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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01010490

Enrollment

360

Registered

2009-11-10

Start date

2007-05-31

Completion date

2009-03-31

Last updated

2009-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

PACHYMETRY, CELL LOSS, SAFETY, EFFICACY, PHACOEMULSIFICATION, Intraoperative complications, CLOCK TIME, FLUID USED, CORNEAL THICKNESS, ENDOTHELIUM CELL LOSS

Brief 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.

Interventions

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

55 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Intra-operative complications, surgical clock time in minutes (SCT), fluid volume in ml(FV), and central corneal thickness in µm (CCT) on day 1 and months 1 and 3, and endothelial cell density (ECD) at 3 months.	3 months post-operative

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026