Femtosecond Laser for Cataract Surgery

January 31, 2025 updated by: Abbott Medical Optics

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: U/S Surgery and CCC
Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC).
Procedure: U/S Surgery and CCC
Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens.
Other Names:
  • Standard of care for U/S and CCC was required.
Experimental: FS Laser Surgery
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.
Device: FS Laser Surgery
The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery.
Other Names:
  • OptiMedica Catalys™ Precision Laser System (Catalys System)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Capsulotomy Dimension
Time Frame: Day of Surgery
Capsulotomy size will be measured during surgery for both the experimental and control groups.
Day of Surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Dissipated Energy (CDE)
Time Frame: Day of Surgery
CDE (the amount of ultrasound energy delivered during phacoemulsification of the crystalline lens) used will be measured during surgery.
Day of Surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Optics

Investigators

  • Principal Investigator: Juan F. Batlle, MD, Laser Center
  • Study Director: William W. Culbertson, MD, Bascom Palmer Eye Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

April 8, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimated)

April 10, 2014

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMC-C-3.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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