A Study of Cataract Surgery With the Femtosecond Laser

NCT ID: NCT00922571

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2014-05-31

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.

Conditions

Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

FS Laser Surgery

Intervention Type: PROCEDURE

The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. The intervention consists of the both surgery and the use of the device.

FS Laser System

Intervention Type: DEVICE

The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. The intervention consists of the both surgery and the use of the device.

Interventions

FS Laser Surgery

The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. The intervention consists of the both surgery and the use of the device.

Intervention Type: PROCEDURE

FS Laser System

The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. The intervention consists of the both surgery and the use of the device.

Intervention Type: DEVICE

Other Intervention Names

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
• 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.)

• 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, Santo Domingo, Dominican Republic

Other Identifiers

OMC-C-1.1

Identifier Type: -

Identifier Source: org_study_id