A Study of Cataract Surgery With the Femtosecond Laser
Not Applicable
Terminated
- Conditions
- Cataract
- Interventions
- Procedure: FS Laser SurgeryDevice: 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
-
- 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
Group Intervention Description FS Laser Surgery 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) FS Laser Surgery FS Laser System 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)
- 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.
Trial Locations
- Locations (1)
Laser Center
🇩🇴Santo Domingo, Dominican Republic