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.
A Randomized, Controlled, Prospective Study design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, TID 1 week, BID 1 week, and QD 1week, following bilateral RLE surgery. All eyes will receive topical moxifloxacin QID for one week and topical Ilevro QD for 4 weeks. Moxifloxacin and Ilevero are used in post-op regardless of the research. Post-operative evaluations to be performed on Day 1, Day 7, and 1 Month.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Dextenza 0.4mg
Standard of care topical drop treatment
Briana Parker
Bozeman, Montana, United States
RECRUITINGPatient 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)
Time frame: Through Month 1
Percentage of eyes that have CME (Cystoid macular edema) post-operatively
Measured by OCT (Optical Coherence Tomography )
Time frame: Through Month 1
Mean pain score per eye (Group A vs Group B)
Measured by Visual Analog Scale (0-10, 10 being the worst outcome)
Time frame: Through Month 1
Incidence of post-operative corneal haze
measured by OCT (Optical Coherence Tomography)
Time frame: Through Month 1
Grade of post-operative corneal haze
measured by OCT (Optical Coherence Tomography)
Time frame: Through Month 1
Anterior chamber cell count
measured by SUN Working Group Grading Scheme
Time frame: Through Month 1
Uncorrected Visual Acuity
measured by ETDRS chart a 4m
Time frame: Through Month 1
Best Corrected Visual Acuity
measured by ETDRS chart a 4m
Time frame: Through Month 1
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