Visual and Refractive Outcomes After Implantation of Aspheric IOLs With Different Dioptric Increments and Manufacturing
Phase 4
Terminated
- Conditions
- Cataract
- Registration Number
- NCT01249144
- Lead Sponsor
- Lenstec Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 75
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Target versus Achieved Refraction 3 Months Postoperative
- Secondary Outcome Measures
Name Time Method Uncorrected Visual Acuity 3 Months Postoperative
Trial Locations
- Locations (1)
St. Luke's Cataract & Laser Institute
🇺🇸Tarpon Springs, Florida, United States
St. Luke's Cataract & Laser Institute🇺🇸Tarpon Springs, Florida, United States