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Parameters of 2 Phaco Tips Designs in Torsional Phacoemulsification

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ClinicalTrials.gov Identifier: NCT02089698
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : March 18, 2014
Sponsor:
Information provided by (Responsible Party):
PATRICK FRENSEL DE MORAES TZELIKIS, Hospital Oftalmologico de Brasilia

Study Description
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Brief Summary:
To compare the efficiency of surgical procedures using 2 phaco tip designs in torsional phacoemulsification using the bevel-down technique.

Condition or disease Intervention/treatment Phase
Cataract Device: Mini-flared Device: Reversed tip Phase 4

Detailed Description:

In this prospective, comparative, masked study, patients will be randomly assigned to have torsional coaxial microincision cataract surgery using either the mini-flared 45-degree Kelman tip or reversed mini-flared 30-degree Kelman tip. Clinical measurements will include preoperative and 3-month postoperative corrected distance visual acuity (CDVA), endothelial cell counts (ECC) and preoperative and 1-day postoperative central corneal thickness (CCT). Intraoperative measurements will include phaco time, torsional time, aspiration time, case time, cumulative dissipated energy (CDE) and balanced salt solution volume (BSS).

The study was performed according to established ethical standards for clinical research Institutional Review Board (IRB) of the University of Sao Paulo in Brazil, conducted between November 2010 and February of 2011. All surgeries will be performed at the University of Sao Paulo. Physicians conducting postoperative evaluation will not have access to patients' medical records. Exclusion criteria will be previous ocular surgery, central endothelial cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmHg, amblyopia, retinal abnormalities, steroid or immunosuppressive treatment and connective tissue diseases. Enrolled patients who have complicated cataract surgery (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) will be subsequently excluded.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Mini-flared Kelman Tip and Reverse Tip With Torsional Phaco: Prospective Randomized Comparative Study
Study Start Date : September 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Reversed tip
Reversed Kelman tip
 Device: Mini-flared
Mini-flared Kelman tip
Experimental: Mini-flared
Mini-flared Kelman tip
 Device: Reversed tip
Reversed Kelman tip


Outcome Measures
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Primary Outcome Measures :
  1. Early Treatment Diabetic Retinopathy (ETDRS) visual acuities [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Phaco time used [ Time Frame: 1 day, 90 days ]

Other Outcome Measures:
  1. Cumulative dissipated energy (CDE) required [ Time Frame: 1 day, 90 days ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients older than 40 years with age-related cataract, and a normal ophthalmologic examination besides senile cataract.

Exclusion Criteria:

  • Previous ocular surgery, central endothelial cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmHg, amblyopia, retinal abnormalities, steroid or immunosuppressive treatment, connective tissue diseases, or an allergy or hypersensitivity to NSAIDs. Enrolled patients who had complicated cataract surgery (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) were subsequently excluded
Contacts and Locations
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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): NCT02089698


Locations
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Brazil
Hospital Oftalmologico de Brasília
Brasilia, DF, Brazil, 70000
Sponsors and Collaborators
Hospital Oftalmologico de Brasilia
Investigators
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Principal Investigator: Patrick F Tzelikis, MD, PhD Hospital Oftalmologico de Brasilia
More Information
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Publications of Results:

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Responsible Party: PATRICK FRENSEL DE MORAES TZELIKIS, Principal Investigator, Hospital Oftalmologico de Brasilia
ClinicalTrials.gov Identifier: NCT02089698    
Other Study ID Numbers: 2014.03
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014
Keywords provided by PATRICK FRENSEL DE MORAES TZELIKIS, Hospital Oftalmologico de Brasilia:
Kelman tip
Mini-flared
phacoemulsification
cataract
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases