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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01249144
• Other study ID #: LTHD-10-05
• Status: Terminated
• Phase: Phase 4
• Start date: October 2010
• Est. completion date: January 2012

Study information

• Verified date: March 2014
• Source: Lenstec Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Intraocular Lens (IOL)
Device for implantation in the capsular bag of the eye for visual correction of aphakia following cataract surgery.

Locations

Country	Name	City	State
United States	St. Luke's Cataract & Laser Institute	Tarpon Springs	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Lenstec Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target versus Achieved Refraction		3 Months Postoperative
Secondary	Uncorrected Visual Acuity		3 Months Postoperative