search
Back to results

Femtosecond Laser for Cataract Surgery

Primary Purpose

Cataract

Status
Terminated
Phase
Phase 3
Locations
Dominican Republic
Study Type
Interventional
Intervention
U/S Surgery and CCC
FS Laser Surgery
Sponsored by
Abbott Medical Optics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Cataract, Surgery, cataract extraction, Optical devices, laser

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Able and willing to comply with the treatment/follow-up schedule and requirements
  • Able to understand and provide written Informed Consent
  • ETDRS visual acuity equal to or worse than 20/32 (best corrected)
  • Age between 50 and 80 years old
  • Pupil dilates to at least 6 mm
  • Subject able to fixate
  • Grade 1-4 nuclear sclerotic cataract (LOCS III)
  • Axial length between 22 and 26 mm

Exclusion Criteria:

  • Pregnant, intending to become pregnant during course of the study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
  • Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria
  • Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study or for which cataract surgery is contraindicated
  • Anterior chamber depth (anterior corneal surface to anterior capsule margin) less than 2.5 mm via IOL Master (Zeiss).
  • History of prior ocular surgery
  • History of ocular trauma
  • Co-existing ocular disease affecting vision
  • History or current use of alpha-1 antagonist medication (e.g., Flomax)
  • Known sensitivity to planned concomitant medications

Sites / Locations

  • Laser Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

U/S Surgery and CCC

FS Laser Surgery

Arm Description

Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC).

For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.

Outcomes

Primary Outcome Measures

Capsulotomy Dimension
Capsulotomy size will be measured during surgery for both the experimental and control groups.

Secondary Outcome Measures

Cumulative Dissipated Energy (CDE)
CDE (the amount of ultrasound energy delivered during phacoemulsification of the crystalline lens) used will be measured during surgery.

Full Information

First Posted
April 8, 2014
Last Updated
June 27, 2014
Sponsor
Abbott Medical Optics
search

1. Study Identification

Unique Protocol Identification Number
NCT02110212
Brief Title
Femtosecond Laser for Cataract Surgery
Official Title
A Prospective, Randomized Study of Cataract Surgery With the Assistance of the OptiMedica Femtosecond Laser System Compared to Standard Surgical Procedure of Continuous Curvilinear Capsulorhexis and Ultrasonic Phacoemulsification
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
FDA approval received for product, no additional study subjects required.
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Optics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to evaluate the safety and efficacy the OptiMedica Femtosecond Laser System, also known as the Catalys™ Precision Laser System, to perform two surgical maneuvers used in the treatment of subjects with cataracts. Efficacy will be evaluated by comparisons to the standard surgical procedure of continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, Surgery, cataract extraction, Optical devices, laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
U/S Surgery and CCC
Arm Type
Active Comparator
Arm Description
Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC).
Arm Title
FS Laser Surgery
Arm Type
Experimental
Arm Description
For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.
Intervention Type
Procedure
Intervention Name(s)
U/S Surgery and CCC
Other Intervention Name(s)
Standard of care for U/S and CCC was required.
Intervention Description
Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens.
Intervention Type
Device
Intervention Name(s)
FS Laser Surgery
Other Intervention Name(s)
OptiMedica Catalys™ Precision Laser System (Catalys System)
Intervention Description
The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery.
Primary Outcome Measure Information:
Title
Capsulotomy Dimension
Description
Capsulotomy size will be measured during surgery for both the experimental and control groups.
Time Frame
Day of Surgery
Secondary Outcome Measure Information:
Title
Cumulative Dissipated Energy (CDE)
Description
CDE (the amount of ultrasound energy delivered during phacoemulsification of the crystalline lens) used will be measured during surgery.
Time Frame
Day of Surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able and willing to comply with the treatment/follow-up schedule and requirements Able to understand and provide written Informed Consent ETDRS visual acuity equal to or worse than 20/32 (best corrected) Age between 50 and 80 years old Pupil dilates to at least 6 mm Subject able to fixate Grade 1-4 nuclear sclerotic cataract (LOCS III) Axial length between 22 and 26 mm Exclusion Criteria: Pregnant, intending to become pregnant during course of the study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study or for which cataract surgery is contraindicated Anterior chamber depth (anterior corneal surface to anterior capsule margin) less than 2.5 mm via IOL Master (Zeiss). History of prior ocular surgery History of ocular trauma Co-existing ocular disease affecting vision History or current use of alpha-1 antagonist medication (e.g., Flomax) Known sensitivity to planned concomitant medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan F. Batlle, MD
Organizational Affiliation
Laser Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William W. Culbertson, MD
Organizational Affiliation
Bascom Palmer Eye Institute
Official's Role
Study Director
Facility Information:
Facility Name
Laser Center
City
Santo Domingo
Country
Dominican Republic

12. IPD Sharing Statement

Learn more about this trial

Femtosecond Laser for Cataract Surgery

We'll reach out to this number within 24 hrs