"A Prospective Study of the Efficacy of Intracameral Dexamethasone (Dexycu™) Compared to Standard of Care Treatment for Post-Cataract Surgical Pain and Anterior Chamber Inflammation"

• Status: Recruiting
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Cataract surgery is the most common surgical procedure performed on humans today. The postoperative regimen includes a combination of steroids, NSAIDs (non-steroidal anti-inflammatory drugs) and antibiotics. Those are used to decrease the possibility of infection, inflammation that may lead to corneal and macular edema and pain management. There are several FDA approved agents either for topical use as single drug delivery or combination solutions for topical use as well; furthermore, there are slow release vehicles that may be placed at the time of surgery or postoperatively (at the lower punctum). The latter provides a less intense and demanding drop schedule and may improve patient compliance.

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

Details

• Lead Sponsor: The Eye Institute of West Florida
• Collaborator: EyePoint Pharmaceuticals, Inc.
• Treatments: Anti-Bacterial Agents; Ophthalmic Solutions

Criteria

Inclusion Criteria:

• • Patients age 40 to 90 years old, with visually significant cataract that received bilateral cataract surgery using either the manual technique or femtosecond assisted cataract surgery

Exclusion Criteria:

• • Patients with history of diabetes mellitus and other systemic conditions that may promote inflammation

• patients with previous ocular disease history

• patients with history of ocular surgery

• patients using prescription eye medications topically

• vulnerable subjects or subjects with diminished capacity requiring a POA (Power of Attorney)

• patients with allergies to steroids, NSAID's, or besifloxacin (standard antibiotic)

• women who are pregnant or lactating