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CompletedNCT01010490Updated Nov 13, 2009

Outcomes of Phacoemulsification With Torsional Ultrasound

A Phase 4 interventional study of Torsional ultrasound (INFINITI, Alcon, USA) and Longitudinal U/S (Infiniti system, Alcon, USA) in Cataract, sponsored by Iladevi Cataract and IOL Research Center. Completed at 1 site in India. Open to participants aged 55 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-11-13.

Sponsored by Iladevi Cataract and IOL Research Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
55 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cataract

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Keywords

  • PACHYMETRY
  • CELL LOSS
  • SAFETY
  • EFFICACY
  • PHACOEMULSIFICATION
  • Intraoperative complications
  • CLOCK TIME
  • FLUID USED
  • CORNEAL THICKNESS
  • ENDOTHELIUM CELL LOSS
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 360 is above the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Iladevi Cataract and IOL Research Center is the lead sponsor of 20 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 75 Years
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
360 participants (actual)

Study arms

  • Experimental
    Torsional ultrasound

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

    Procedure: Torsional ultrasound (INFINITI, Alcon, USA)

  • Active comparator
    Longitudinal ultrasound (INFINITI)

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

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

  • Active comparator
    Longitudinal ultrasound (LEGACY)

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

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

Interventions

  • ProcedureTorsional ultrasound (INFINITI, Alcon, USA)

    Comparison of inta-operative efficacy and safety

    Also known as: OZIL technology

  • ProcedureLongitudinal U/S (Infiniti system, Alcon, USA)

    comparison of efficacy and safety

    Also known as: traditional ultrasound

  • ProcedureLongitudinal U/S (LEGACY 20000, Alcon, USA)

    Interrupted energy modality

    Also known as: Traditional U/S

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months post-operative

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Study locations

1 site
  • Raghudeep eye clinic
    Ahmedabad, Gujarat 52, India
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References and documents

Publications

  • Liu Y, Zeng M, Liu X, Luo L, Yuan Z, Xia Y, Zeng Y. Torsional mode versus conventional ultrasound mode phacoemulsification: randomized comparative clinical study. J Cataract Refract Surg. 2007 Feb;33(2):287-92. doi: 10.1016/j.jcrs.2006.10.044. PubMed 17276271 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01010490
Lead sponsor
Iladevi Cataract and IOL Research Center
First posted
Nov 10, 2009
Start date
May 2007
Primary completion
Dec 2008
Completion
Mar 2009
Last update
Nov 13, 2009

Study contacts

shetal m raj, ms
principal investigator · Iladevi Cataract and IOL Research Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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