Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Toric IOL in an Asian Population
NCT ID: NCT04528069
Last Updated: 2022-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2020-11-16
2021-12-17
Brief Summary
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Detailed Description
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Subjects will attend a total of 10 scheduled visits as follows: 1 screening visit, 1 operative visit for each eye, 2 post-operative visits for each eye, and 3 postoperative visits where both eyes will be evaluated. The duration of participation for each subject will be approximately 8 months.
This study will be conducted in Australia.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PanOptix Toric Trifocal IOL
PanOptix Toric Trifocal IOL implanted in the capsular bag in the posterior chamber following cataract surgery and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation).
ACRYSOF® IQ PanOptix® Toric Trifocal IOL
Single-piece, ultraviolet and blue-light filtering, foldable, multifocal toric IOL intended to provide vision to aphakic subjects at near, intermediate, and distance and to correct pre-existing corneal astigmatism. This device is approved in Australia.
Cataract surgery
Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use
Interventions
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ACRYSOF® IQ PanOptix® Toric Trifocal IOL
Single-piece, ultraviolet and blue-light filtering, foldable, multifocal toric IOL intended to provide vision to aphakic subjects at near, intermediate, and distance and to correct pre-existing corneal astigmatism. This device is approved in Australia.
Cataract surgery
Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Calculated target residual refractive error within ±0.50 diopter (D) of emmetropia within the commercially available IOL Power Range in both operative eyes;
* Preoperative regular corneal keratometric astigmatism with predicted residual refractive astigmatism ≤ 0.50 diopter (D) in both operative eyes;
Exclusion Criteria
* Clinically significant corneal abnormalities;
* Glaucoma;
* History of or current retinal disease; anterior or posterior segment inflammation;
* Other planned ocular surgical procedures including, but not limited to, limbal relaxing incision (LRI)/Astigmatic Keratotomy and laser-assisted in situ keratomileusis (LASIK);
20 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Sr. Clinical Trial Lead, CDMA Surgical
Role: STUDY_DIRECTOR
Alcon Research, LLC
Locations
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Alcon Investigator 8117
Campsie, New South Wales, Australia
Alcon Investigator 7678
Sydney, New South Wales, Australia
Alcon Investigator 7813
Footscray, Victoria, Australia
Alcon Investigator 8122
Saint Albans, Victoria, Australia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ILX140-P001
Identifier Type: -
Identifier Source: org_study_id