Study of the Femtosecond Laser System as Compared to Continuous Curvilinear Capsulorhexis for Cataract Surgery

Abbott

Status and phase: Completed; Phase 3

Conditions: Cataract

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01069172

OMC-C-2.0

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of the OptiMedica Femtosecond Laser System to perform surgical maneuvers used in the treatment of subjects with cataracts. The safety and efficacy will be compared to the standard surgical procedure of continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.

Enrollment: 30 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 (Early Treatment of Diabetic Retinopathy Study) visual acuity equal to or worse than 20/32 (best corrected)
• Age between 50 and 80 years old
• Pupil dilates to at least 7 mm
• Subject able to fixate
• Grade 1-4 nuclear sclerotic cataract (Lens Opacities Classification System - 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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30 participants in 2 patient groups

FS Laser Surgery

Experimental group

Description:

For femtosecond laser-assisted cataract surgery group (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device. If necessary, ultrasound (U/S) phacoemulsification will also be applied to facilitate removal of the crystalline lens during cataract surgery.

Treatment:

Device: FS Laser Surgery

CCC Surgery

Active Comparator group

Description:

For the continuous curvilinear capsulorhexis (CCC) group (CCC Surgery), subjects will receive the standard of care for CCC and U/S phacoemulsification surgery to facilitate removal of the crystalline lens during cataract surgery.

Treatment:

Procedure: CCC Surgery