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

Stopped early · Phase 4

Conditions studied: Cataract

In brief

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

Key facts

Study ID

NCT04687800

Run by

Cathleen McCabe MD

People needed

1

Starts

2020-12-01

Expected to finish

2022-10-24

Last updated by the study team

2022-11-10

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The Eye Associates of Manatee — Bradenton, Florida, United States

Full record on ClinicalTrials.gov

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