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

Stopped early · Phase 4

Conditions studied: Cataract

In brief

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.

Key facts

Study ID

NCT01249144

Run by

Lenstec Incorporated

People needed

75

Starts

2010-10-01

Expected to finish

2012-01-01

Last updated by the study team

2018-10-18

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St. Luke's Cataract & Laser Institute — Tarpon Springs, Florida, United States

Full record on ClinicalTrials.gov

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