Efficacy of Dextenza Insert in Upper vs Lower Punctum Following Cataract Surgery With PCIOL.
Condition: Cataract
MeSH terms: Cataract
Intervention: Dextenza 0.4Mg Ophthalmic Insert
Intervention description: (dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Each subject's participation is expected to last for approximately 1 month and will be required to complete six scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 8, Day 14 and Day 30.
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PCIOL; CCI CE

Summary:

      To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone
      (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant
      (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to
      the upper punctum.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects will be eligible for study participation if they:

          1. Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes with or
             without iStent/Hydrus/Goniotomy.

          2. Are willing and able to comply with clinic visits and study related procedures.

          3. Are willing and able to sign the informed consent form.

          4. Not pregnant.

        Exclusion Criteria:

        Subjects are not eligible for study participation if they:

          1. Are currently being treated with corticosteroid implant (i.e. Ozurdex).

          2. Have a history of herpes simplex virus keratitis or present active bacterial, viral,
             or fungal keratitis in either eye.

          3. Have a history of complete punctal occlusion in one or both punctum.

          4. Currently use topical ophthalmic steroid medications.

          5. Are unwilling or unable to comply with the study protocol.

          6. Are determined by the Investigator to not be included for reasons not already
             specified (e.g., systemic, behavioral, or other ocular disease/abnormality) or if the
             health of the subject or the validity of the study outcomes may be compromised by the
             subject's enrollment.

          7. Have active infectious systemic disease.

          8. Have active infectious ocular or extraocular disease.

          9. Have unobstructed nasolacrimal duct in the study eye(s) (dacrocystitis).

         10. Have known hypersensitivity to dexamethasone or are a known steroid responder.

         11. Have a history of ocular inflammation or macular edema.

         12. Are currently being treated with immunomodulating agents in the study eye(s).

         13. Are currently being treated with immunosuppressants an/or oral steroids.

         14. Are Pregnant or breast-feeding or wish to become pregnant during the length of study
             participation.