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A Comparison of Corneal Aberrations in Subjects With Contralateral AcrySof IQ Toric Intraocular Lens (IOL) and AcrySof IQ IOL With Limbal Relaxing Incision (LRI)

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Alcon

Status

Completed

Conditions

Cataract
Astigmatism

Treatments

Procedure: Limbal Relaxing Incision (LRI)
Device: AcrySof IQ Aspheric IOL
Device: AcrySof IQ Toric IOL

Study type

Interventional

Funder types

Industry

Identifiers

NCT01045733
M-09-045

Details and patient eligibility

About

The purpose of this study was to evaluate and compare postoperative corneal aberrations and visual parameters in patients contralaterally implanted with an AcrySof IQ Toric intraocular lens (IOL) and AcrySof IQ Aspheric IOL with concomitant limbal relaxing incision.

Enrollment

70 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Ocular criteria must be met in both eyes.

  • Willing and able to understand and sign an informed consent;
  • Willing and able to attend postoperative examinations per protocol schedule;
  • Have cataracts that require extraction followed by implantation of a posterior chamber intraocular lens and used as an on-label procedure;
  • Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and AcrySof IQ Toric package inserts;
  • Have regular, bowtie shaped corneal astigmatism and qualify for an SN6AT3, SN6AT4 or SN6AT5 Intraocular Lens (IOL) in both eyes;
  • Have the second surgery at least one week following the first eye implant but not later than one month after the first implant.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Previous corneal surgery;
  • Planned multiple procedures during cataract/IOL implantation surgery;
  • Ocular disease and/or condition that may compromise study results;
  • Pregnant or planning pregnancy during course of study;
  • Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

70 participants in 2 patient groups

IQ Toric IOL
Experimental group
Description:
AcrySof IQ Toric intraocular lens (IOL) randomly assigned to one eye, with AcrySof IQ Aspheric IOL with Limbal Relaxing Incision (LRI) procedure in the fellow eye for contralateral implantation.
Treatment:
Device: AcrySof IQ Toric IOL
IQ Aspheric IOL + LRI
Active Comparator group
Description:
AcrySof IQ Aspheric intraocular lens (IOL) with Limbal Relaxing Incision (LRI) procedure randomly assigned to one eye, with AcrySof IQ Toric IOL in the fellow eye for contralateral implantation
Treatment:
Device: AcrySof IQ Aspheric IOL
Procedure: Limbal Relaxing Incision (LRI)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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