Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes

Phase 4

• Conditions: Cataract Diabetic; Macula Edema
• Interventions: Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Prednisolone Acetate 1% Oph Susp

• Registration Number: NCT04977427
• Lead Sponsor: Baylor Research Institute

Brief 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.

Study Timeline

• Study First Submitted: 2021-06-29
• Status Verified: 2021-07
• Study Start: 2021-07
• Study First Submitted QC: 2021-07-15
• Last Update Submitted: 2021-07-15
• Study First Posted: 2021-07-27
• Last Update Posted: 2021-07-27
• Primary Completion: 2022-01
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dextenza Arm	Dextenza 0.4Mg Ophthalmic Insert	Investigational arm to compare the effectiveness of the Dextenza insert to standard therapy.
Prednisolone Arm	Prednisolone Acetate 1% Oph Susp	Standard post-cataract surgery therapy arm; acts as control in each patient.

Primary Outcome Measures

Name	Time	Method
Intraocular Inflammation	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 Outcome Measures

Name	Time	Method
Macular Edema	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%.