Outcomes of Phacoemulsification With Torsional Ultrasound

This study has been completed.
Sponsor:
Information provided by:
Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier:
NCT01010490
First received: November 9, 2009
Last updated: November 11, 2009
Last verified: November 2009

November 9, 2009
November 11, 2009
May 2007
December 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01010490 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Cataract
  • Procedure: Torsional ultrasound (INFINITI, Alcon, USA)
    Comparison of inta-operative efficacy and safety
    Other Name: OZIL technology
  • Procedure: Longitudinal U/S (Infiniti system, Alcon, USA)
    comparison of efficacy and safety
    Other Name: traditional ultrasound
  • Procedure: Longitudinal U/S (LEGACY 20000, Alcon, USA)
    Interrupted energy modality
    Other Name: Traditional U/S
  • Experimental: Torsional ultrasound
    Torsional ultrasound with the INFINITI phacoemulsification system (Alcon Lab, USA)
    Intervention: Procedure: Torsional ultrasound (INFINITI, Alcon, USA)
  • Active Comparator: Longitudinal ultrasound (INFINITI)
    Longitudinal ultrasound with the INFINITI phacomachine (Alcon Lab, USA)
    Intervention: Procedure: Longitudinal U/S (Infiniti system, Alcon, USA)
  • Active Comparator: Longitudinal ultrasound (LEGACY)
    Longitudinal ultrasound with the LEGACY phacomachine (Alcon Lab, USA)
    Intervention: Procedure: Longitudinal U/S (LEGACY 20000, Alcon, USA)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
March 2009
December 2008   (final data collection date for primary outcome measure)

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.
Both
55 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01010490
07-009
Yes
Dr. Shetal Raj, Raghudeep eye clinic
Iladevi Cataract and IOL Research Center
Not Provided
Principal Investigator: shetal m raj, ms Iladevi Cataract and IOL Research Center
Iladevi Cataract and IOL Research Center
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP