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
  Purpose

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
Cataract
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
Endpoint Classification: Bio-equivalence Study
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 ] [ Designated as safety issue: Yes ]

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 mode.to test this in a clinical scenario we undertook this study.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010490

Locations
India
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
  More Information

Publications:
Responsible Party: Dr. Shetal Raj, Raghudeep eye clinic
ClinicalTrials.gov Identifier: NCT01010490     History of Changes
Other Study ID Numbers: 07-009
Study First Received: November 9, 2009
Last Updated: November 11, 2009
Health Authority: India: Institutional Review Board

Keywords provided by Iladevi Cataract and IOL Research Center:
PACHYMETRY
CELL LOSS
SAFETY
EFFICACY
PHACOEMULSIFICATION
Intraoperative complications
CLOCK TIME
FLUID USED
CORNEAL THICKNESS
ENDOTHELIUM CELL LOSS

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Dipivefrin
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014