Trial record 8 of 28 for:    Open Studies | "Astigmatism"

Post Approval Study of the AcrySof® IQ Toric Intraocular Lens (IOL) Models SN6AT6-SN6AT9

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Alcon Research
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01601665
First received: May 16, 2012
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate the use of toric high cylinder power intraocular lenses in a larger population in clinical practice and assure the continued safety of these approved devices.


Condition Intervention
Cataracts
Astigmatism
Device: SN6AT6 Intraocular Lens
Device: SN6AT7 Intraocular Lens
Device: SN6AT8 Intraocular Lens
Device: SN6AT9 Intraocular Lens
Device: SN60WF Intraocular Lens

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Approval Study of the AcrySof® IQ Toric High Cylinder Power IOL Models SN6AT6-SN6AT9

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Rate of Severe Visual Distortions [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    As assessed by a Patient Reported Outcomes (PRO) questionnaire. Subjects will be categorized as experiencing a severe visual distortion if they indicate "severe" as a response to any of the three visual distortion-related questions on the questionnaire.


Estimated Enrollment: 415
Study Start Date: February 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Toric High Cylinder Power IOL
Toric high cylinder power intraocular lens implanted during cataract surgery in the first operative eye, with the second operative eye implanted within 30 days of the first implantation.
Device: SN6AT6 Intraocular Lens
Acrylic intraocular lens with cylinder power at the IOL plane of 3.75 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.
Other Name: AcrySof® IQ Toric Model SN6AT6
Device: SN6AT7 Intraocular Lens
Acrylic intraocular lens with cylinder power at the IOL plane of 4.50 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.
Other Name: AcrySof® IQ Toric Model SN6AT7
Device: SN6AT8 Intraocular Lens
Acrylic intraocular lens with cylinder power at the IOL plane of 5.25 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.
Other Name: AcrySof® IQ Toric Model SN6AT8
Device: SN6AT9 Intraocular Lens
Acrylic intraocular lens with cylinder power at the IOL plane of 6.00 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.
Other Name: AcrySof® IQ Toric Model SN6AT9
Monofocal IOL
Monofocal intraocular lens implanted during cataract surgery in the first operative eye, with the second operative eye implanted within 30 days of the first implantation.
Device: SN60WF Intraocular Lens
Acrylic aspheric monofocal intraocular lens. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.
Other Name: AcrySof® IQ Aspheric NATURAL Model SN60WF

Detailed Description:

In this prospective, non-randomized, unmasked study, subjects with pre-existing corneal astigmatism ≥2.57 diopters will choose to be implanted with either the AcrySof® IQ Toric High Cylinder Power IOL or the AcrySof® IQ Aspheric NATURAL monofocal IOL.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Population will be selected from up to 80 clinical investigative sites.

Criteria

Inclusion Criteria:

  • Diagnosed with bilateral cataracts and in the targeted astigmatism range.
  • Planned cataract removal by phacoemulsification.
  • Pupil size greater than or equal to 6 mm after dilation.
  • Able to undergo second eye surgery within 30 days of first eye surgery.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Irregular corneal astigmatism.
  • Any inflammation or swelling of the cornea.
  • Any corneal abnormality other than regular corneal astigmatism.
  • Previous corneal refractive surgery.
  • Amblyopia.
  • Diabetic retinopathy.
  • Uncontrolled glaucoma.
  • Currently participating in another investigational drug or device study that may confound the results of this investigation.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601665

Contacts
Contact: Alcon Call Center 1-888-451-3937 alcon.medinfo@alcon.com

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations Recruiting
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Martha Giangiordano, BSN Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01601665     History of Changes
Other Study ID Numbers: C-11-020
Study First Received: May 16, 2012
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
Intraocular lens
Cataracts
Astigmatism
Toric

Additional relevant MeSH terms:
Astigmatism
Cataract
Refractive Errors
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on August 25, 2014