NCT04977427

Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Cataract Diabetic
• Macula Edema

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-08-31
• Primary completion: 2021-12-20
• Completion: 2021-12-20
• First posted: 2021-07-27
• Last updated: 2026-03-02

Regulatory

• FDA-regulated drug study