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Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts

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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 )

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.

Condition or disease Intervention/treatment Phase
Intumescent Cataract Device: Femtosecond laser Procedure: Continuous Curvilinear Capsulorhexis (CCC) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 406 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts
Actual Study Start Date : March 26, 2015
Actual Primary Completion Date : July 12, 2016
Actual Study Completion Date : August 24, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: Laser
Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
Device: Femtosecond laser
Laser console and a patient interface used to cut tissue during cataract removal of the crystalline lens
Other Name: LenSx® Laser

Active Comparator: Manual
Continuous curvilinear capsulorhexis performed during cataract surgery
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02403206


Sponsors and Collaborators
Alcon, a Novartis Company
Investigators
Study Director: Clinical Manager, Surgical Alcon, A Novartis Division

Additional Information:
Responsible Party: Alcon, a Novartis Company
ClinicalTrials.gov Identifier: NCT02403206     History of Changes
Other Study ID Numbers: CTW860-P001
First Posted: March 31, 2015    Key Record Dates
Results First Posted: July 25, 2017
Last Update Posted: July 2, 2018
Last Verified: June 2017

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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases