A Study of Cataract Surgery With the Femtosecond Laser

NCT00922571 | Terminated

• 1 other identifier: OMC-C-1.1
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Keywords

Cataract; Femtosecond laser

Outcome Measures

Primary Outcomes (1)

• Capsulotomy Size

  Capsulotomy size will be measured during surgery.

  Day of Surgery

Secondary Outcomes (1)

• Cumulated Dissipated Energy (CDE)

  Day of surgery

Study Arms (1)

FS Laser Surgery

EXPERIMENTAL

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)

Procedure: FS Laser Surgery; Device: FS Laser System

Interventions

FS Laser Surgery 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 Surgery

FS Laser System 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.

Also known as: OptiMedica Catalys™ Precision Laser System (Catalys System)

FS Laser Surgery

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 20/30 (best corrected)
• Patient age between 50 and 80 years old
• Pupil dilates to at least 8 mm
• Patient able to fixate
• + 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Abbott Medical Optics: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Juan F. Batlle, MD

  Laser Center, Santo Domingo, Dominican Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 17, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 4, 2025

Record last verified: 2025-01