Femtosecond Laser for Cataract Surgery

NCT02110212 | Terminated Phase 3

• 1 other identifier: OMC-C-3.0
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

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

Keywords

Cataract; Surgery, cataract extraction; Optical devices, laser

Outcome Measures

Primary Outcomes (1)

• Capsulotomy Dimension

  Capsulotomy size will be measured during surgery for both the experimental and control groups.

  Day of Surgery

Secondary Outcomes (1)

• Cumulative Dissipated Energy (CDE)

  Day of Surgery

Study Arms (2)

U/S Surgery and CCC

ACTIVE COMPARATOR

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

Procedure: U/S Surgery and CCC

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 femtosecond laser device.

Device: FS Laser Surgery

Interventions

U/S Surgery and CCC PROCEDURE

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

Also known as: Standard of care for U/S and CCC was required.

U/S Surgery and CCC

FS Laser Surgery DEVICE

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

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 20/32 (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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Optics: lead

MeSH Terms

Conditions

Cataract

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Juan F. Batlle, MD

  Laser Center

  PRINCIPAL INVESTIGATOR

• William W. Culbertson, MD

  Bascom Palmer Eye Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 10, 2014
• Study Start: April 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: February 1, 2014
• Last Updated: February 4, 2025

Record last verified: 2025-01