Clinical Investigation of the Dextenza 0.4mg Intracanalicular Insert Delivery System Used in Cataract Surgery

• Status: Not yet recruiting
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To monitor intraocular pressure in glaucoma patients after cataract surgery preformed in conjunction with minimally invasive glaucoma surgery (MIGS)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cathleen McCabe MD
• Collaborator: Ocular Therapeutix, Inc.
• Treatments: Dexamethasone; Difluprednate

Criteria

Inclusion Criteria:

• Age 18 or Older

• Mild-to-moderate primary open angle glaucoma and visually significant cataract with plans to undergo clear cornea cataract surgery with Phacoemulsification and implantation of posterior chamber IOL combined with minimally invasive glaucoma surgery ( MIGS) procedure in both eyes.

Exclusion Criteria:

• Use of Topical steroid, systemic steroid or intravitreal steroid implants within last 3 months

• Previous Corneal surgery or pathology

• Active or history of chronic or recurrent inflammatory eye disease in either eye

• Ocular Pain in either eye

• Proliferative diabetic retinopathy in either eye

• Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye.

• Laser or incisional ocular surgery during the study period and 6 months prior in either eye

• Systemic concomitant pain medication management with the pharmacology class of Oxycodone

• Systemic NSAIDS use >/=750 mg daily

• Clinically significant macular edema

• History of cystoid macular edema in either eye