Post Approval Study of the AcrySof® IQ Toric Intraocular Lens (IOL) Models SN6AT6-SN6AT9
1 other identifier
observational
477
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 16, 2012
CompletedFirst Posted
Study publicly available on registry
May 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedAugust 4, 2015
July 1, 2015
3.4 years
May 16, 2012
August 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Severe Visual Distortions
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.
6 months
Study Arms (2)
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.
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.
Interventions
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.
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.
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.
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.
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.
Eligibility Criteria
Population will be selected from up to 80 clinical investigative sites.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134, United States
Related Publications (1)
Holladay JT, Wilcox RR, Koch DD, Wang L. Astigmatism analysis and reporting of surgically induced astigmatism and prediction error. J Cataract Refract Surg. 2022 Jul 1;48(7):799-812. doi: 10.1097/j.jcrs.0000000000000871.
PMID: 35749069DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gina Calderon, CM, Surgical
Alcon Research
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2012
First Posted
May 18, 2012
Study Start
February 1, 2012
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
August 4, 2015
Record last verified: 2015-07