A Study of Cataract Surgery With the Femtosecond Laser

August 1, 2016 updated by: Abbott Medical Optics

A Study of Cataract Surgery With the Assistance of the Femtosecond Laser

The purpose of this study is to evaluate the feasibility of using the Femtosecond Laser System to perform surgical maneuvers during cataract extraction surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able and willing to comply with the treatment/follow-up schedule and requirements
  • Able to understand and provide written Informed Consent
  • 3. ETDRS visual acuity equal to or worse than 20/30 (best corrected)
  • Patient age between 50 and 80 years old
  • Pupil dilates to at least 8 mm
  • Patient able to fixate
  • 1-3+ nuclear sclerotic cataract(This criterion does not apply to subjects who will receive post-IOL corneal relaxing incisions)
  • Axial length between 22 and 26 mm

Exclusion Criteria:

  • Pregnant, intending to become pregnant during course of study, less than 3 months postpartum or less than 6 weeks after completion of breast feeding
  • 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
  • Anterior chamber depth less than 2.5 mm via Optical Coherence Tomography (Visante, Zeiss) or IOL Master (Zeiss) measurements
  • History of prior ocular surgery
  • History of ocular trauma
  • Co-existing ocular disease affecting vision
  • Astigmatism greater than five diopters (D.)

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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 OptiMedica Catalys™ Precision Laser System (Catalys System)
Procedure: FS Laser Surgery
The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. The intervention consists of the both surgery and the use of the device.
Device: FS Laser System
The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. The intervention consists of the both surgery and the use of the device.
Other Names:
  • OptiMedica Catalys™ Precision Laser System (Catalys System)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Capsulotomy Size
Time Frame: Day of Surgery
Capsulotomy size will be measured during surgery.
Day of Surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulated 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, Santo Domingo, Dominican Republic

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

June 1, 2009

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

June 16, 2009

First Submitted That Met QC Criteria

June 16, 2009

First Posted (Estimate)

June 17, 2009

Study Record Updates

Last Update Posted (Estimate)

August 3, 2016

Last Update Submitted That Met QC Criteria

August 1, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMC-C-1.1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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