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OpenTrials
Completed

NCT Number: NCT01010490

Outcomes of Phacoemulsification With Torsional Ultrasound

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.

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Key information

Conditions

Cataract Eye Diseases Intraoperative Complications Lens Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Raghudeep eye clinic

Ahmedabad, Gujarat, 52, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Torsional ultrasound (INFINITI, Alcon, USA)

Procedure

Comparison of inta-operative efficacy and safety

Other names: OZIL technology

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

Procedure

comparison of efficacy and safety

Other names: traditional ultrasound

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

Procedure

Interrupted energy modality

Other names: Traditional U/S

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Iladevi Cataract and IOL Research Center

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Nov 10, 2009
Registry last updated
Nov 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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