Status:
COMPLETED
Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Toric IOL in an Asian Population
Lead Sponsor:
Alcon Research
Conditions:
Aphakia
Corneal Astigmatism
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the clinical performance of the ACRYSOF® IQ PanOptix® Toric Trifocal intraocular lens (IOL) when implanted in the eye following cataract removal in an Asian po...
Detailed Description
Both eyes will be implanted with the PanOptix Toric Trifocal IOL. The eye with the highest astigmatism will be implanted first. The second eye will be implanted within 7-14 days of the first eye. Sub...
Eligibility Criteria
Inclusion
- Key
- Planned bilateral cataract removal followed by posterior chamber IOL implantation with PanOptix Toric (TFNT30, TFNT40, TFNT50, or TFNT60);
- 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;
- Other protocol-defined inclusion criteria may apply.
- Key
Exclusion
- Preoperative irregular astigmatism;
- 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);
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
November 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2021
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04528069
Start Date
November 16 2020
End Date
December 17 2021
Last Update
December 30 2022
Active Locations (4)
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1
Alcon Investigator 8117
Campsie, New South Wales, Australia, 2194
2
Alcon Investigator 7678
Sydney, New South Wales, Australia, 2150
3
Alcon Investigator 7813
Footscray, Victoria, Australia, 3011
4
Alcon Investigator 8122
Saint Albans, Victoria, Australia, 3021