Status:
COMPLETED
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Corneal Transplant Surgery
Lead Sponsor:
Nicole Fram M.D.
Conditions:
Corneal Edema
Corneal Defect
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg insert following corneal transplant surgery (PKP, DSEK, DMEK) as compared to topical prednisolone acetate 1%.
Detailed Description
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg insert, when placed within the lower or upper eye lid canaliculus in conjunction with topical prednisolone acetate...
Eligibility Criteria
Inclusion
- A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
- Age 18 years and older
- Scheduled corneal transplant surgery: PKP, DSEK, DMEK
- Willing and able to comply with clinic visits and study related procedures
- Willing and able to sign the informed consent form
Exclusion
- A patient who meets any of the following criteria will be excluded from the study:
- 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
- Presence of punctal plug in the study eye
- Obstructed nasolacrimal duct in the study eye(s)
- Hypersensitivity to dexamethasone or prednisolone eye drops
- 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 :
October 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04521140
Start Date
October 16 2020
End Date
January 4 2023
Last Update
July 24 2023
Active Locations (1)
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1
Advanced Vision Care
Los Angeles, California, United States, 90067