Dropless™ vs. Less Drops™ Pharmaceutical Regimens After Cataract Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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Modern cataract surgery has become a relatively short out-patient procedure with small incisions and short post-operative recovery time. Surgery can be influenced by surgical technique and experience. Prophylactic pharmaceutical regimens are designed to control post-operative pain and to reduce the potential for inflammation (i.e. macular edema, CME) and infection (i.e. endophthalmitis). The most serious potential infection related to cataract surgery is endophthalmitis. Endophthalmitis is a result of microorganisms entering the eye, either during the surgical procedure or before surgical incisions have healed completely. The risk of infection can be reduced in several ways. Pre-operatively, reducing the bacteria on the cornea and ocular adnexa can be helpful. During surgery, appropriate technique can reduce the potential for ingress. Post-operatively, prophylactic antibiotics can eliminate organisms once they have entered the eye. Topical drops, intracameral antibiotics and subconjunctival injections are typical options in current use, usually selected on the basis of spectrum of coverage, cost, efficacy and/or expected side effects. With regard to inflammation, one of the most common post-operative responses is cystoid macular edema (CME). Steroids and non-steroidal anti-inflammatory drugs (NSAIDs) appear effective in reducing the incidence of CME, with NSAIDs posing a lower risk for IOP spikes and showing greater efficacy some studies. While there is documented evidence of the utility of prophylactic post-operative treatment for pain and infection, patient compliance remains a significant concern. The regimen is often complex, with multiple drops several times per day. Inability to instill the drops, forgetfulness and a lack of appreciation for the importance of compliance can all be contributing factors. There are several new options to try to address the potential issues related to poor patient compliance. One is referred to as dropless cataract surgery, which involves injection of a multi-drug compound into the eye at time of cataract surgery; one such compound includes triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin (TriMoxiVanc). Another alternative is to reduce the burden of the pharmaceutical regimen using a compounded topical medication; this is termed less drops cataract surgery. An option in this regard is a topical formulation of prednisolone acetate, moxifloxacin hydrochloride and ketorolac tromethamine (PredMoxiKetorolac), given for one week post-operatively followed by a topical formulation of prednisolone acetate and ketorolac tromethamine (PredKeterolac) given for weeks 2 to 4 after surgery. The purpose of this study is to evaluate the differences in performance between the dropless and less-drops pharmaceutical regimens after cataract surgery.

Official Title
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Dropless™ vs. Less Drops™ Pharmaceutical Regimens After Cataract Surgery

Conditions
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Intraocular Lens Associated Postoperative Inflammation

Intervention / Treatment
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* Drug: Imprimis Dropless
* Drug: Imprimis Less Drops


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Imprimis Dropless<br>TriMoxiVanc 0.2cc intravitreal one time | Drug: Imprimis Dropless<br>* Tri-Moxi-Vanc transzonular intravitreal injection<br>|
| Active Comparator: Imprimis Less Drops<br>Pred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks. | Drug: Imprimis Less Drops<br>* Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change in Intraocular Pressure (IOP) From Baseline | Based on Goldmann tonometry | To end of study (1 month postop) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Corneal Thickness | Based on corneal pachymetry | To end of study (1 month postop) | 
| Slit Lamp (Cornea Exam) |  | To end of study (1 month postop) |