Outcomes of Phacoemulsification With Torsional Ultrasound

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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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

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Torsional ultrasound

Torsional ultrasound with the INFINITI phacoemulsification system (Alcon Lab, USA)

Group Type EXPERIMENTAL

Torsional ultrasound (INFINITI, Alcon, USA)

Intervention Type PROCEDURE

Comparison of inta-operative efficacy and safety

Longitudinal ultrasound (INFINITI)

Longitudinal ultrasound with the INFINITI phacomachine (Alcon Lab, USA)

Group Type ACTIVE_COMPARATOR

Longitudinal U/S (Infiniti system, Alcon, USA)

Intervention Type PROCEDURE

comparison of efficacy and safety

Longitudinal ultrasound (LEGACY)

Longitudinal ultrasound with the LEGACY phacomachine (Alcon Lab, USA)

Group Type ACTIVE_COMPARATOR

Longitudinal U/S (LEGACY 20000, Alcon, USA)

Intervention Type PROCEDURE

Interrupted energy modality

Interventions

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Torsional ultrasound (INFINITI, Alcon, USA)

Comparison of inta-operative efficacy and safety

Intervention Type PROCEDURE

Longitudinal U/S (Infiniti system, Alcon, USA)

comparison of efficacy and safety

Intervention Type PROCEDURE

Longitudinal U/S (LEGACY 20000, Alcon, USA)

Interrupted energy modality

Intervention Type PROCEDURE

Other Intervention Names

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OZIL technology traditional ultrasound Traditional U/S

Eligibility Criteria

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Inclusion Criteria

* patients 55 years and older with a senile cataract grades 1 to 5 nuclear sclerosis based on Emery's classification,
* endothelial cell density \> 1500 cells/mm2,
* anterior chamber depth \> 2.4 mm, and
* a dilated pupil \> 7 mm.

Exclusion Criteria

* eyes with pseudoexfoliation,
* mature, traumatic, or complicated cataracts,
* history of previous intra-ocular surgery, glaucoma, uveitis, and
* patients who were unable to comply with follow-up examinations.

Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes