Status:
TERMINATED
A Study of Cataract Surgery With the Femtosecond Laser
Lead Sponsor:
Abbott Medical Optics
Conditions:
Cataract
Eligibility:
All Genders
50-80 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00922571
Start Date
June 1 2009
End Date
May 1 2014
Last Update
February 4 2025
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