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Study of the Femtosecond Laser System as Compared to Continuous Curvilinear Capsulorhexis for Cataract Surgery

Primary Purpose

Cataract

Status
Completed
Phase
Phase 3
Locations
Dominican Republic
Study Type
Interventional
Intervention
FS Laser Surgery
CCC 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 (Early Treatment of Diabetic Retinopathy Study) visual acuity equal to or worse than 20/32 (best corrected)
  • Age between 50 and 80 years old
  • Pupil dilates to at least 7 mm
  • Subject able to fixate
  • Grade 1-4 nuclear sclerotic cataract (Lens Opacities Classification System - 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

Experimental

Active Comparator

Arm Label

FS Laser Surgery

CCC Surgery

Arm Description

For femtosecond laser-assisted cataract surgery group (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device. If necessary, ultrasound (U/S) phacoemulsification will also be applied to facilitate removal of the crystalline lens during cataract surgery.

For the continuous curvilinear capsulorhexis (CCC) group (CCC Surgery), subjects will receive the standard of care for CCC and U/S phacoemulsification surgery to facilitate removal of the crystalline lens during cataract surgery.

Outcomes

Primary Outcome Measures

Deviation From Intended Capsulotomy Diameter
Capsulotomy diameter 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. CDE is a unit used for the Alcon Infinity System (the U/S phacoemulsification used in this study). It is not expressed in standard units such as watts or Joules. CDE, which accounts for the power and time of two ultrasound delivery modes (longitudinal and torsional), is calculated as follows: CDE = (Phaco time x average phaco power) + (torsional time x average torsional aptitude x 0.4) 0.4 is a factor representing the approximate reduction of heat dissipated at the incision as compared to conventional phacoemulsification.

Full Information

First Posted
February 13, 2010
Last Updated
August 25, 2014
Sponsor
Abbott Medical Optics
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1. Study Identification

Unique Protocol Identification Number
NCT01069172
Brief Title
Study of the Femtosecond Laser System as Compared to Continuous Curvilinear Capsulorhexis 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
August 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
August 2010 (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 purpose of this study is to evaluate the safety and efficacy of the OptiMedica Femtosecond Laser System to perform surgical maneuvers used in the treatment of subjects with cataracts. The safety and efficacy will be compared 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
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FS Laser Surgery
Arm Type
Experimental
Arm Description
For femtosecond laser-assisted cataract surgery group (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device. If necessary, ultrasound (U/S) phacoemulsification will also be applied to facilitate removal of the crystalline lens during cataract surgery.
Arm Title
CCC Surgery
Arm Type
Active Comparator
Arm Description
For the continuous curvilinear capsulorhexis (CCC) group (CCC Surgery), subjects will receive the standard of care for CCC and U/S phacoemulsification surgery to facilitate removal of the crystalline lens during cataract surgery.
Intervention Type
Device
Intervention Name(s)
FS Laser Surgery
Other Intervention Name(s)
OptiMedica Catalys™ Precision Laser System (Catalys System) = femtosecond laser; Alcon Infiniti System = U/S (ultrasound) phacoemulsification system
Intervention Description
The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery to perform capsulotomy, lens segmentation, and lens softening, which are all part of cataract surgery when this femtosecond laser is used.
Intervention Type
Procedure
Intervention Name(s)
CCC Surgery
Other Intervention Name(s)
Alcon Infiniti System = U/S (ultrasound) phacoemulsification system.
Intervention Description
Subjects will receive the standard of care for CCC and U/S cataract surgery to facilitate removal of the crystalline lens. CCC is a procedure that is part of cataract surgery.
Primary Outcome Measure Information:
Title
Deviation From Intended Capsulotomy Diameter
Description
Capsulotomy diameter 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. CDE is a unit used for the Alcon Infinity System (the U/S phacoemulsification used in this study). It is not expressed in standard units such as watts or Joules. CDE, which accounts for the power and time of two ultrasound delivery modes (longitudinal and torsional), is calculated as follows: CDE = (Phaco time x average phaco power) + (torsional time x average torsional aptitude x 0.4) 0.4 is a factor representing the approximate reduction of heat dissipated at the incision as compared to conventional phacoemulsification.
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 (Early Treatment of Diabetic Retinopathy Study) visual acuity equal to or worse than 20/32 (best corrected) Age between 50 and 80 years old Pupil dilates to at least 7 mm Subject able to fixate Grade 1-4 nuclear sclerotic cataract (Lens Opacities Classification System - 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 Culberston, 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

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Study of the Femtosecond Laser System as Compared to Continuous Curvilinear Capsulorhexis for Cataract Surgery

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