A Study of Cataract Surgery With the Femtosecond Laser

Not Applicable

Terminated

• Conditions: Cataract

• 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

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-16
• Study First Submitted QC: 2009-06-16
• Study First Posted: 2009-06-17
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Disposition First Submitted: 2014-05-16
• Disposition First Submitted QC: 2014-07-07
• Disposition First Posted: 2014-07-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04

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
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Capsulotomy Size	Day of Surgery	Capsulotomy size will be measured during surgery.

Secondary Outcome Measures

Name	Time	Method
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.