Resident-Performed Laser-Assisted vs Manual Traditional Phacoemulsification Cataract Surgery

The study design will be a prospective study comparing laser-assisted cataract extraction
cases and traditional manual phacoemulsification cases. All cases will be performed by
faculty-supervised residents at Parkland Memorial Hospital. Cataract surgery training is a
standard requirement of all ophthalmology residents who are part of this clinical study.

Each resident must be a post graduate year 4 (PGY-4) level resident before being asked to be
a part of this clinical study. Typically, each resident will have completed approximately 30
cataract surgeries by their PGY-3 residency year of training. These traditional
phacoemulsification require manual capsulorrhexis creation with which residents will have
experience prior to study participation. Other critical manual surgical steps of traditional
and femtosecond-laser assisted cataract surgery require similar surgical skill sets, thus
residents should have surgical skills applicable to both techniques prior to study
involvement.

In addition to performing 30 traditional phacoemulsification surgeries, residents also will
have assisted with femtosecond laser-assisted cases during their PGY-3 training year training
at the Dallas VA medical center and with staff at University of Texas (UT) Southwestern
Medical Center during their cornea rotation. The femtosecond-assisted cases completed by each
resident in the study at Parkland will be the Alcon Certification cases for each resident.
Performing femtosecond-laser assisted cases at this level of training will provide objective
insights into this new surgical technique in resident hands. Patients will not be subjected
to any additional risk due to participation in this study as femtosecond laser Alcon
Certification is already being performed by residents as part of their standard UT
Southwestern ophthalmology training.

Patient eyes that meet the inclusion and exclusion criteria below will be randomly assigned
to either the laser-assisted or the standard manual phacoemulsification group based.
Following surgery, patients will return for post-operative visits at post-op day 1, post-op
week 1, post-op month 1, and post-op month 3. Subjects will be followed in the Parkland
Surgery Chief clinic. Subjects will not necessarily see the same study surgeon during each
post-operative visit period. It should be noted this is the standard procedure as currently
practiced in the Parkland ophthalmology clinic.

Verification of subject adherence to the post-operative follow-up visit schedule will be
overseen by the PI throughout the course of the project. Weekly communication with
sub-investigators will take place in order to review any outstanding concerns including
recruitment effort, surgery schedules, and post-operative visit timelines. Arrangements for
additional visits will also be reviewed and scheduled if medically necessary depending on
individual patients' post-operative clinical course. Patients will be assigned to each group
during the period of September 2015 through July 2016 and followed as part of the study for 3
months post-operatively.

Patients will be offered the same kerato-refractive procedures including manual limbal
relaxing incisions or LenSx astigmatic keratotomy that would be offered to patients who are
not part of this study. Patients will also be evaluated for benefit from advanced technology
intraocular lenses (Toric for astigmatism and ReStor multifocal) that patients who are not
part of the study would be offered. Offering advanced technology lenses or combined
kerato-refractive procedures is not expected to influence the visual acuity study outcomes
for patients in this study. Patient's clinical history, past medical history and ophthalmic
medical notes (in particular pre-operative evaluation, operative, and post-operative follow
up) will be reviewed. De-identified data points will be extracted for this project.

Inclusion Criteria:

1. Referred for cataract surgery at Parkland Memorial Hospital

2. Potential post-operative visual acuity of 20/30 or greater determined by potential
acuity meter (PAM) testing

3. Clear intraocular media other than cataract in study eye(s)

4. Subject eyes will have a dilated pupil diameter of at least 6 mm

5. Subject eyes will lack other pre‐existing ocular pathology or condition that may
confound treatment effects, including diabetic retinopathy, previous retinal
detachment, iris neovascularization, amblyopia, optic nerve atrophy or recurrent
severe anterior or posterior segment inflammation of unknown etiology.

Exclusion Criteria:

1. Severe corneal diseases or prior corneal surgery

2. Active, significant external ocular or eyelid disease

3. History of lens abnormalities including posterior polar cataract and zonular weakness
precluding standard non‐complex cataract surgery

4. Retinal or posterior segment disease

5. Advanced glaucoma, white or advanced cataract (precluding adequate examination of the
posterior pole)

6. Anatomic conditions that prevent placement of the femtosecond laser docking ring

7. Corneal opacity that will interfere with the laser beam (hazy cornea)

8. Presence of blood or materials in the anterior chamber

9. Hypotony, advanced glaucoma, or presence of cornea implant

10. Poor dilating pupil such that the iris is not peripheral to the intended diameter for
the capsulotomy

11. Condition which would cause inadequate clearance between the intended capsulotomy
depth and the corneal endothelium

12. Any contraindication to cataract or kerato‐refractive surgery

13. Contact lens wearers must discontinue the use of contacts for an appropriate period of
time to ensure that their corneas are stable before screening measurements are
performed. For rigid gas permeable (RGP) lenses, it is at least 2‐4 weeks before
accurate imaging measurements can be performed. Study doctor will assess patient
findings and determine how long RGP lens wear must be discontinued prior to surgery.
For soft contact lenses, it is at least 3 days prior to study measurements.