Status:
TERMINATED
Clinical Investigation of the Dextenza 0.4mg Intracanalicular Insert Delivery System Used in Cataract Surgery
Lead Sponsor:
Cathleen McCabe MD
Collaborating Sponsors:
Ocular Therapeutix, Inc.
Conditions:
Cataract
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
To monitor intraocular pressure in glaucoma patients after cataract surgery preformed in conjunction with minimally invasive glaucoma surgery (MIGS)
Detailed Description
The purpose of this study is to monitor glaucoma patients intraocular pressure (IOP) after cataract surgery performed in conjunction with minimally invasive glaucoma surgery. After qualifying for this...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04687800
Start Date
December 1 2020
End Date
October 24 2022
Last Update
November 10 2022
Active Locations (1)
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1
The Eye Associates of Manatee
Bradenton, Florida, United States, 34209