Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes

Last updated: July 15, 2021
Sponsor: Baylor Research Institute
Overall Status: Active - Not Recruiting

Phase

4

Condition

Vision Loss

Eye Disorders/infections

Eye Disease

Treatment

N/A

Clinical Study ID

NCT04977427
iRIS RB Number 021-167
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 beexcluded
  • Patients must not be pregnant

Study Design

Total Participants: 200
Study Start date:
July 01, 2021
Estimated Completion Date:
March 31, 2022

Study 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.