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



Status:Terminated
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:21 - Any
Updated:10/20/2018
Start Date:October 2010
End Date:January 2012

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.


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

-
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
We found this trial at
1
site
St. Luke's Cataract & Laser Institute
Tarpon Springs, Florida 34689
?
mi
from
Tarpon Springs, FL
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