Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes

Overview

This study aims to compare the effectiveness of Dextenza vs standard of care prednisolone taper after cataract surgery in diabetic patients with regards to controlling post-op inflammation at post-op days 7, 14, and 30.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: January 2022

Detailed Description

The inflammation after cataract surgery is controlled at the investigators' institution by a taper of prednisolone acetate 1%, which consists of four drops daily for one week, followed by three drops daily for one week, then two drops daily for one week, then one drop daily for one week. Due to the frequency of drops needed after cataract surgery, compliance with the post-op regimen often wavers. This study aims to evaluate the efficacy of Dextenza, which has been shown to be better than placebo after cataract surgery (1), against prednisolone acetate taper. If shown to be as effective without compromising safety, it could be a very convenient alternative to prednisolone acetate taper. Furthermore, if Dextenza is shown to be as effective as prednisolone taper in diabetic patients, it could be logically generalized that it would be effective in patients without diabetes as well, as patients without diabetes (and with no confounding risk factors, such as a history of uveitis) are less prone to developing post-op macular edema. Risks are minimal for this FDA approved treatment and include iridocyclitis (10%); intraocular pressure increased (6%); visual acuity reduced (2%); cystoid macular edema (1%); corneal edema (1%); eye pain (1%) and conjunctival hyperemia (1%). These risks are comparable to prednisolone acetate.

Interventions

  • Drug: Dextenza 0.4Mg Ophthalmic Insert
    • Dexamethasone inserted into lower punctum at the end of cataract surgery in order to control inflammation in the eye for the following 30 days after surgery.
  • Drug: Prednisolone Acetate 1% Oph Susp
    • Standard Prednisolone taper following cataract surgery, QID for one week, followed by TID for one week, BID for one week, and QDaily for one week, then stop.

Arms, Groups and Cohorts

  • Active Comparator: Prednisolone Arm
    • Standard post-cataract surgery therapy arm; acts as control in each patient.
  • Active Comparator: Dextenza Arm
    • Investigational arm to compare the effectiveness of the Dextenza insert to standard therapy.

Clinical Trial Outcome Measures

Primary Measures

  • Intraocular Inflammation
    • Time Frame: 7 days
    • The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of inflammation in the eye following cataract surgery when compared to prednisolone acetate 1%.
  • Intraocular Inflammation
    • Time Frame: 14 days
    • The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of inflammation in the eye following cataract surgery when compared to prednisolone acetate 1%.
  • Intraocular Inflammation
    • Time Frame: 30 days
    • The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of inflammation in the eye following cataract surgery when compared to prednisolone acetate 1%.

Secondary Measures

  • Macular Edema
    • Time Frame: 7 days
    • The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of macular edema in the eye on OCT imaging following cataract surgery when compared to prednisolone acetate 1%.
  • Macular Edema
    • Time Frame: 14 days
    • The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of macular edema in the eye on OCT imaging following cataract surgery when compared to prednisolone acetate 1%.
  • Macular Edema
    • Time Frame: 30 days
    • The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of macular edema in the eye on OCT imaging following cataract surgery when compared to prednisolone acetate 1%.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with diagnosed diabetes – Patients must be undergoing cataract surgery in each eye – Patients must have no worse than moderate nonproliferative diabetic retinopathy Exclusion Criteria:

  • Patients must not have any history of documented macular edema on OCT – Patients must not have any macular edema on pre-op OCT – Patients must not have any history of uveitis – Patients must not have severe nonproliferative or proliferative diabetic retinopathy – Patients with operative complications will be excluded from this study – Patients with any active corneal disease, infectious or rheumatologic, will be excluded – Patients must not be pregnant

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Baylor Research Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jacob Fleenor, Resident Physician, Principal Investigator – Baylor Research Institute
  • Overall Contact(s)
    • Jacob Fleenor, MD, 4237547507, Jacob.Fleenor@BSWHealth.org

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