Dropless vs. Standard Drops Contralateral Eye Study

Key factors for a successful cataract surgery include, among others, preoperative
measurements for accurate intraocular lens (IOL) calculation, surgical technique and
surgeon's experience but also the use of prophylactic topical antibiotics and
anti-inflammatories (steroidal and non-steroidal, NSAID) to decrease the risk of
postoperative infection (i.e. endophthalmitis) and intraocular inflammation (i.e. macular
edema, CME).

Even though, the large body of literature that supports the significance of prophylactic eye
drops prior to surgery, patient compliance is a common problem. Different factors have been
associated with patient's lack of compliance. It could be due to patient's inability to self
administer the drops, lack of understanding of the importance of using the prophylactic
treatment as well as understanding the instructions of how to administer the drops and its
storage, or just forgetfulness or the fact that they don't like to put the drops multiple
times a day for 2-4 weeks, therefore they just avoid doing it.

There is a new option called "Dropless cataract surgery". This modality of treatment involves
the injection of an eye compatible compound at time of cataract surgery.

The purpose of is to assess the efficacy the compound injected during routine cataract
surgery and intraocular (IOL) implantation with and without a topical NSAID compared to
standard prophylactic treatment that includes the topical use of Moxifloxacin, Ilevro, and
Prednisolone acetate 1%.

Inclusion Criteria:

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

- 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.

- Willing and able to administer eye drops and record the times the drops were
instilled.

- Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes
within 6-15 days between surgeries.

- Potential postoperative best-corrected visual acuity of 20/30 or better

Exclusion Criteria:

- Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative
diabetic retinopathy, shallow anterior chamber, macular edema, 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.

- Presence of epiretinal membrane.

- 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.

- History of chronic intraocular inflammation.

- History of retinal detachment.

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

- Previous radial keratotomy.

- Any additional ocular surgical procedures at time of cataract extraction (i.e. iStent)
except corneal incisions for the correction of astigmatism.

- Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).

- Any clinically significant, serious or severe medical or psychiatric condition that
may increase the risk associated with study participation 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.