Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes

Conditions
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Cataract Diabetic, Macula Edema

Intervention / Treatment
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* Drug: Dextenza 0.4Mg Ophthalmic Insert
* Drug: Prednisolone Acetate 1% Oph Susp


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prednisolone Arm<br>Standard post-cataract surgery therapy arm; acts as control in each patient. | Drug: Prednisolone Acetate 1% Oph Susp<br>* 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.<br>|
| Active Comparator: Dextenza Arm<br>Investigational arm to compare the effectiveness of the Dextenza insert to standard therapy. | Drug: Dextenza 0.4Mg Ophthalmic Insert<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Inflammation | 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%. | 7 days | 
| Intraocular Inflammation | 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%. | 14 days | 
| Intraocular Inflammation | 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%. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular Edema | 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%. | 7 days | 
| Macular Edema | 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%. | 14 days | 
| Macular Edema | 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%. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prednisolone, Dextenza