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

Phase 4

Terminated

• Conditions: Cataract
• Interventions: Device: Intraocular Lens (IOL)

• 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

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-24
• Study First Submitted QC: 2010-11-24
• Study First Posted: 2010-11-29
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2014-03
• Last Update Submitted: 2018-10-17
• Last Update Posted: 2018-10-18

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

Arm && Interventions

Group	Intervention	Description
Tecnis Z9002 Intraocular Lens (IOL)	Intraocular Lens (IOL)	-
Softec HD Intraocular Lens (IOL)	Intraocular Lens (IOL)	-

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