Dropless vs. Standard Drops Contralateral Eye Study
Condition: Cataract
MeSH terms: Cataract
Intervention: TriMoxiVanc; Moxifloxacin HCl 0.5%; Ilevro; Prednisolone acetate 1%
Intervention description: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.; Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.; NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.; Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
Intervention MeSH terms: Moxifloxacin; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Nepafenac; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Cataract; Surgery; Prophylaxis

Summary:

      To compare the use of an injectable compound containing an antibiotic and an
      anti-inflammatory at time of cataract surgery to standard of care that is the use 3 different
      topical medications to prevent inflammation and infection after routine cataract surgery.
    

Eligibility criteria:

        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.