Clinical trial NCT04781335: "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"
Official title: "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"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: Cataract
Dexycu
Lead sponsor: The Eye Institute of West Florida
Sponsor class: OTHER
Collaborators: name: EyePoint Pharmaceuticals, Inc.
First posted: 2021-03-04
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Pain score
timeFrame: post operative day 1
measure: Pain score
timeFrame: post operative day 7
measure: Pain score
timeFrame: post operative day 30
measure: Inflammation Score
timeFrame: post operative day 1
measure: Inflammation Score
timeFrame: post operative day 7
measure: Inflammation Score
timeFrame: post operative day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Largo
country: United States
facility: The Eye Institute of West Florida
state: Florida
Study officials:
affiliation: The Eye Institute of West Florida
name: Robert J Weinstock, MD
role: PRINCIPAL_INVESTIGATOR
References: