N/A
Completed N=282
A Clinical Study of the ACRYSOF® IQ EDF Intraocular Lens (IOL)
Source: ClinicalTrials.gov NCT03010254 ↗Enrolled (actual)
282
Serious AEs
1.7%
Results posted
Apr 2020
Primary outcomePrimary: Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm) — 0.175; 0.313 logMAR — p=<0.001
Summary
The purpose of the study is to demonstrate the safety and performance of the ACRYSOF® IQ EDF IOL.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm) |
0.175; 0.313 | <0.001 sig |
| PRIMARY Percentage of Subjects With Ocular Adverse Events |
0.6; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters (m) |
-0.007; -0.044 | — |
| SECONDARY Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm |
0.420; 0.510 | <0.001 sig |
| SECONDARY Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve |
1.61; 1.09 | — |
| SECONDARY Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd) |
0.799; 0.978; 0.794; 0.975 | — |
| SECONDARY Percentage of Subjects Who Respond "Never" to Question 1 of the Spectacle Use Questionnaire: "How Often Do You Wear Eyeglasses for Any Purpose?" |
30.2; 10.0 | — |
| SECONDARY Percentage of Subjects Who Respond "Never" to Question 3 of the Spectacle Use Questionnaire: "How Often Do You Wear Eyeglasses for Intermediate Tasks (e.g., Computer)?" |
75.5; 53.8 | — |
Eligibility Criteria
Inclusion Criteria
- Able to understand and sign an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB) approved Informed Consent Form;
- Diagnosed with cataract in both eyes;
- Planned cataract removal by routine small incision surgery;
- Calculated IOL power is within the clinical study supply range (18.0-25.0 diopter (D) in 0.5 D steps);
- Preoperative regular astigmatism of less than 1.0 D.
Exclusion Criteria
- Pregnancy or lactation current or planned during the course of the study;
- History of anterior segment (corneal, anterior chamber, sulcus) or posterior segment (uveal, vitreo-retinal) pathology including retinal vascular occlusive disease, retinal detachment or peripheral retinal laser photocoagulation, age-related macular degeneration (ARMD), glaucoma (uncontrolled or controlled with medication) or ocular hypertension, diabetic retinopathy, retinitis pigmentosa and any optic nerve pathology.
Data sourced from ClinicalTrials.gov (NCT03010254). 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.