- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01010490
Outcomes of Phacoemulsification With Torsional Ultrasound
November 11, 2009 updated by: Iladevi Cataract and IOL Research Center
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
360
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gujarat
-
Ahmedabad, Gujarat, India, 52
- Raghudeep Eye Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
53 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Torsional ultrasound
Torsional ultrasound with the INFINITI phacoemulsification system (Alcon Lab, USA)
|
Comparison of inta-operative efficacy and safety
Other Names:
|
Active Comparator: Longitudinal ultrasound (INFINITI)
Longitudinal ultrasound with the INFINITI phacomachine (Alcon Lab, USA)
|
comparison of efficacy and safety
Other Names:
|
Active Comparator: Longitudinal ultrasound (LEGACY)
Longitudinal ultrasound with the LEGACY phacomachine (Alcon Lab, USA)
|
Interrupted energy modality
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 months post-operative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: shetal m raj, ms, Iladevi Cataract and IOL Research Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
November 9, 2009
First Submitted That Met QC Criteria
November 9, 2009
First Posted (Estimate)
November 10, 2009
Study Record Updates
Last Update Posted (Estimate)
November 13, 2009
Last Update Submitted That Met QC Criteria
November 11, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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