Outcomes of Phacoemulsification With Torsional Ultrasound

Iladevi Cataract and IOL Research Center

Status and phase: Completed; Phase 4

Conditions: Cataract

Treatments: Procedure: Longitudinal U/S (Infiniti system, Alcon, USA); Procedure: Longitudinal U/S (LEGACY 20000, Alcon, USA); Procedure: Torsional ultrasound (INFINITI, Alcon, USA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01010490

07-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 patients

Sex: All

Ages: 55 to 75 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 3 patient groups

Torsional ultrasound

Experimental group

Description:

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

Treatment:

Procedure: Torsional ultrasound (INFINITI, Alcon, USA)

Longitudinal ultrasound (INFINITI)

Active Comparator group

Description:

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

Treatment:

Procedure: Longitudinal U/S (Infiniti system, Alcon, USA)

Longitudinal ultrasound (LEGACY)

Active Comparator group

Description:

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

Treatment:

Procedure: Longitudinal U/S (LEGACY 20000, Alcon, USA)