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

Lenstec

Status and phase

Terminated

Phase 4

Conditions

Cataract

Treatments

Device: Intraocular Lens (IOL)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01249144

LTHD-10-05

Details and patient eligibility

About

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.

Enrollment

75 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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