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Outcomes of Phacoemulsification With Torsional Ultrasound

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

Condition Intervention Phase
Procedure: Torsional ultrasound (INFINITI, Alcon, USA)
Procedure: Longitudinal U/S (Infiniti system, Alcon, USA)
Procedure: Longitudinal U/S (LEGACY 20000, Alcon, USA)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Iladevi Cataract and IOL Research Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 360
Study Start Date: May 2007
Study Completion Date: March 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Torsional ultrasound
Torsional ultrasound with the INFINITI phacoemulsification system (Alcon Lab, USA)
Procedure: Torsional ultrasound (INFINITI, Alcon, USA)
Comparison of inta-operative efficacy and safety
Other Name: OZIL technology
Active Comparator: Longitudinal ultrasound (INFINITI)
Longitudinal ultrasound with the INFINITI phacomachine (Alcon Lab, USA)
Procedure: Longitudinal U/S (Infiniti system, Alcon, USA)
comparison of efficacy and safety
Other Name: traditional ultrasound
Active Comparator: Longitudinal ultrasound (LEGACY)
Longitudinal ultrasound with the LEGACY phacomachine (Alcon Lab, USA)
Procedure: Longitudinal U/S (LEGACY 20000, Alcon, USA)
Interrupted energy modality
Other Name: Traditional U/S

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 test this in a clinical scenario we undertook this study.

Ages Eligible for Study:   55 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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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Please refer to this study by its identifier: NCT01010490

Raghudeep eye clinic
Ahmedabad, Gujarat, India, 52
Sponsors and Collaborators
Iladevi Cataract and IOL Research Center
Principal Investigator: shetal m raj, ms Iladevi Cataract and IOL Research Center
  More Information

Responsible Party: Dr. Shetal Raj, Raghudeep eye clinic Identifier: NCT01010490     History of Changes
Other Study ID Numbers: 07-009
Study First Received: November 9, 2009
Last Updated: November 11, 2009

Keywords provided by Iladevi Cataract and IOL Research Center:
Intraoperative complications

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 25, 2017