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Visual and Refractive Outcomes After Implantation of Aspheric IOLs With Different Dioptric Increments and Manufacturing

Primary Purpose

Cataract

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Intraocular Lens (IOL)

About this trial

This is an interventional treatment trial for Cataract focused on measuring Intraocular Lens (IOL), Quarter Diopter, Biaspheric

Eligibility Criteria

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

Inclusion Criteria:

operable cataracts in both eyes
require intraocular lenses (IOLs) in dioptric range from 18.0 diopters to 25.0 diopters in both eyes
</=1 diopter (D) of regular astigmatism in both eyes

Exclusion Criteria:

Intraocular surgery or laser treatment prior to cataract surgery
Severe dry eye
Presence of ocular infection
Uncontrolled intraocular pressure (IOP) or glaucoma preventing a postoperative best corrected visual acuity (BCVA) of 20/25 Snellen or better
Retinal or macular pathology preventing a postoperative BCVA of 20/25 Snellen or better
History of retinal detachment
Corneal decompensation
History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
Clinically significant corneal endothelial dystrophy (e.g., Fuchs' dystrophy)
Amblyopia preventing a postoperative BCVA of 20/25 Snellen or better

Sites / Locations

St. Luke's Cataract & Laser Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Tecnis Z9002 Intraocular Lens (IOL)

Softec HD Intraocular Lens (IOL)

Arm Description

Outcomes

Primary Outcome Measures

Target versus Achieved Refraction

Secondary Outcome Measures

Uncorrected Visual Acuity

Full Information

NCT ID

NCT01249144

First Posted

November 24, 2010

Last Updated

October 17, 2018

Sponsor

Lenstec Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01249144

Brief Title

Visual and Refractive Outcomes After Implantation of Aspheric IOLs With Different Dioptric Increments and Manufacturing

Official Title

A Randomized Fellow-eye Controlled Clinical Trial to Compare the Visual and Refractive Outcomes Between Two Aspheric IOLs With Different Dioptric Increments and Manufacturing Tolerances in Patients Undergoing Bilateral Cataract Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Terminated

Why Stopped

Sponsor stopped study to re-design trial

Study Start Date

October 2010 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lenstec Incorporated

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study compares two intraocular lenses, the Softec HD and the Tecnis Z9002, used to replace the natural crystalline lens after cataract extraction. The variables compared include 1) the accuracy of targeted versus achieved refractive outcomes and 2) visual acuity outcomes three months after implantation.

6. Conditions and Keywords

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

Cataract

Keywords

Intraocular Lens (IOL), Quarter Diopter, Biaspheric

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tecnis Z9002 Intraocular Lens (IOL)

Arm Type

Active Comparator

Arm Title

Softec HD Intraocular Lens (IOL)

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Intraocular Lens (IOL)

Intervention Description

Device for implantation in the capsular bag of the eye for visual correction of aphakia following cataract surgery.

Primary Outcome Measure Information:

Title

Target versus Achieved Refraction

Time Frame

3 Months Postoperative

Secondary Outcome Measure Information:

Title

Uncorrected Visual Acuity

Time Frame

3 Months Postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: operable cataracts in both eyes require intraocular lenses (IOLs) in dioptric range from 18.0 diopters to 25.0 diopters in both eyes </=1 diopter (D) of regular astigmatism in both eyes Exclusion Criteria: Intraocular surgery or laser treatment prior to cataract surgery Severe dry eye Presence of ocular infection Uncontrolled intraocular pressure (IOP) or glaucoma preventing a postoperative best corrected visual acuity (BCVA) of 20/25 Snellen or better Retinal or macular pathology preventing a postoperative BCVA of 20/25 Snellen or better History of retinal detachment Corneal decompensation History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.) Clinically significant corneal endothelial dystrophy (e.g., Fuchs' dystrophy) Amblyopia preventing a postoperative BCVA of 20/25 Snellen or better

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

J. Pitzer Gills, III, MD

Organizational Affiliation

St. Luke's Cataract and Laser Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Luke's Cataract & Laser Institute

City

Tarpon Springs

State/Province

Florida

ZIP/Postal Code

34689

Country

United States

12. IPD Sharing Statement

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Visual and Refractive Outcomes After Implantation of Aspheric IOLs With Different Dioptric Increments and Manufacturing

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