Clinical trial NCT04977427: Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes
Official title: Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cataract Diabetic
Macula Edema
Keywords: Prednisolone
Dextenza
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Fellow-Eye study design, in which one randomized eye in each patient undergoing bilateral cataract surgery receives standard prednisolone therapy, the other eye receiving the investigational Dextenza treatment.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intraocular Inflammation
timeFrame: 7 days
measure: Intraocular Inflammation
timeFrame: 14 days
measure: Intraocular Inflammation
timeFrame: 30 days
Secondary outcomes:
measure: Macular Edema
timeFrame: 7 days
measure: Macular Edema
timeFrame: 14 days
measure: Macular Edema
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References: