Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes

NCT ID: NCT04977427

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-31
• Study Completion Date: 2022-03-31

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.

Conditions

Cataract Diabetic; Macula Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Prednisolone Arm

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

Group Type: ACTIVE_COMPARATOR

Prednisolone Acetate 1% Oph Susp

Intervention Type: DRUG

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.

Dextenza Arm

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

Group Type: ACTIVE_COMPARATOR

Dextenza 0.4Mg Ophthalmic Insert

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Jacob Fleenor

Resident Physician, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jacob Fleenor, MD

Role: CONTACT

Jacob.Fleenor@BSWHealth.org

4237547507

Mark Morgan, MD

Role: CONTACT

Mark.Morgan@BSWHealth.org

Other Identifiers

iRIS RB Number 021-167

Identifier Type: -

Identifier Source: org_study_id