Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes

Sponsor

Baylor Research Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04977427

Collaborator

(none)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Diabetic Macula Edema	Drug: Dextenza 0.4Mg Ophthalmic Insert Drug: Prednisolone Acetate 1% Oph Susp	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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 (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).

Primary Purpose:

Treatment

Official Title:

Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes

Anticipated Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Prednisolone Arm

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

Drug: Prednisolone Acetate 1% Oph Susp

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.

Active Comparator: Dextenza Arm

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

Drug: Dextenza 0.4Mg Ophthalmic Insert

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.

Outcome Measures

Primary Outcome Measures

Intraocular Inflammation [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%.
Intraocular Inflammation [14 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%.
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

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%.
Macular Edema [14 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%.
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%.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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