Femtosecond Laser for Cataract Surgery

Abbott

Status and phase: Terminated; Phase 3

Conditions: Cataract

Treatments: Procedure: U/S Surgery and CCC; Device: FS Laser Surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT02110212

OMC-C-3.0

Details and patient eligibility

About

The objective of this study is to evaluate the safety and efficacy the OptiMedica Femtosecond Laser System, also known as the Catalys™ Precision Laser System, to perform two surgical maneuvers used in the treatment of subjects with cataracts. Efficacy will be evaluated by comparisons to the standard surgical procedure of continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.

Enrollment: 17 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
• ETDRS visual acuity equal to or worse than 20/32 (best corrected)
• Age between 50 and 80 years old
• Pupil dilates to at least 6 mm
• Subject able to fixate
• Grade 1-4 nuclear sclerotic cataract (LOCS III)
• Axial length between 22 and 26 mm

Exclusion criteria

• Pregnant, intending to become pregnant during course of the study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
• 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 or for which cataract surgery is contraindicated
• Anterior chamber depth (anterior corneal surface to anterior capsule margin) less than 2.5 mm via IOL Master (Zeiss).
• History of prior ocular surgery
• History of ocular trauma
• Co-existing ocular disease affecting vision
• History or current use of alpha-1 antagonist medication (e.g., Flomax)
• Known sensitivity to planned concomitant medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

U/S Surgery and CCC

Active Comparator group

Description:

Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC).

Treatment:

Procedure: U/S Surgery and CCC

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 femtosecond laser device.

Treatment:

Device: FS Laser Surgery