Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes

Baylor Scott and White Health (BSWH)

Status and phase: Unknown; Phase 4

Conditions: Macula Edema; Cataract Diabetic

Treatments: Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Prednisolone Acetate 1% Oph Susp

Study type: Interventional

Funder types: Other

Identifiers

NCT04977427

iRIS RB Number 021-167

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Prednisolone Arm

Active Comparator group

Description:

Standard post-cataract surgery therapy arm; acts as control in each patient.

Treatment:

Drug: Prednisolone Acetate 1% Oph Susp

Dextenza Arm

Active Comparator group

Description:

Investigational arm to compare the effectiveness of the Dextenza insert to standard therapy.

Treatment:

Drug: Dextenza 0.4Mg Ophthalmic Insert