Cataract Diabetic, Macula Edema
Conditions
Keywords
Prednisolone, Dextenza
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.
Interventions
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.
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.
Sponsors
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Unable to fully mask to investigator in order to maintain safety (must assess the investigational Dextenza insert and its position in the lower punctum at each office visit).
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optical Coherence Tomography (OCT) | 7 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
| Measure | Time frame | Description |
|---|---|---|
| Macular Edema | 7 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%. |
Outcome results
None listed