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A Study of Cataract Surgery With the Femtosecond Laser

Not Applicable
Terminated
Conditions
Cataract
Interventions
Procedure: FS Laser Surgery
Device: FS Laser System
Registration Number
NCT00922571
Lead Sponsor
Abbott Medical Optics
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
100
Inclusion Criteria
  • Able and willing to comply with the treatment/follow-up schedule and requirements
  • Able to understand and provide written Informed Consent
    1. 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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
FS Laser SurgeryFS Laser SurgeryFor 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)
FS Laser SurgeryFS Laser SystemFor 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)
Primary Outcome Measures
NameTimeMethod
Capsulotomy SizeDay of Surgery

Capsulotomy size will be measured during surgery.

Secondary Outcome Measures
NameTimeMethod
Cumulated Dissipated Energy (CDE)Day of surgery

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

Trial Locations

Locations (1)

Laser Center

🇩🇴

Santo Domingo, Dominican Republic

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