Conventional Surgery vs. Verion/VerifEye

Nowadays cataract patient's expectations are closer to those of refractive surgery patients.
Patients want to be spectacle independent. However, fifteen to twenty percent of cataract
surgery patients have from 1.00 to 3.00 diopters (D) of corneal astigmatism which makes
achieving spectacle independence unlikely in this patients unless the astigmatism is treated
at the time of cataract surgery.

Currently available treatments include corneal or limbal incisions, the use of toric
intraocular lenses (IOLs) or LASIK. Limbal relaxing incisions (LRIs) are the most commonly
used manual method Traditionally, LRIs have been made manually (with a surgical knife). With
the introduction of femtosecond laser to assist during cataract surgery, a new alternative
is available for creating corneal incisions. The stability of the LRIs and visual outcomes
using toric IOLs have been shown.

Regardless of the treatment of choice to correct the astigmatism at time of cataract
extraction, a treatment plan has to be calculated preoperatively. This planning include:
keratometry measurements and the use of a calculator to estimate the treatment and
orientation of IOL and placement of the LRIs.

Keratometry can be measured using a variety of devices including manual keratometers (i.e.
Javal-Shiotz), automated keratometers, corneal topography, and optical biometry ( IOL master
and Lenstar).

Once keratometry to be used has been selected, if the treatment of choice are LRIs, a
calculator is used to determine the location and size of the LRI. Many nomograms have been
developed; the choice of nomogram is the surgeon's prefer one, usually based on prior
experience, and their preferred knife. LRIs calculators are available on line. Nomograms
specify the location, length, size, and number of incisions based on the patient's age, the
type of astigmatism, and the amount of astigmatism correction needed.

If a toric IOL has been chosen then planning the appropriate orientation of the toric IOL is
accomplished by using online calculators. The calculator selects the optimal toric power and
location based on the keratometry and the surgically induced astigmatism (SIA) values
entered by the surgeon.

Intraoperatively, marking the eye and placing the incisions or aligning the toric IOL in the
right axis are key steps for the success of astigmatism correction. Marking of the eye can
be done using a variety of instruments using ink and it is routinely done with the patient
in the upright position to avoid cyclorotation. Once patient is on the table in supine
position, axis should be checked once again. Additional suggested methods to mark the eye
include taking pictures preoperatively to identify anatomical landmarks similar to iris
registration in refractive surgery. The use of iris registration during LASIK was introduced
in 2008. Several publications have shown that patients undergoing wavefront-guided LASIK
with iris recognition achieved better visual and refractive outcomes compared to
conventional LASIK.

Recently, Alcon introduced VERION Image Guided System: Digital Surgical Planning and
Positioning Tools. This system encompasses a reference unit that takes a picture of the eye
with the patient in the sitting position creating a high-resolution digital image of the
patient's eye, capturing scleral vessels, limbus and iris features. It measures keratometry
as well as the corneal diameter (limbus) and pupil size. The information captured is then
transferred automatically to the planner where additional information including target
refraction, manifest refraction, axial length, anterior chamber depth, and lens thickness is
entered for IOL power calculation and astigmatism correction planning. Astigmatism
correction options include corneal incisions, toric IOL and a combination of both.
Intraoperatively, The VERION Digital Marker displays patient information and images from the
VERION Reference Unit. Additionally it positions all incision locations and assists with
lens alignment in real time while accounting for the variable impact of cyclorotation and
patient eye movement. In the OR, it displays a reticle that helps to align the IOL to the
axis according the surgical plan. It also helps to position manual LRIs.

Intraoperative wavefront aberrometry has been used in the last couple of years to confirm
spherical and toric power as well as lens position. The Optiwave Refractive Analysis (ORA)
system can refract the eye in phakic, aphakic, and pseudophakic states at any time during
cataract surgery and assists in IOL power selection and recommendations for toric IOL
positioning before and after implantation as well as LRIs confirming the surgery plan
calculated preoperatively. Furthermore, VerifEye, an ORA hardware upgrade, provides
continuous assessment of the patient's eye allowing for more precise measurements;
therefore, more accurate results and improved refractive outcomes and VerifEye +, the latest
upgrade that provides streaming information on the refractive status and correct IOL
positioning through the right ocular of the surgical microscope. This enables the surgeon to
visualize all the information without having to look up at the monitor screen during the
surgical procedure.

This new technology is an alternative to plan and treat astigmatism at the time of cataract
surgery. It could make this treatment easier for less experience surgeons by facilitating
the calculations and making the identification of the correct axis easier by reducing the
need for manual marks.

The main objective of this study is to evaluate spherical and astigmatism outcomes post
routine cataract surgery when the complete VERION Image Guided System packet + ORA System
with VerifEye or VerifEye + are used in the treatment of pre-existing astigmatism using
toric intraocular lens (IOL) or corneal incisions compared to the surgeon's standard of
care.

Inclusion Criteria:

- Subject is undergoing bilateral cataract extraction or refractive lens exchange with
intraocular lens implantation and astigmatism correction.

- Willing and able to provide written informed consent for participation in the study

- Willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria:

- Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative
diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment,
aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization,
medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve
atrophy, macular degeneration (with anticipated best postoperative visual acuity less
than 20/30), advanced glaucomatous damage, etc.

- Uncontrolled diabetes.

- Use of any systemic or topical drug known to interfere with visual performance.

- Contact lens use during the active treatment portion of the trial.

- Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.

- Pseudoexfoliation syndrome or any other condition that has the potential to weaken
the zonules

- Previous refractive surgery.

- Any clinically significant, serious or severe medical or psychiatric condition that
may increase the risk associated with study participation or study device
implantation or may interfere with the interpretation of study results.

- Participation in (or current participation) any investigational drug or device trial
within the previous 30 days prior to the start date of this trial.

- Intraocular conventional surgery within the past three months or intraocular laser
surgery within one month in the operated eye.