Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Toric IOL in an Asian Population
Study Details
Study Description
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 population.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Subjects will attend 10 scheduled visits as follows: 1 screening visit, 1 operative visit and 2 post-operative visits for each eye, and 3 postoperative visits where both eyes will be evaluated.
This study will be conducted in Australia.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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). |
Device: 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.
Other Names:
Procedure: Cataract surgery
Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use
|
Outcome Measures
Primary Outcome Measures
- Mean monocular residual manifest cylinder [Up to Month 6]
Mean monocular residual manifest cylinder will be calculated for all IOL models combined
- Percentage of IOLs with less than 10 degree rotation [Day 1 postoperative, up to Month 6]
Rotation is defined as the difference in IOL axis of orientation from Day 1 postoperative
- Mean binocular Best Corrected Distance Visual Acuity (BCDVA) [Up to Month 6]
Visual acuity will be assessed at a distance of 4 meters under well-lit conditions with spectacles or other visual corrective devices in place. Eyes will be assessed together.
- Mean binocular Distance Corrected Intermediate Visual Acuity (DCIVA) [Up to Month 6]
Visual acuity will be assessed at a distance of 60 centimeters under well-lit conditions with spectacles or other visual corrective devices in place. Eyes will be assessed together.
- Mean binocular Distance Corrected Near Visual Acuity (DCNVA) [Up to Month 6]
Visual acuity will be assessed at a distance of 40 centimeters under well-lit conditions with spectacles or other visual corrective devices in place. Eyes will be assessed together.
- Rate of Secondary Surgical Interventions (SSIs), by category [Up to Month 6]
A secondary surgical intervention (SSI) is defined as a surgical procedure occurring after primary implantation of the IOL. The rate of SSIs will be reported categorically, as the rate of SSIs related to optical properties of the IOL, and the rate of all SSIs.
- Rate of visual disturbances, by category [Up to Month 6]
Visual disturbances will be assessed by the subject using the Questionnaire for Visual Disturbances (QUVID) and reported categorically as "severe" and "most bothersome." This outcome measure is pre-specified for subjects with binocular implantation (both eyes).
- Rate of adverse events [Up to Month 6]
An adverse event (AE) is defined as untoward medical occurrence, unintended disease or injury, or untoward clinical sign (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product).
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
Planned bilateral cataract removal followed by posterior chamber IOL implantation with PanOptix Toric (TFNT30, TFNT40, TFNT50, or TFNT60);
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Calculated target residual refractive error within ±0.50 diopter (D) of emmetropia within the commercially available IOL Power Range in both operative eyes;
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Preoperative regular corneal keratometric astigmatism with predicted residual refractive astigmatism ≤ 0.50 diopter (D) in both operative eyes;
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Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
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Preoperative irregular astigmatism;
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Clinically significant corneal abnormalities;
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Glaucoma;
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History of or current retinal disease; anterior or posterior segment inflammation;
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Other planned ocular surgical procedures including, but not limited to, limbal relaxing incision (LRI);
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Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alcon Investigative Site | Campsie | New South Wales | Australia | 2194 |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Sr. Clinical Trial Lead, CDMA Surgical, Alcon Research, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ILX140-P001