Dropless™ vs. Less Drops™ Pharmaceutical Regimens After Cataract Surgery
Condition: Intraocular Lens Associated Postoperative Inflammation
MeSH terms: Cataract; Capsule Opacification; Inflammation
Intervention: Imprimis Dropless; Imprimis Less Drops
Intervention description: Tri-Moxi-Vanc transzonular intravitreal injection; Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To compare the relative effectiveness of the Imprimis Dropless™ (TriMoxiVanc) intraocular
      solution with the Less Drops™ topical formulation of PredMoxiKeterolac (given for the first
      week post op) followed by PredKeterolac (given for weeks 2 to 4 after surgery).

      The hypothesis is that the "dropless" regimen will be non-inferior to the "less drops"
      regimen in terms of post-operative IOP changes, post-operative healing, and visual quality.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ocular criteria must be met in both eyes.

          -  Subject is undergoing bilateral cataract extraction or refractive lens exchange with
             intraocular lens implantation.

          -  Gender: Males and Females.

          -  Age: 21 or older.

          -  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 or refractive lens exchange with
             topical anesthesia in both eyes within 6-15 days of each other.

          -  Potential postoperative best-corrected visual acuity of 20/30 or better.

        Exclusion Criteria:

          -  If any of the following exclusion criteria are applicable to the subject or either
             eye, the subject should not be enrolled in the study.

          -  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 refractive surgery.

          -  Anesthesia other than topical, oral or intravenous 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.

        The principal investigator reserves the right to declare a patient ineligible or
        non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

        Exclusion Criteria during surgery:

        If any of the following exclusion criteria are applicable to the study eye, the subject
        should not continue in the study.

          -  If full dose (0.2 cc) is not delivered into the vitreous through the zonules as
             evaluated by surgeon's direct visualization of the material in the posterior chamber
             with lack of material in the anterior chamber and an empty syringe.

          -  Significant vitreous loss.

          -  Significant anterior chamber hyphema.

          -  Uncontrollable intraocular pressure.

          -  Zonular or capsular rupture.

          -  Bag-sulcus, sulcus-sulcus or unknown placement of the haptics.

          -  Suturing of incision required at time of surgery.

          -  Intraocular lens tilt or decentration

          -  Peri-bulbar or retro-bulbar block required during surgery.

          -  Other procedure, such as pupil stretch, expanders, iris hooks during surgery.