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Trial record 8 of 115 for:    centurion

Efficacy of FLACS USFREE Compared to Traditional Surgery Using Ultrasound. (USFREE)

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ClinicalTrials.gov Identifier: NCT03050008
Recruitment Status : Completed
First Posted : February 10, 2017
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):
Alfredo Tranjan Centro Oftalmologico

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.

Condition or disease Intervention/treatment Phase
Senile Cataract Cataract Other: FLACS USFREE Other: Traditional Surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Controlled Trial in Patients With Senile Cataract to Evaluate the Efficacy of Ultrasound-free Femtosecond Laser (FLACS) Cataract Surgery (USFREE), Compared to Traditional Phacoemulsification Surgery Using Ultrasound.
Study Start Date : January 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Ultrasound

Arm Intervention/treatment
FLACS USFREE
Cataract Surgery with Femtosecond Laser Without Ultrasound
Other: FLACS USFREE
Cataract Surgery with Femtosecond Laser Without Ultrasound

Traditional Surgery
Traditional phacoemulsification cataract surgery using ultrasound
Other: Traditional Surgery
Traditional phacoemulsification cataract surgery using ultrasound.




Primary Outcome Measures :
  1. Difference in BSS volume observed between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery. [ Time Frame: time of 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.



Secondary Outcome Measures :
  1. Difference in CDE between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery. [ Time Frame: time of surgery ]

    Cumulative dissipated energy is an estimate of the energy used at the incision site during cataract removal and is measured automatically by the Centurion® device in% -seconds. Lower value reflects less energy used, being considered more favorable for the safety of the corneal endothelium.

    For surgeries that occurred according to the first version of this protocol (03-Nov-2015) the CDE data contained in the source documents will be used, , since this is a data already collected during both procedures.


  2. Difference in time (in seconds) of phacoemulsification during surgery, between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery. [ Time Frame: time of surgery ]
    Phacoemulsification time is measured automatically by Centurion®, and expressed in minutes and seconds.

  3. Difference in endothelial cell counts 1, 7 and 30 days after cataract surgery between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound. [ Time Frame: Within 30 days after surgery ]
    The endothelial cell count will be performed in each eye at V1, V1, V2 and V3 (and V5, V6 and V7 for O2) using SP02® specular microscope (CSO, Italy).

  4. 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. [ Time Frame: 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.

  5. 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. [ Time Frame: Within 30 days after surgery ]

    The visual acuity presented and best corrected will be measured in V-1, V1, V2 and V3 for each eye (and V5, V6 and V7 for O2).

    Assessment of visual acuity in the distance (4 m) will be performed with the standardized and backlit LogMAR table. All exams for this study will be performed with the same equipment and lighting conditions. Research participants will be asked to read the smaller line whose letters are easily distinguishable. Survey participants will continue to read lines with smaller and smaller letters until the survey participant misses all the letters or can not guess any of them. While the survey participant reads the table, the number of letters read incorrectly will be recorded on each line. In this study, the LogMAR of the presented visual acuity and the visual acuity with better correction will be obtained.


  6. Difference in corneal topography 1, 7 and 30 days after cataract surgery between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery. [ Time Frame: Within 30 days after surgery ]
    Simulated keratometry (Yes K) will be measured in each eye at V-1, V1, V2 and V3 (and V5, V6 and V7 for O2) using the Pentacam® system (OCULUS, WA, USA). The Pentacam® system will use a rotating Scheimpflug camera to produce a three-dimensional analysis of the anterior segment of the cornea. A Sim K will be obtained by averaging the power of the anterior surface of the cornea along a 3 mm center ring, measured in diopters (D). In order to minimize bias, measurements will always be made on the same device, with the same operator or their back-up, both with the same training.

  7. Difference in corneal pachymetry 1, 7 and 30 days after cataract surgery, between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery. [ Time Frame: Within 30 days after surgery ]
    In this examination, the pachymeter will be placed in front of the eye to measure the thickness of the cornea, which will be recorded in mm. This analysis will be done in V-1, V1, V2 and V3 (and V5, V6 and V7 for O2). In order to minimize bias, measurements will always be made on the same device, with the same operator or their back-up, both with the same training.

  8. Difference in intraocular pressure 1, 7 and 30 days after cataract surgery between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery. [ Time Frame: Within 30 days after surgery ]
    Intraocular pressure will be measured in each eye at V-1, V1, V2 and V3 (and V5, V6 and V7 for O2) using the Goldmann aplanation tonometer (Haag-Streit Diagnostics, Switzerland). The intraocular pressure will be measured in mmHg. In order to minimize bias, measurements will always be made on the same device, with the same operator or their back-up, both with the same training.

  9. Incidence of adverse events during the study period among study participants submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound. [ Time Frame: Within 30 days after surgery ]
    Adverse events will be gathered for each eye and each research participant



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050008


Sponsors and Collaborators
Alfredo Tranjan Centro Oftalmologico
Investigators
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Principal Investigator: Alfredo Tranjan, MD Alfredo Tranjan Centro Oftalmologico LTDA

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Responsible Party: Alfredo Tranjan Centro Oftalmologico
ClinicalTrials.gov Identifier: NCT03050008     History of Changes
Other Study ID Numbers: USFREE
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Information not yet provided.

Keywords provided by Alfredo Tranjan Centro Oftalmologico:
Cataract Surgery

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases