| Eligibility |
Inclusion Criteria:
Note: All criteria apply to each eye
- Minimum 22 years of age
- Bilateral cataracts for which phacoemulsification extraction and posterior IOL
implantation have been planned for both eyes
- Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen (0.5
Decimal) or worse with or without a glare source
- Potential for postoperative BCDVA of 20/30 Snellen (0.66 Decimal) or better
- Corneal astigmatism:
- Normal corneal topography and no irregular corneal astigmatism
- Preoperative corneal astigmatism of 2.50 D or less in both eyes, including
posterior corneal astigmatism (PCA) and surgically induced astigmatism (SIA)
- Clear intraocular media, other than cataract
- Availability, willingness and sufficient cognitive awareness to comply with
examination procedures
- Signed informed consent and HIPAA authorization or equivalent documentation necessary
to comply with applicable privacy laws pertaining to medical treatment in the
governing countries
- Ability to understand and respond to a questionnaire in English or the local language
in which the informed consent and questionnaires are provided
Exclusion Criteria:
- Note: All criteria apply to each eye
- Requiring an intraocular lens power outside the available range of +17.0 D to
+26.0 D
- Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
- Recent ocular trauma or ocular surgery that is not resolved/stable or may affect
visual outcomes or increase risk to the subject
- Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery
- Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that
are predicted to cause visual acuity losses to a level of 20/30 Snellen (0.66
Decimal) or worse during the study
- Inability to achieve keratometric stability for contact lens wearers (see Section
9.3)
- Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration
or other retinal disorders) that are predicted to cause visual acuity losses to a
level of 20/30 Snellen or worse during the study
- Subjects with conditions associated with increased risk of zonular rupture,
including capsular or zonular abnormalities that may lead to IOL decentration or
tilt, such as pseudoexfoliation, trauma, or posterior capsule defects
- Use of systemic or ocular medications that may affect vision Prior, current, or
anticipated use during the course of the 6-month study of tamsulosin or silodosin
(e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator,
confound the outcome or increase the risk to the subject (e.g., poor dilation or
a lack of adequate iris structure to perform standard cataract surgery)
- Inability to focus or fixate for prolonged periods of time (e.g., due to
strabismus, nystagmus, etc.)
- Poorly-controlled diabetes
- Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in
the opinion of the investigator, would increase the operative risk or confound
the outcome(s) of the study (e.g., immunocompromised, connective tissue disease,
suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular
inflammation, etc.). Note: controlled ocular hypertension without glaucomatous
changes is acceptable.
- Known ocular disease or pathology that may affect visual acuity or that may be
expected to require retinal laser treatment or other surgical intervention during
the course of the study (macular degeneration, cystoid macular edema, diabetic
retinopathy, etc.)
- Patient is pregnant, plans to become pregnant, is lactating or has another
condition associated with the fluctuation of hormones that could lead to
refractive changes
- Concurrent participation or participation within 30 days prior to preoperative
visit in any other clinical trial
- Desire for monovision correction
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