Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery
Condition: Glaucoma; Cataract
MeSH terms: Glaucoma; Cataract
Intervention: Dexamethasone Ophthalmic Insert; Prednisolone Acetate 1% Oph Susp
Intervention description: DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.; Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.
Intervention MeSH terms: Dexamethasone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This prospective study enrolled 29 eyes from 25 total patients. The protocol permitted some binocular enrollment from patients who met eligibility criteria in both eyes.
All eligible eyes received concomitant cataract and MIGS surgery. Each eye was randomized to receive either DEXTENZA® insertion at the end of the surgery or to a standard of care prednisolone acetate 1% eye drop regimen via block randomization. All eyes received the standard of care topical ofloxacin antibiotic regimen. The experimental group consisted of the eyes receiving DEXTENZA® insertion. The control group consisted of the eyes placed on the prednisolone eye drop regimen.
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: MIGS, Minimally invasive glaucoma surgery

Summary:

      In this study, the investigators are comparing dexamethasone ophthalmic insert (DEXTENZA®) to
      the current standard of care, prednisolone acetate 1% eye drops, in a glaucoma population
      receiving both cataract and minimally-invasive glaucoma surgery (MIGS). DEXTENZA® and
      prednisolone acetate 1% drops are both steroids used to control inflammation after eye
      surgery. DEXTENZA®'s method of delivery differs by offering a sustained release of steroid
      that does not necessitate postoperative anti-inflammatory eye drops. The investigators
      hypothesize that DEXTENZA® will be as safe as prednisolone acetate 1% drops and as effective
      at controlling postoperative inflammation following concomitant cataract-MIGS in a glaucoma
      population. The investigators also hypothesize that DEXTENZA® will be preferred by patients
      over prednisolone acetate 1% drops.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cataract surgery candidate and glaucoma present in at least one eye.

          -  Minimally-invasive glaucoma surgery candidate in that same eye. Defined by having
             ocular hypertension requiring a medication, OR as by having mild, moderate, or severe
             glaucoma that is sufficiently stable and appropriate for operation.

        Exclusion Criteria:

          -  Maintains regular use (daily or more) of systemic or ocular steroids at time of
             enrollment

          -  Maintains regular use (daily or more) of systemic or ocular nonsteroidal
             anti-inflammatory drugs at time of enrollment

          -  Anterior chamber cells present at time of enrollment

          -  Recent febrile illness that precludes or delays participation for 3 months

          -  Pregnancy or lactation

          -  Known allergy to dexamethasone

          -  Known allergy to prednisolone

          -  Treatment with another investigational drug within the last 20 years

          -  Current recreational drug use

          -  Preexisting ocular pathology likely to confound the visual acuity or comfort endpoints
             including but not limited to: severe corneal scarring, ocular surface disease,
             diabetic retinopathy, or macular edema

          -  Corneal or retinal procedures (laser or incisional) during the study period and 6
             months prior