Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens

Rationale: Patient expectations of spectacle independence at all distances following cataract
surgery have substantially increased in recent years.Though most of the contemporary
presbyopia-correcting premium intraocular lenses (IOLs) provide adequate functional vision
and patient satisfaction, each has advantages and disadvantages. Multifocal and trifocal IOLs
provide good functional vision, but they are limited by reduced contrast, visual disturbances
and, with discrete non-continuous range of vision. More recently, extended range of vision
IOLs that are designed to improve vision from far to intermediate or near distances have been
introduced to the market.

The design and mechanism of action of the AcuFocus, Inc., IC-8 IOL is based on the
well-established concept of small aperture (small hole) optics. In cameras, depth of focus is
controlled by reducing the aperture through which light enters; the smaller the aperture, the
greater the depth of focus. This concept also applies to the human eye. If an opaque disc
with a small aperture in the center is placed in front of the eye, the peripheral rays will
be obscured while the central rays pass unaffected. Since peripheral rays enter the eye at
larger angle, they create a larger blur circle at the retinal image plane. Eliminating these
peripheral rays reduces the size of the blur-circle, improving image resolution.

The IC-8 IOL (AcuFocus, Inc.) is a small aperture IOL that reduces defocus by decreasing the
size of the blur circle to achieve extended depth of focus. The relation between reducing
pinhole size and improving visual acuity in patients with refractive ametropia has been well
established. This principle is currently being used successfully via the KAMRA inlay
(AcuFocus Inc.), which was FDA-approved for presbyopia correction in April 2015. The small
aperture IOL is thought to provide good uncorrected intermediate and near vision with fewer
visual symptoms and potentially a greater tolerance to residual astigmatism as a result of
its extended depth of focus.

Objective: To determine the safety and effectiveness of the IC-8 IOL implanted in one eye and
a monofocal IOL implanted in the fellow eye, in accordance with the indication.

Study Design: Prospective, multi-center, open-label, parallel-group, non-randomized,
examiner-masked,one-year clinical study. Study Population: 475 patients with bilateral
cataracts who require cataract surgery.

Inclusion Criteria:

1. Minimum 22 years of age;

2. Able to comprehend and have signed a statement of informed consent;

3. Availability, willingness, ability and sufficient cognitive awareness to comply with
examination procedures and study visits;

4. Planned crystalline lens removal by phacoemulsification, with or without femtosecond
laser-assisted extraction, and posterior chamber IOL implantation in both eyes;

5. Cataractous lens changes as demonstrated by best-corrected visual acuity (BCDVA) of
20/40 or worse either with or without a glare source present;

6. Potential for postoperative BCDVA of 20/25 or better in each eye after cataract
removal and IOL implantation as estimated by an instrument such as a Potential Acuity
Meter (PAM) or investigator estimation;

7. Clear intraocular media, other than cataract.

Exclusion Criteria:

1. Requiring an IC-8 intraocular lens outside the available spherical power range of
+15.5 D to +27.5 D;

2. Pharmacologically dilated pupil size less than 6 mm in either eye;

3. Inability to achieve stable keratometric readings for contact lens wearers (difference
in corneal astigmatism between two visits at least 1 week apart following
discontinuation of contact lens wear is within ± 0.50 diopter in magnitude and within
± 15º in axis);

4. Patients with irregular astigmatism in either eye;

5. Preoperative corneal astigmatism > 1.50 diopters in either eye (as assessed by
Biometry keratometric readings);

6. Active or recurrent anterior segment pathology (chronic uveitis, iritis,
iridocyclitis, rubeosis iridis, Reiter's syndrome, etc.);

7. Presence of ocular abnormalities other than cataract such as:

1. Corneal abnormalities other than regular corneal astigmatism up to 1.50 diopter

2. Pupil abnormalities

3. Strabismus or amblyopia

4. Capsular or zonular abnormalities

5. Glaucomatous retinal nerve fiber changes

6. Recurrent and/or persistent intraocular inflammation

7. Known pathology that may affect visual acuity and/or is predicted to cause future
acuity losses to a level worse than 20/25 BCDVA (e.g., macular degeneration)

8. Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate
vision even with dry eye medication;

9. Congenital cataracts;

10. Previous corneal or intraocular surgery, except pterygium surgery, which may be
allowed, based meeting all other inclusion/exclusion criteria;

11. History of ocular trauma or ocular conditions expected to require retinal laser
treatment or other surgical intervention;

12. Use of systemic or ocular medications that may affect vision or likely to impact pupil
dilation or iris structure, such as any prior or current use of tamsulosin or
silodosin (alpha-adrenergic antagonist medications, e.g., Flomax, Flomaxtra, Rapaflo),
which are likely to cause poor dilation or lack of adequate iris structure to perform
standard cataract surgery;

13. Acute, chronic or uncontrolled systemic disease that would, in the opinion of the
investigator, increase the operative risk or confound the outcomes of the study (e.g.,
immune compromised, connective tissue disease, hypertension, Type I & II diabetes
etc.);

14. Use of antipsychotic and/or anti-depressant medication within the last 6 months, or
plan/need to use such medications during the course of the study, which, could
increase the operative risk or confound the outcome(s) of the study in the opinion of
the investigator;

15. Patient is pregnant, plans to become pregnant, is lactating or has another condition
associated with hormonal fluctuation that could lead to refractive changes and dry
eye;

16. Concurrent participation or participation in any clinical trial up to 30 days prior to
preoperative visit.