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Efficacy of FLACS USFREE Compared to Traditional Surgery Using Ultrasound.

NCT03050008 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2017-02-14

No results posted yet for this study

Summary

Despite the advantages already demonstrated by FLACS, these surgeries still require ultrasonic devices for fragmentation of the lens. The ultrasonic energy used during phacoemulsification may induce complications such as reduction of endothelial cells and corneal edema. In this sense, it would be beneficial to develop surgical techniques that eliminate the need for ultrasound. The group of surgeons of Alfredo Tranjan Ophthalmic Center, recently developed a surgical technique of cataract that optimizes the use of the laser, eliminating the need for ultrasound during the surgical procedure. Thus, the crystalline fragmentation process does not involve ultrasound being performed by the laser itself. It is expected that this procedure will reduce the complexity of cataract surgery, and be safer in terms of potential corneal lesions. The present study intends to evaluate the benefit and safety of FLACS without use of ultrasound (USFREE), compared to traditional phacoemulsification surgery using ultrasound in patients with senile cataract. In this sense, it is intended to primarily compare the volume of balanced saline solution (BSS) between surgeries.

Conditions

  • Senile Cataract
  • Cataract

Interventions

OTHER

FLACS USFREE

Cataract Surgery with Femtosecond Laser Without Ultrasound

OTHER

Traditional Surgery

Traditional phacoemulsification cataract surgery using ultrasound.

Sponsors & Collaborators

  • Alfredo Tranjan Centro Oftalmologico

    lead OTHER

Principal Investigators

  • Alfredo Tranjan, MD · Alfredo Tranjan Centro Oftalmologico LTDA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-11-30
Completion
2016-11-30

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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 NCT03050008 on ClinicalTrials.gov