N/A
Completed N=54
Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Toric IOL in an Asian Population
Aphakia · Corneal Astigmatism
Source: ClinicalTrials.gov NCT04528069 ↗
Enrolled (actual)
54
Serious AEs
1.4%
Results posted
Dec 2022
Primary outcomePrimary: Mean Monocular Residual Manifest Cylinder for All Operative Eyes for All IOL Models Combined — 0.219; 0.198 diopter
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Monocular Residual Manifest Cylinder for All Operative Eyes for All IOL Models Combined |
0.219; 0.198 | — |
| PRIMARY Percentage of Eyes With IOL Rotation Less Than 10 Degrees |
100; 100 | — |
| PRIMARY Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) |
0.043; 0.022 | — |
| PRIMARY Mean Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) |
0.075; 0.089 | — |
| PRIMARY Mean Binocular Distance Corrected Near Visual Acuity (DCNVA) |
0.161; 0.139 | — |
| PRIMARY Percentage of Eyes With Secondary Surgical Interventions (SSIs), by Category |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Subjects With a Severe Visual Disturbance |
11.8; 17.0; 14.9; 9.8; 6.3; 0.0 | — |
| PRIMARY Percentage of Subjects With a Most Bothersome Visual Disturbance (QUVID) |
9.8; 4.2; 2.1; 7.8; 0.0; 2.1 | — |
| PRIMARY Percentage of Subjects With Ocular Serious Adverse Events Including Serious Adverse Device Effects |
1.9; 0.0; 1.9; 0.0; 0.0; 2.0 | — |
| PRIMARY Percentage of Subjects With Nonocular Serious Adverse Events Including Serious Adverse Device Effects |
1.9; 1.9 | — |
Eligibility Criteria
Key Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04528069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.