Clinical Trials Directory

Trials / Completed

CompletedNCT01010490

Outcomes of Phacoemulsification With Torsional Ultrasound

A Randomised Trial of Torsional Ultrasound Versus Longitudinal Ultrasound During Phacoemulsification of Age-related Cataracts: Comparison of Intra-operative Performance and Impact on Post-operative Endothelium Integrity

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
360 (actual)
Sponsor
Iladevi Cataract and IOL Research Center · Academic / Other
Sex
All
Age
55 Years – 75 Years
Healthy volunteers
Accepted

Summary

To determine the differences in intra-operative complications, surgical duration, fluid usage, corneal thickness and endothelium cell density in eyes undergoing microcoaxial phacoemulsification (MCP) either with Torsional or longitudinal ultrasound during the surgery and at post-operative day 1, 1 month and 3 months.

Detailed description

Introduced in mid 2006, torsional ultrasound (OZil, Infiniti Vision System, Alcon Laboratories, Texas, USA) uses rotational oscillations at ultrasonic frequencies to emulsify cataractous lens material in a seamless cutting motion from a tip that oscillates laterally. The side-to-side movement of the phaco tip produces minimal repulsion of lens material from the phaco tip resulting in improved followability. Clinically this translates into more effective lens removal with torsional phaco in comparison to the conventional ultrasound mode.to test this in a clinical scenario we undertook this study.

Conditions

Interventions

TypeNameDescription
PROCEDURETorsional ultrasound (INFINITI, Alcon, USA)Comparison of inta-operative efficacy and safety
PROCEDURELongitudinal U/S (Infiniti system, Alcon, USA)comparison of efficacy and safety
PROCEDURELongitudinal U/S (LEGACY 20000, Alcon, USA)Interrupted energy modality

Timeline

Start date
2007-05-01
Primary completion
2008-12-01
Completion
2009-03-01
First posted
2009-11-10
Last updated
2009-11-13

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT01010490. Inclusion in this directory is not an endorsement.