Parameters of 2 Phaco Tips Designs in Torsional Phacoemulsification

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

Detailed Description
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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.

Official Title
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Mini-flared Kelman Tip and Reverse Tip With Torsional Phaco: Prospective Randomized Comparative Study

Conditions
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Cataract

Intervention / Treatment
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* Device: Mini-flared
* Device: Reversed tip


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reversed tip<br>Reversed Kelman tip | Device: Mini-flared<br>* Mini-flared Kelman tip<br>|
| Experimental: Mini-flared<br>Mini-flared Kelman tip | Device: Reversed tip<br>* Reversed Kelman tip<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Treatment Diabetic Retinopathy (ETDRS) visual acuities |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phaco time used |  | 1 day, 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kelman tip, Mini-flared, phacoemulsification, cataract