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

NCT01069172 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-09-04

Study results available
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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

Interventions

DEVICE

FS Laser Surgery

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.

PROCEDURE

CCC Surgery

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.

Sponsors & Collaborators

  • Abbott Medical Optics

    lead INDUSTRY

Principal Investigators

  • Juan F Batlle, MD · Laser Center

  • William W Culberston, MD · Bascom Palmer Eye Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-07-31
Completion
2010-08-31

Countries

  • Dominican Republic

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01069172 on ClinicalTrials.gov