N/A
Completed N=149
Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00
Source: ClinicalTrials.gov NCT02529488 ↗Enrolled (actual)
149
Serious AEs
4.0%
Results posted
Apr 2018
Primary outcomePrimary: Mean Binocular Defocus Visual Acuity (VA) — 0.570; 0.569; 0.404; 0.388 logMAR
Summary
The purpose of this study is to investigate visual outcomes and assess safety at 12 months (330-420 days) post bilateral implantation of the AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Binocular Defocus Visual Acuity (VA) |
0.570; 0.569; 0.404; 0.388; 0.209; 0.214 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision;
- Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
- Clear intraocular media other than cataract in both eyes;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema;
- Ocular trauma, corneal transplant, retinal conditions, degenerative eye disorders, or color vision deficiencies;
- Glaucoma (uncontrolled or controlled with medication) or ocular hypertension;
- Pregnant or lactating;
- Expected to require ocular surgical or retinal laser treatment;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02529488). 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.