"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"

Phase

Condition

Inflammation

Vision Loss

Eye Disorders/infections

Treatment

Standard of Care post operative eye drops (steroid, antibiotic, NSAID)

Dexycu

Clinical Study ID

NCT04781335

EIWF-EP001

Ages 40-90
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

• Patients with history of diabetes mellitus and other systemic conditions that maypromote 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 (Powerof Attorney)
patients with allergies to steroids, NSAID's, or besifloxacin (standardantibiotic)
women who are pregnant or lactating

Study Design

Standard of Care post operative eye drops (steroid, antibiotic, NSAID)

February 20, 2020

December 22, 2022

Study Description

The current study will assess post cataract the efficacy and safety of two different FDA approved regimens, which include the standard of care (topical steroids, NSAIDs and antibiotics) or Intracameral Dexamethasone (Dexycu™) along with topical NSAIDs and antibiotics.

The hypothesis of the current study is that topical steroids or intracamerally injected steroids as slow release vehicles, demonstrate the same efficacy of controlling post cataract pain and inflammation. We will assess one objective outcome measure, anterior chamber inflammation. This will provide a direct index of the efficacy of the steroidal agents used. Furthermore, a subjective outcome measure, ocular pain, will also be assessed. In cases where a patient in either of the two groups has sever inflammation, rescue medications will be applied, increasing the dosage of topical steroidal agents and the patient will be followed closely until resolved.

The study will include 50 consecutive patients, men and women ages 40 to 90 years old, with visually significant cataract that received bilateral cataract surgery using either the manual technique or femtosecond assisted cataract surgery. Bilateral surgery is common practice and is not performed on the same day. There is a one week time interval between the eyes receiving cataract extraction. The patients that we will enroll in the suggested study will require and will receive bilateral cataract surgery with one week time interval between the two eyes. There are no restrictions on racial or ethnic origin. Employees of The Eye Institute of West Florida will not be enrolled into this study.

Connect with a study center

The Eye Institute of West Florida
Largo, Florida 33770
United States
Site Not Available

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