Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts, when placed within the lower eye lid canaliculus or both the upper and lower canaliculi for the treatment of pain, inflammation, and cystoid macular edema following 27 gauge vitrectomy with internal limiting membrane peel for the treatment of retinal edema associated with macular pucker
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with one DEXTENZA (lower eye lid canaliculus) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery
To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with two DEXTENZA (upper and lower canaliculi) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery
To reduce post-surgical pain and inflammation in patients who undergo vitrectomy with internal limiting membrane peel surgery
Kovach Eye Institute
Elmhurst, Illinois, United States
RECRUITINGMean change in retina edema
As measured by Optical Coherence Tomography (OCT)
Time frame: assessed on day 30 and day 60
Mean change in Inflammation ( Cell and Flare)
As measured by SUN (Standardization of Uveitis Nomenclature) grading scale;absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of 0-1
Time frame: as assessed on days 1, 7, 30, 60
Mean change in pain scores
as measured with the visual analog scale (VAS); between 0 and 10; 0 meaning no pain and 10 meaning worst pain possible
Time frame: as assessed on days 1, 7, 30, 60
Mean Change in Best- Corrected Visual Acuity (BCVA)
as measured by ETDRS (Early Treatment Diabetic Retinopathy Study) chart
Time frame: from baseline at days 1, 7, 30, 60
Physician ease of Dextenza insertion
measured by a 0-10 scale
Time frame: as assessed on day of surgery
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