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Outcomes of Phacoemulsification With Torsional Ultrasound

Sponsor
Iladevi Cataract and IOL Research Center (Other)
Overall Status
Completed
CT.gov ID
NCT01010490
Collaborator
(none)
360
Enrollment
1
Location
3
Arms
22
Duration (Months)
16.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment 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

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (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
Study Start Date :
May 1, 2007
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Mar 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • Traditional U/S

    		•

    Outcome Measures

    Primary Outcome Measures

    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. [3 months post-operative]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 75 Years
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Raghudeep eye clinic Ahmedabad Gujarat India 52

    Sponsors and Collaborators

    • Iladevi Cataract and IOL Research Center

    Investigators

    • Principal Investigator: shetal m raj, ms, Iladevi Cataract and IOL Research Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01010490
    Other Study ID Numbers:
    • 07-009
    First Posted:
    Nov 10, 2009
    Last Update Posted:
    Nov 13, 2009
    Last Verified:
    Nov 1, 2009
    Keywords provided by , ,
    PACHYMETRY
    CELL LOSS
    SAFETY
    EFFICACY
    PHACOEMULSIFICATION
    Intraoperative complications
    CLOCK TIME
    FLUID USED
    CORNEAL THICKNESS
    ENDOTHELIUM CELL LOSS
    Additional relevant MeSH terms:
    Cataract
    Dipivefrin

    Study Results

    No Results Posted as of Nov 13, 2009