The purpose of this study is to evaluate efficacy and safety of Dextenza for the treatment of postoperative pain and inflammation following vitreo-retinal surgery
This prospective, single-center, open-label, investigator-sponsored clinical study seeks to investigate the outcomes of patients undergoing vitro-retinal surgery with the treatment of a dexamethasone intracanalicular insert. All patients in the treatment groups will receive a dexamethasone intracanalicular insert. There will be three experimental groups of patients, varying that time of insertion. Ten patients will receive the dexamethasone intracanalicular insert pre-operatively (1 week to 1 days prior to vitreo-retinal surgery). Ten patients will receive dexamethasone intracanalicular insert on the day of surgery. Ten patients will receive DEXTENZA insert Day 1 post-operatively. Ten patients will be prescribed standard of care ophthalmic drops, Prednisolone Acetate, and no dexamethasone insert (control group). All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.
Standard of care topical drop treatment
Retina Vitreous Surgeons of Central New York, PC
Liverpool, New York, United States
Mean cells as assessed by investigator in anterior chamber of the study eye
As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)
Time frame: Assessed at Day 14
Mean pain as reported by subject in the study eye: Visual Analog Scale
As measured by Visual Analog Scale for Pain (VAS Pain) (0% to 100% Scale)
Time frame: Assessed at Day 28
Mean anterior chamber flare
As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)
Time frame: Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
Time to absence of cells
As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)
Time frame: Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
Time to absence of pain
As measure by Visual Analog Scale for Pain (VAS Pain) (0% to 100% Scale)
Time frame: Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
Proportion of rescue treatment
As measure by Concomitant Medications as rescue therapy
Time frame: Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
Assessment of Dextenza ease of insertion
As measured by Ease of Use Survey (0=very easy to 10=very hard)
Time frame: Assessed at Day 1
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