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

Abbott Medical Optics0 sites100 target enrollmentJune 2009

ConditionsCataract

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cataract
Sponsor: Abbott Medical Optics
Enrollment: 100
Primary Endpoint: Capsulotomy Size
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

May 2014

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Abbott Medical Optics

Responsible Party

Sponsor

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 20/30 (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.)