Outcomes of Phacoemulsification With Torsional Ultrasound

Cataract Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010490
• Other study ID #: 07-009
• Status: Completed
• Phase: Phase 4
• First received: November 9, 2009
• Last updated: November 11, 2009
• Start date: May 2007
• Est. completion date: March 2009

Study information

• Verified date: November 2009
• Source: Iladevi Cataract and IOL Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: March 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• Torsional ultrasound (INFINITI, Alcon, USA)
Comparison of inta-operative efficacy and safety
• Longitudinal U/S (Infiniti system, Alcon, USA)
comparison of efficacy and safety
• Longitudinal U/S (LEGACY 20000, Alcon, USA)
Interrupted energy modality

Locations

Country	Name	City	State
India	Raghudeep eye clinic	Ahmedabad	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Iladevi Cataract and IOL Research Center

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes