Status:
TERMINATED
Visual and Refractive Outcomes After Implantation of Aspheric IOLs With Different Dioptric Increments and Manufacturing
Lead Sponsor:
Lenstec Incorporated
Conditions:
Cataract
Eligibility:
All Genders
21+ years
Phase:
PHASE4
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01249144
Start Date
October 1 2010
End Date
January 1 2012
Last Update
October 18 2018
Active Locations (1)
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1
St. Luke's Cataract & Laser Institute
Tarpon Springs, Florida, United States, 34689