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Outcomes of Phacoemulsification With Torsional Ultrasound

Primary Purpose

Cataract

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Torsional ultrasound (INFINITI, Alcon, USA)
Longitudinal U/S (Infiniti system, Alcon, USA)
Longitudinal U/S (LEGACY 20000, Alcon, USA)
Sponsored by
Iladevi Cataract and IOL Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring PACHYMETRY, CELL LOSS, SAFETY, EFFICACY, PHACOEMULSIFICATION, Intraoperative complications, CLOCK TIME, FLUID USED, CORNEAL THICKNESS, ENDOTHELIUM CELL LOSS

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Raghudeep eye clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Torsional ultrasound

Longitudinal ultrasound (INFINITI)

Longitudinal ultrasound (LEGACY)

Arm Description

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

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

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

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
November 9, 2009
Last Updated
November 11, 2009
Sponsor
Iladevi Cataract and IOL Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01010490
Brief Title
Outcomes of Phacoemulsification With Torsional Ultrasound
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 Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Iladevi Cataract and IOL Research Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
PACHYMETRY, CELL LOSS, SAFETY, EFFICACY, PHACOEMULSIFICATION, Intraoperative complications, CLOCK TIME, FLUID USED, CORNEAL THICKNESS, ENDOTHELIUM CELL LOSS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Torsional ultrasound
Arm Type
Experimental
Arm Description
Torsional ultrasound with the INFINITI phacoemulsification system (Alcon Lab, USA)
Arm Title
Longitudinal ultrasound (INFINITI)
Arm Type
Active Comparator
Arm Description
Longitudinal ultrasound with the INFINITI phacomachine (Alcon Lab, USA)
Arm Title
Longitudinal ultrasound (LEGACY)
Arm Type
Active Comparator
Arm Description
Longitudinal ultrasound with the LEGACY phacomachine (Alcon Lab, USA)
Intervention Type
Procedure
Intervention Name(s)
Torsional ultrasound (INFINITI, Alcon, USA)
Other Intervention Name(s)
OZIL technology
Intervention Description
Comparison of inta-operative efficacy and safety
Intervention Type
Procedure
Intervention Name(s)
Longitudinal U/S (Infiniti system, Alcon, USA)
Other Intervention Name(s)
traditional ultrasound
Intervention Description
comparison of efficacy and safety
Intervention Type
Procedure
Intervention Name(s)
Longitudinal U/S (LEGACY 20000, Alcon, USA)
Other Intervention Name(s)
Traditional U/S
Intervention Description
Interrupted energy modality
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shetal m raj, ms
Organizational Affiliation
Iladevi Cataract and IOL Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Raghudeep eye clinic
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
52
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
17276271
Citation
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.
Results Reference
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Outcomes of Phacoemulsification With Torsional Ultrasound

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