Back to resultsFemtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts
Primary Purpose
Intumescent Cataract
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Femtosecond laser
Continuous Curvilinear Capsulorhexis (CCC)
Sponsored by
About this trial
This is an interventional treatment trial for Intumescent Cataract
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laser
Manual
Arm Description
Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
Continuous curvilinear capsulorhexis performed during cataract surgery
Outcomes
Primary Outcome Measures
Percentage of Capsular Tears (Anterior or Posterior) During Surgery
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
Operating Time in the Eye to Complete Entire Cataract Procedure
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02403206
Brief Title
Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts
Official Title
Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 26, 2015 (Actual)
Primary Completion Date
July 12, 2016 (Actual)
Study Completion Date
August 24, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon, a Novartis Company
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intumescent Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
406 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser
Arm Type
Experimental
Arm Description
Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
Arm Title
Manual
Arm Type
Active Comparator
Arm Description
Continuous curvilinear capsulorhexis performed during cataract surgery
Intervention Type
Device
Intervention Name(s)
Femtosecond laser
Other Intervention Name(s)
LenSx® Laser
Intervention Description
Laser console and a patient interface used to cut tissue during cataract removal of the crystalline lens
Intervention Type
Procedure
Intervention Name(s)
Continuous Curvilinear Capsulorhexis (CCC)
Intervention Description
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 Measure Information:
Title
Percentage of Capsular Tears (Anterior or Posterior) During Surgery
Description
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.
Time Frame
Day 0 (operative day)
Secondary Outcome Measure Information:
Title
Operating Time in the Eye to Complete Entire Cataract Procedure
Description
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.
Time Frame
Day 0 (operative day)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Manager, Surgical
Organizational Affiliation
Alcon, A Novartis Division
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts
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