N/A
Completed N=243
Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00
Source: ClinicalTrials.gov NCT03280108 ↗Enrolled (actual)
243
Serious AEs
1.5%
Results posted
Oct 2019
Primary outcomePrimary: Mean Photopic Monocular Best Corrected Distance Visual Acuity (4 m) — -0.014; -0.039 logMAR
Summary
The purpose of this clinical study is to compare the visual outcomes of the AcrySof IQ PanOptix Multifocal Intraocular Lens (IOL) Model TFNT00 against that of a monofocal lens, the AcrySof Monofocal IOL Model SN60AT, in order to demonstrate comparable distance vision and superior near and intermediate vision.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Photopic Monocular Best Corrected Distance Visual Acuity (4 m) |
-0.014; -0.039 | — |
| PRIMARY Mean Photopic Monocular Distance Corrected Visual Acuity at Near (40 cm) |
0.105; 0.529 | <0.001 sig |
| PRIMARY Cumulative Rate of Secondary Surgical Interventions (SSI) Related to Optical Properties of the IOL, First Eye |
1; 0 | — |
| PRIMARY Mean Photopic Without Glare Binocular Distance Contrast Sensitivity |
1.752; 1.733; 1.923; 1.940; 1.527; 1.558 | — |
| PRIMARY Mean Photopic With Glare Binocular Distance Contrast Sensitivity |
1.759; 1.753; 1.897; 1.971; 1.566; 1.593 | — |
| PRIMARY Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity |
1.673; 1.679; 1.717; 1.689; 1.715; 1.777 | — |
| PRIMARY Mean Mesopic With Glare Binocular Distance Contrast Sensitivity |
1.658; 1.678; 1.709; 1.692; 1.691; 1.786 | — |
| SECONDARY Mean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 cm) |
0.070; 0.327 | <0.001 sig |
| SECONDARY Proportion of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire |
80.5; 8.2 | — |
| SECONDARY Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) |
20; 2; 16; 1; 4; 2 | — |
| SECONDARY Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID |
6; 1; 3; 1; 2; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with 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.
- Preoperative keratometric astigmatism of less than 1.0 diopter (D) in both operative eyes.
Exclusion Criteria
- Clinically significant corneal abnormalities including corneal dystrophy, irregularity, inflammation or edema
- Previous refractive surgery or refractive surgery procedures (including, but not limited to LASIK, astigmatic keratotomy, and limbal relaxing incisions)
- Glaucoma (uncontrolled or controlled with medication)
- Degenerative eye disorders (e.g. macular degeneration or other retinal disorders)
- Pregnant or lactating
- Expected to require a second surgical intervention or retinal laser treatment.
Data sourced from ClinicalTrials.gov (NCT03280108). 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.