A Comparative Pilot Study Of High-Order Aberrations With Aspheric IOL Models SN60WF and ZCB00

Alcon

Status: Completed

Conditions: Cataracts

Treatments: Device: Tecnis 1-piece Aspheric Acrylic (ZCB00) IOL; Device: AcrySof Natural IQ (SN60WF) IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT01105585

M-09-003

Details and patient eligibility

About

The purpose of this study was to prospectively compare high-order aberrations between eyes implanted with the AcrySof® Natural IQ (SN60WF) intraocular lens (IOL) versus those implanted with the Tecnis ZCB00 IOL.

Enrollment: 20 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Requires bilateral extraction of cataracts by phacoemulsification followed by implantation of a posterior chamber intraocular lens;
• Confirmed absence of pre-existing conditions that could skew the results or present contraindications for the IQ intraocular lens (IOL) or the Tecnis ZCB00 IOL;
• <1 diopter corneal astigmatism preoperatively;
• Able to achieve 6.5 mm dilated pupil;
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Chronic disease or illness;
• Irregular optical aberration;
• Amblyopia;
• History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);
• Diabetic retinopathy;
• Macular degeneration;
• History of retinal detachment;
• Other surgeries planned at time of cataract removal;
• Severe dry eye;
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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20 participants in 2 patient groups

ZCB00 IOL

Experimental group

Description:

Tecnis 1-piece Aspheric Acrylic (ZCB00) intraocular lens (IOL) randomly assigned to one eye, with AcrySof Natural IQ (SN60WF) IOL in the fellow eye for contralateral implantation

Treatment:

Device: Tecnis 1-piece Aspheric Acrylic (ZCB00) IOL

SN60WF IOL

Active Comparator group

Description:

AcrySof Natural IQ (SN60WF) intraocular lens (IOL) randomly assigned to one eye, with Tecnis 1-piece Aspheric Acrylic (ZCB00) intraocular lens in the fellow eye for contralateral implantation

Treatment:

Device: AcrySof Natural IQ (SN60WF) IOL