N/A
N=68
Clinical Investigation of the AcrySof® IQ PanOptix™ IOL
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT03090256 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Monocular Photopic Best Corrected Distance Visual Acuity (5 m) — 15; 5; 9; 8 subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AcrySof® IQ PanOptix™ IOL (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Monocular Photopic Best Corrected Distance Visual Acuity (5 m) |
15; 5; 9; 8; 35; 34 | — |
| PRIMARY Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) |
47; 40; 18; 18; 1; 8 | — |
| PRIMARY Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) |
48; 40; 20; 27; 1; 0 | — |
Summary
The purpose of this study is to evaluate the effectiveness and safety of the AcrySof® IQ PanOptix™ Intraocular Lens (IOL) Model TFNT00 when implanted to replace the natural lens following cataract removal.
Eligibility Criteria
Inclusion Criteria
- Able to comprehend and sign a statement of informed consent;
- Willing and able to complete all required postoperative visits;
- Cataracts in both eyes with planned cataract removal by phacoemulsification;
- Calculated lens power within the available range;
- Potential postoperative best corrected distance visual acuity (BCDVA) of 0.5 decimal or better in both eyes;
- Able to undergo second eye surgery within 30 days of the first eye surgery.
Exclusion Criteria
- Significant irregular corneal aberration as demonstrated by corneal topography;
- Inflammation or edema (swelling) of the cornea affecting post-operative visual acuity;
- Degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses;
- Previous refractive surgery;
- Diabetic retinopathy
- Other eye conditions as specified in the protocol
- Pregnant.
Data sourced from ClinicalTrials.gov (NCT03090256). 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.