Outcomes of Phacoemulsification With Torsional Ultrasound

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cataract

Intervention / Treatment
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* Procedure: Torsional ultrasound (INFINITI, Alcon, USA)
* Procedure: Longitudinal U/S (Infiniti system, Alcon, USA)
* Procedure: Longitudinal U/S (LEGACY 20000, Alcon, USA)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Torsional ultrasound<br>Torsional ultrasound with the INFINITI phacoemulsification system (Alcon Lab, USA) | Procedure: Torsional ultrasound (INFINITI, Alcon, USA)<br>* Comparison of inta-operative efficacy and safety<br>* Other names: OZIL technology;|
| Active Comparator: Longitudinal ultrasound (INFINITI)<br>Longitudinal ultrasound with the INFINITI phacomachine (Alcon Lab, USA) | Procedure: Longitudinal U/S (Infiniti system, Alcon, USA)<br>* comparison of efficacy and safety<br>* Other names: traditional ultrasound;|
| Active Comparator: Longitudinal ultrasound (LEGACY)<br>Longitudinal ultrasound with the LEGACY phacomachine (Alcon Lab, USA) | Procedure: Longitudinal U/S (LEGACY 20000, Alcon, USA)<br>* Interrupted energy modality<br>* Other names: Traditional U/S;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 3 months post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PACHYMETRY, CELL LOSS, SAFETY, EFFICACY, PHACOEMULSIFICATION, Intraoperative complications, CLOCK TIME, FLUID USED, CORNEAL THICKNESS, ENDOTHELIUM CELL LOSS