Efficacy of FLACS USFREE Compared to Traditional Surgery Using Ultrasound.

NCT03050008 | Completed

• 1 other identifier: USFREE
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Cataract Surgery

Outcome Measures

Primary Outcomes (1)

• Difference in BSS volume observed between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery.

  Difference in BSS (balanced saline solution) volume observed between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery. The volume of BSS will be measured during surgery in mL, the sum of the BSS volume observed will be compared between the 2 groups. This volume will be monitored and measured by the Centurion® phacoemulsification device.

  time of surgery

Secondary Outcomes (9)

• Difference in CDE between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery.

  time of surgery

• Difference in time (in seconds) of phacoemulsification during surgery, between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery.

  time of surgery

• Difference in endothelial cell counts 1, 7 and 30 days after cataract surgery between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound.

  Within 30 days after surgery

• Difference in visual acuity presented 1, 7 and 30 days after cataract surgery between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery.

  Within 30 days after surgery

• Difference in visual acuity with best correction 1, 7 and 30 days after cataract surgery between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery.

  Within 30 days after surgery

Study Arms (2)

FLACS USFREE

OTHER

Cataract Surgery with Femtosecond Laser Without Ultrasound

Other: FLACS USFREE

Traditional Surgery

OTHER

Traditional phacoemulsification cataract surgery using ultrasound

Other: Traditional Surgery

Interventions

FLACS USFREE OTHER

Cataract Surgery with Femtosecond Laser Without Ultrasound

FLACS USFREE

Traditional Surgery OTHER

Traditional phacoemulsification cataract surgery using ultrasound.

Traditional Surgery

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of senile cataract, characterized as grade II nuclear (opacity according to Lens opacities classification system II \[LOCS II\]), in at least 1 of the eyes.
• Obtaining the informed consent form signed by the research participant and / or legal representative.

You may not qualify if:

• Cataract of degree other than II (LOCS II).
• Diabetes mellitus.
• History or presence of other ocular pathology.
• History of laser treatment (retinal or iriane).
• History of previous intraocular surgery.
• Endothelial cell count \<1500 cells / mm2.
• Corneal thickness\> 700 μm.
• Dilated pupil with a diameter of \<7.0 mm.
• Depth of the anterior chamber \<2.5 mm.
• Contraindications for cataract surgery, including: Active proliferative diabetic retinopathy; Rubeosis iridis and / or neovascular glaucoma; Microphthalmia Buftalmia; The anterior uveitis; The cornea gutatta; Glaucoma; Retinal detachment; Other systemic or concomitant diseases that, in the opinion of the investigator, prevent the surgery from being performed or can significantly bias the results.

Sponsors & Collaborators

• Alfredo Tranjan Centro Oftalmologico: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Alfredo Tranjan, MD

  Alfredo Tranjan Centro Oftalmologico LTDA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 10, 2017
• Study Start: January 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 14, 2017

Record last verified: 2017-02