TrialX
Image

Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment

Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment

Recruiting
18 years and older
All
Phase 4

Overview

This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate: how will pseudophakic patients respond in terms of objective and subjective outcomes, when treated with Dextenza compared to topical prednisolone acetate following gas bubble repair and laser for RD.

Description

Subjects who have given informed consent and determined to be eligible at screening will be randomized in a 1:1 ratio to DEXTENZA (placed once in the lower punctum) or the use of topical Prednisolone acetate 1% drops (four times daily). They will be observed for a period of 3-months for both pain and inflammation of the eye.

Eligibility

Inclusion Criteria:

  • Pseudophakic
  • Retinal Detachment
  • Age 18 years and older
  • Scheduled for gas bubble repair and laser surgery following retinal detachment
  • Willing and able to comply with clinic visits and study related procedures
  • Willing and able to sign the informed consent form

Exclusion Criteria:

  • Patients under the age of 18.
  • Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
  • Active infectious systemic disease
  • Active infectious ocular or extraocular disease
  • Obstructed nasolacrimal duct in the study eye(s)
  • Hypersensitivity to dexamethasone
  • Patients being treated with immunomodulating agents in the study eye(s)
  • Patients being treated with immunosuppressants and/or oral steroids
  • Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Study details
    Retinal Detachment

NCT04464629

Midwest Eye Institute

16 February 2024

Step 1 Get in touch with the nearest study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team


Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.