Femtosecond Laser for Cataract Surgery

NCT ID: NCT02110212

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-02-28

Brief Summary

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.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

U/S Surgery and CCC

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

Group Type: ACTIVE_COMPARATOR

U/S Surgery and CCC

Intervention Type: PROCEDURE

Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens.

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 femtosecond laser device.

Group Type: EXPERIMENTAL

FS Laser Surgery

Intervention Type: DEVICE

The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery.

Interventions

U/S Surgery and CCC

Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens.

Intervention Type: PROCEDURE

FS Laser Surgery

The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery.

Intervention Type: DEVICE

Other Intervention Names

Standard of care for U/S and CCC was required.; OptiMedica Catalys™ Precision Laser System (Catalys System)

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Optics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan F. Batlle, MD

Role: PRINCIPAL_INVESTIGATOR

Laser Center

William W. Culbertson, MD

Role: STUDY_DIRECTOR

Bascom Palmer Eye Institute

Other Identifiers

OMC-C-3.0

Identifier Type: -

Identifier Source: org_study_id