Comparison of the Performance of the Infiniti Vision and the Series 20000 Legacy Phacoemulsification Systems

Cataract Extraction Clinical Trial

Official title:

Comparison of the Infiniti Vision and the Series 20000 Legacy Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366665
• Other study ID #: MRC-05-002
• Status: Completed
• Phase: N/A
• First received: August 17, 2006
• Last updated: August 17, 2006
• Start date: March 2005
• Est. completion date: May 2005

Study information

• Verified date: May 2005
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To compare the efficiency of the Infiniti vision system and the Series 20000 Legacy System phacoemulsification units during routine cataract extraction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Cataract

• Eligible for cataract extraction with primary implantation of a posterior chamber IOL

• 2 to 3+ cataract density

Exclusion Criteria:

• Preoperative ocular pathology that can affect visual acuity

• Corneal irregularities such as keratoconus, corneal dystrophy, corneal opacities.

• Previous intraocular or corneal surgery.

• Other ocular surgery at the time of the cataract extraction.

• Surgical Exclusion Criteria:

• Significant intraoperative intraocular bleeding

• Detached Descemet’s membrane

• Implantation of the intraocular lens in the anterior chamber or sulcus

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract Extraction

Intervention

Device:
• Legacy 20000

• Infinit system

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound time
Primary	Amount of fluid used
Primary	Post operative visual acuity.