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

Primary Purpose

Cataracts

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tecnis 1-piece Aspheric Acrylic (ZCB00) IOL
AcrySof Natural IQ (SN60WF) IOL
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataracts focused on measuring Cataracts, aspheric, IOL, ocular aberrations

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Contact Alcon Call Center for Trial Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ZCB00 IOL

SN60WF IOL

Arm Description

Tecnis 1-piece Aspheric Acrylic (ZCB00) intraocular lens (IOL) randomly assigned to one eye, with AcrySof Natural IQ (SN60WF) IOL in the fellow eye for contralateral implantation

AcrySof Natural IQ (SN60WF) intraocular lens (IOL) randomly assigned to one eye, with Tecnis 1-piece Aspheric Acrylic (ZCB00) intraocular lens in the fellow eye for contralateral implantation

Outcomes

Primary Outcome Measures

Total ocular high-order aberrations

Secondary Outcome Measures

Full Information

First Posted
April 15, 2010
Last Updated
November 27, 2012
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT01105585
Brief Title
A Comparative Pilot Study Of High-Order Aberrations With Aspheric IOL Models SN60WF and ZCB00
Official Title
A Comparative Pilot Study Of High-Order Aberrations With Aspheric Intraocular Lens (IOL) Models SN60WF And ZCB00
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts
Keywords
Cataracts, aspheric, IOL, ocular aberrations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ZCB00 IOL
Arm Type
Experimental
Arm Description
Tecnis 1-piece Aspheric Acrylic (ZCB00) intraocular lens (IOL) randomly assigned to one eye, with AcrySof Natural IQ (SN60WF) IOL in the fellow eye for contralateral implantation
Arm Title
SN60WF IOL
Arm Type
Active Comparator
Arm Description
AcrySof Natural IQ (SN60WF) intraocular lens (IOL) randomly assigned to one eye, with Tecnis 1-piece Aspheric Acrylic (ZCB00) intraocular lens in the fellow eye for contralateral implantation
Intervention Type
Device
Intervention Name(s)
Tecnis 1-piece Aspheric Acrylic (ZCB00) IOL
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
AcrySof Natural IQ (SN60WF) IOL
Intervention Description
AcrySof Natural IQ (SN60WF) intraocular lens implanted in the capsular bag during cataract surgery. The IOL is intended for the lifetime of the patient.
Primary Outcome Measure Information:
Title
Total ocular high-order aberrations
Time Frame
Month 1 postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Contact Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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