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

NCT01069172 | Completed Phase 3 Results

• 1 other identifier: OMC-C-2.0
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract

Keywords

Cataract; Surgery, cataract extraction; Optical devices, laser

Outcome Measures

Primary Outcomes (1)

• Deviation From Intended Capsulotomy Diameter

  Capsulotomy diameter 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)

FS Laser Surgery

EXPERIMENTAL

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.

Device: FS Laser Surgery

CCC Surgery

ACTIVE COMPARATOR

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.

Procedure: CCC Surgery

Interventions

FS Laser Surgery DEVICE

The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery to perform capsulotomy, lens segmentation, and lens softening, which are all part of cataract surgery when this femtosecond laser is used.

Also known as: OptiMedica Catalys™ Precision Laser System (Catalys System) = femtosecond laser; Alcon Infiniti System = U/S (ultrasound) phacoemulsification system

FS Laser Surgery

CCC Surgery PROCEDURE

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

Also known as: Alcon Infiniti System = U/S (ultrasound) phacoemulsification system.

CCC 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 (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

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

Study Sites (1)

Laser Center

Santo Domingo, Dominican Republic

Location

MeSH Terms

Conditions

Cataract

Interventions

Ultrasonography; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Limitations and Caveats

This evaluation was performed on a relatively small number of patients; assessment of CDE should be repeated in a larger number of subjects.

Results Point of Contact

• Title: Luis Atiles, Manager, Clinical Research
• Organization: AMO Development, LLC

luis.atiles@amo.abbott.com

214 537-6784

Study Officials

• Juan F Batlle, MD

  Laser Center

  PRINCIPAL INVESTIGATOR

• William W Culberston, MD

  Bascom Palmer Eye Institute

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: February 13, 2010
• First Posted: February 17, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: September 4, 2014
• Results First Posted: September 4, 2014

Record last verified: 2014-08

Locations

DO (1)