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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Tecnis Z9002 Intraocular Lens (IOL)

Group Type ACTIVE_COMPARATOR

Intraocular Lens (IOL)

Intervention Type DEVICE

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

Softec HD Intraocular Lens (IOL)

Group Type ACTIVE_COMPARATOR

Intraocular Lens (IOL)

Intervention Type DEVICE

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

Interventions

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Intraocular Lens (IOL)

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No