Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 20
Summary
- Conditions
- Cataract
- Glaucoma
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This prospective study will enroll 40 eyes from a variable number of total patients. The total patient number may vary due to some binocular enrollment from patients who meet eligibility criteria in both eyes. All eyes will receive concomitant cataract and MIGS surgery. Each eye will be randomized to receive either DEXTENZA® insertion at the end of the surgery or to a standard of care prednisolone acetate 1% eye drop regimen. All eyes will receive the standard of care topical ofloxacin antibiotic regimen. The experimental group will consist of the 20 eyes receiving DEXTENZA® insertion. The control group will consist of the 20 eyes placed on the prednisolone eye drop regimen.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 125 years
- Gender
- Both males and females
Description
Glaucoma and cataract surgery patients face an outsize postoperative burden. In addition to taking frequent anti-inflammatory eye drops, they often continue their glaucoma medications. This can cause patient confusion and nonadherence, potentially leading to poor healing, slower recovery period, and...
Glaucoma and cataract surgery patients face an outsize postoperative burden. In addition to taking frequent anti-inflammatory eye drops, they often continue their glaucoma medications. This can cause patient confusion and nonadherence, potentially leading to poor healing, slower recovery period, and/or cystoid macular edema. DEXTENZA®, as a sustained release anti-inflammatory insert, could help preclude adherence difficulties and increase comfort by reducing eye drop load. However, glaucoma surgeons may hesitate to adopt DEXTENZA® due to concerns regarding safety with respect to elevated intraocular pressure. This prospective study will address those concerns directly, providing timely and high-quality clinical evidence comparing DEXTENZA® to standard-of-care steroid eye drops. For physicians and patients, the results of this study will prove immediately useful for therapeutic decision-making.
Tracking Information
- NCT #
- NCT04200651
- Collaborators
- Ocular Therapeutix, Inc.
- Investigators
- Principal Investigator: Nathan M Radcliffe, MD New York Eye Surgery Center; New York Eye and Ear Infirmary of Mount Sinai
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