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Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL

Primary Purpose

Cataract

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

AcrySof® IQ IOL

Tecnis® Aspheric intraocular lens

Akreos® MI60 intraocular lens

About this trial

This is an interventional treatment trial for Cataract focused on measuring cataract, intraocular lens

Eligibility Criteria

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

Inclusion Criteria:

Male or female subjects, aged 50 and over.
Subjects diagnosed with bilateral cataracts requiring cataract extraction and implantation of a posterior chamber intraocular lens.
Subjects must be willing to undertake the additional ophthalmic tests within 3 months of the second lens implantation.
Subjects must be assessed to be able to dilate to a minimum of 6 mm pre operatively.
Subjects' pupil size must be ≥ 4.5 mm in mesopic conditions.

Exclusion Criteria:

Subjects who have previously had corneal surgery.
Subjects who have potential visual acuity which is < 6/12 due to other ocular pathology
Subjects with corneal pathology.
Subjects with astigmatism of greater than 1D.
Subjects diagnosed with glaucoma.
Subjects diagnosed with diabetes.
Subjects who have previously participated in a clinical investigation within 30 days prior to enrolment
Subjects with a know history of poor compliance
Subjects with planned adjunctive surgery

Sites / Locations

Alcon Call Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

AcrySof® IQ intraocular lens

Tecnis® Aspheric intraocular lens

Akreos® MI60 intraocular lens

Outcomes

Primary Outcome Measures

Contrast sensitivity

Secondary Outcome Measures

Visual acuity, contrast acuity, wavefront analysis, corneal spherical aberration, manifest refraction.

Full Information

NCT ID

NCT00760058

First Posted

September 24, 2008

Last Updated

May 8, 2015

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT00760058

Brief Title

Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL

Official Title

Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Withdrawn

Why Stopped

Enrollment not initiated for study.

Study Start Date

June 2008 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of the study is to compare the visual outcomes of three aspheric monofocal intraocular lenses after cataract surgery - ACRYSOF® IQ, Tecnis® and Akreos® MI60.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

Keywords

cataract, intraocular lens

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

AcrySof® IQ intraocular lens

Arm Title

Arm Type

Active Comparator

Arm Description

Tecnis® Aspheric intraocular lens

Arm Title

Arm Type

Active Comparator

Arm Description

Akreos® MI60 intraocular lens

Intervention Type

Device

Intervention Name(s)

AcrySof® IQ IOL

Intervention Description

Replacement of natural crystalline lens in cataract surgery

Intervention Type

Device

Intervention Name(s)

Tecnis® Aspheric intraocular lens

Intervention Description

Replacement of natural crystalline lens in cataract surgery

Intervention Type

Device

Intervention Name(s)

Akreos® MI60 intraocular lens

Intervention Description

Replacement of natural crystalline lens in cataract surgery

Primary Outcome Measure Information:

Title

Contrast sensitivity

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Visual acuity, contrast acuity, wavefront analysis, corneal spherical aberration, manifest refraction.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subjects, aged 50 and over. Subjects diagnosed with bilateral cataracts requiring cataract extraction and implantation of a posterior chamber intraocular lens. Subjects must be willing to undertake the additional ophthalmic tests within 3 months of the second lens implantation. Subjects must be assessed to be able to dilate to a minimum of 6 mm pre operatively. Subjects' pupil size must be ≥ 4.5 mm in mesopic conditions. Exclusion Criteria: Subjects who have previously had corneal surgery. Subjects who have potential visual acuity which is < 6/12 due to other ocular pathology Subjects with corneal pathology. Subjects with astigmatism of greater than 1D. Subjects diagnosed with glaucoma. Subjects diagnosed with diabetes. Subjects who have previously participated in a clinical investigation within 30 days prior to enrolment Subjects with a know history of poor compliance Subjects with planned adjunctive surgery

Facility Information:

Facility Name

Alcon Call Center

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76134

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL

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