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Completed

NCT Number: NCT02089698

Parameters of 2 Phaco Tips Designs in Torsional Phacoemulsification

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

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Oftalmologico de Brasília

Brasília, Federal District, 70000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mini-flared

Device

Mini-flared Kelman tip

Reversed tip

Device

Reversed Kelman tip

Primary outcomes

  1. Early Treatment Diabetic Retinopathy (ETDRS) visual acuities

    Time frame: 90 days

Secondary outcomes

  1. Phaco time used

    Time frame: 1 day, 90 days

Other outcomes

  1. Cumulative dissipated energy (CDE) required

    Time frame: 1 day, 90 days

Sponsors and collaborators

Lead sponsor

Hospital Oftalmologico de Brasilia

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Mar 18, 2014
Registry last updated
Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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