DEXTENZA VS. PREDNISOLONE ACETATE 1% Macular Edema With Diabetic Retinopathy After Cataract Surgery

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The complicated schedules for administering topical steroid eye drops combined with forgetfulness and physical difficulties instilling the drops may compromise compliance; which in turn could increase the risk for secondary complications such as PME post-cataract surgery, especially in a high-risk diabetic population. Dextenza, a sustained- release steroid insert, could help preclude adherence difficulties and provide better bioavailability, being as effective as, or more effective than steroid drops in preventing PME. The aim of this study is to assess the incidence of PME in diabetic patients undergoing cataract surgery when comparing the Dextenza insert to topical prednisolone acetate 1% drops.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ophthalmic Consultants of the Capital Region
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Binocular

• >18 years old

• Any level of Background Diabetic Retinopathy

• Cataract surgery candidate in each eye

• Pre-operative OCT and Fluorescein Angiography showing no Macular edema

Exclusion Criteria:

• Participant cannot complete second eye operation within 60 days of the first cataract surgery

• Maintains regular use of systemic or ocular steroids at time of enrollment

• Maintains regular use of systemic or ocular non-steroidal anti-inflammatory drugs at time of enrollment

• Anterior chamber cells present at time of enrollment

• Recent febrile illness that precludes or delays participation for 90 days

• Pregnancy or lactation

• Known allergy to dexamethasone

• Known allergy to prednisolone

• Preexisting retinal disease including uveitis, nondiabetic retinal disease, choroidal disorders, diabetic macular edema.

• Posterior capsule rupture or other intraoperative complication in first eye operated on

• Amblyopia

• Anti-VEGF injections within 6 months prior to surgery day.

• Intraocular steroid injection within 6 months prior to surgery day.

• Intraocular surgeries within 6 months prior to surgery day.

• Laser photocoagulation within 30 days prior to surgery day.

• Any type of eye inflammation

• Any punctum inflammation or dacryocystitis