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

  • STATUS
    Recruiting
  • participants needed
    10
  • sponsor
    Midwest Eye Institute
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Updated on 16 February 2024
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retinal detachment
detachment
topical prednisolone
laser surgery

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 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.

Details
Condition Retinal Detachment
Age 18years - 100years
Treatment Prednisolone Acetate, Dextenza
Clinical Study IdentifierNCT04464629
SponsorMidwest Eye Institute
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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