A Study of Cataract Surgery With the Femtosecond Laser

Abbott

Status: Terminated

Conditions: Cataract

Treatments: Procedure: FS Laser Surgery; Device: FS Laser System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00922571

OMC-C-1.1

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

FS Laser Surgery

Experimental group

Description:

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)

Treatment:

Device: FS Laser System

Procedure: FS Laser Surgery