Dropless vs. Standard Drops Contralateral Eye Study
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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%.
    

Intervention name(s): TriMoxiVanc; Moxifloxacin HCl 0.5%; Ilevro; Prednisolone acetate 1%
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Dropless; Vigamox, Moxeza; Nepafenac 0.3%; Pred Forte, Econopred Plus, Omnipred
Intervention MeSH terms: Moxifloxacin; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Nepafenac; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cataract; Surgery; Prophylaxis