A Comparative Pilot Study Of High-Order Aberrations With Aspheric IOL Models SN60WF and ZCB00

Cataracts Clinical Trial

Official title:

A Comparative Pilot Study Of High-Order Aberrations With Aspheric Intraocular Lens (IOL) Models SN60WF And ZCB00

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01105585
• Other study ID #: M-09-003
• Status: Completed
• Phase: N/A
• First received: April 15, 2010
• Last updated: November 27, 2012
• Start date: April 2010

Study information

• Verified date: November 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to prospectively compare high-order aberrations between eyes implanted with the AcrySof® Natural IQ (SN60WF) intraocular lens (IOL) versus those implanted with the Tecnis ZCB00 IOL.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Requires bilateral extraction of cataracts by phacoemulsification followed by implantation of a posterior chamber intraocular lens;

• Confirmed absence of pre-existing conditions that could skew the results or present contraindications for the IQ intraocular lens (IOL) or the Tecnis ZCB00 IOL;

• <1 diopter corneal astigmatism preoperatively;

• Able to achieve 6.5 mm dilated pupil;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Chronic disease or illness;

• Irregular optical aberration;

• Amblyopia;

• History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);

• Diabetic retinopathy;

• Macular degeneration;

• History of retinal detachment;

• Other surgeries planned at time of cataract removal;

• Severe dry eye;

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataracts

Intervention

Device:
• Tecnis 1-piece Aspheric Acrylic (ZCB00) IOL
Tecnis 1-piece Aspheric Acrylic (ZCB00) intraocular lens implanted in the capsular bag during cataract surgery. The IOL is intended for the lifetime of the patient.
• AcrySof Natural IQ (SN60WF) IOL
AcrySof Natural IQ (SN60WF) intraocular lens implanted in the capsular bag during cataract surgery. The IOL is intended for the lifetime of the patient.

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total ocular high-order aberrations		Month 1 postoperative	No