Status:
TERMINATED
Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment
Lead Sponsor:
Midwest Eye Institute
Collaborating Sponsors:
Ocular Therapeutix, Inc.
Conditions:
Retinal Detachment
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 outcome...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04464629
Start Date
July 14 2020
End Date
January 25 2023
Last Update
August 16 2023
Active Locations (1)
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1
Midwest Eye Institute
Indianapolis, Indiana, United States, 46290