About this trial
To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin and risk of cystoid macular edema post-operatively.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Any adult patient who is planned to undergo bilateral RLE surgery with BCVA 20/30 or better
Willing and able to comply with clinic visits and study related procedures
Willing and able to sign the informed consent form
Disqualifiers
Patients under the age of 22 or above the age of 75
Patients who are pregnant (must be ruled out in a women of child-bearing age with pregnancy test).
Patients with active infectious ocular or extraocular disease.
Patients actively treated with local or systemic immunosuppression including systemic corticosteriods
Trial design
Crossover
Treatments tested in this trial
Dextenza
DrugDextenza 0.4mg
Topical Prednisolone
DrugStandard of care topical drop treatment
Treatment groups
Trial outcomes
Primary outcomes
Patient Preference
As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) survey (This is measured on a scale of 1-10 with 10 being a worse outcome)
Secondary outcomes
Percentage of eyes that have CME (Cystoid macular edema) post-operatively
Measured by OCT (Optical Coherence Tomography )
Mean pain score per eye (Group A vs Group B)
Measured by Visual Analog Scale (0-10, 10 being the worst outcome)
Incidence of post-operative corneal haze
measured by OCT (Optical Coherence Tomography)
Grade of post-operative corneal haze
measured by OCT (Optical Coherence Tomography)
Sponsors and contacts
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