of the crystalline lens
    Other Name: LenSx® Laser
  • Procedure: Continuous Curvilinear Capsulorhexis (CCC)
    Standard-of care manual procedure (using either needles or forceps) for creating capsulorhexis, ie., opening in capsular bag during anterior segment ophthalmic surgery
Study Arms  ICMJE
  • Experimental: Laser
    Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
    Intervention: Device: Femtosecond laser
  • Active Comparator: Manual
    Continuous curvilinear capsulorhexis performed during cataract surgery
    Intervention: Procedure: Continuous Curvilinear Capsulorhexis (CCC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2016)
406
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2015)
425
Actual Study Completion Date  ICMJE August 24, 2016
Actual Primary Completion Date July 12, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Willing to undergo cataract surgery.
  • Able to lie flat in a supine position.
  • Able to understand and willing to sign the Informed Consent Form (ICF).
  • Presenting with intumescent white cataract, with a liquid pressurized bag and a milky, liquid cortex.
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Pregnant or lactating mothers.
  • Corneal disease that precludes application of the cornea or transmission of laser light at 1030 nanometer (nm) wavelength.
  • Corneal opacity that would interfere with the laser beam.
  • Presence of blood or other material in the anterior chamber.
  • Hypotony or presence of corneal implant.
  • Poorly dilating pupils.
  • Condition which would cause inadequate clearance between the intended capsulotomy depth and the endothelium.
  • Residual, recurrent, active ocular or eye lid disease, including any corneal abnormality.
  • Any contraindication to cataract surgery.
  • Other protocol-specified exclusion criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT02403206
Other Study ID Numbers  ICMJE CTW860-P001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research ( Alcon, a Novartis Company )
Study Sponsor  ICMJE Alcon, a Novartis Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Manager, Surgical Alcon, A Novartis Division
PRS Account Alcon Research
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP