Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT04781335
Status:
COMPLETED
Last Update Posted:
2025-02-25
First Post:
2021-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief 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"
Sponsor:
The Eye Institute of West Florida
Organization:
Study Overview
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"
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: