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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01249144

Enrollment

Registered

2010-11-29

Start date

2010-10-31

Completion date

2012-01-31

Last updated

2018-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Intraocular Lens (IOL), Quarter Diopter, Biaspheric

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.

Interventions

DEVICEIntraocular Lens (IOL)

Device for implantation in the capsular bag of the eye for visual correction of aphakia following cataract surgery.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Target versus Achieved Refraction	3 Months Postoperative

Secondary

Measure	Time frame
Uncorrected Visual Acuity	3 Months Postoperative

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026