NCT01105585

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 16, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Last Updated

November 29, 2012

Status Verified

November 1, 2012

Enrollment Period

1.2 years

First QC Date

April 15, 2010

Last Update Submit

November 27, 2012

Conditions

Cataracts

Keywords

CataractsasphericIOLocular aberrations

Outcome Measures

Primary Outcomes (1)

  • Total ocular high-order aberrations

    Month 1 postoperative

Study Arms (2)

ZCB00 IOL

EXPERIMENTAL

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

Device: Tecnis 1-piece Aspheric Acrylic (ZCB00) IOL

SN60WF IOL

ACTIVE COMPARATOR

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

Device: AcrySof Natural IQ (SN60WF) IOL

Interventions

Tecnis 1-piece Aspheric Acrylic (ZCB00) IOLDEVICE

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.

ZCB00 IOL
AcrySof Natural IQ (SN60WF) IOLDEVICE

AcrySof Natural IQ (SN60WF) intraocular lens implanted in the capsular bag during cataract surgery. The IOL is intended for the lifetime of the patient.

SN60WF IOL

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2010

First Posted

April 16, 2010

Study Start

April 1, 2010

Primary Completion

June 1, 2011

Last Updated

November 29, 2012

Record last verified: 2012-11

Locations

US(1)