Assessing DEXTENZA efficacy when placed within the upper eyelid canaliculus as opposed to the lower eyelid canaliculus.
Randomized controlled clinical trial assessing the efficacy of DEXTENZA, sustained release dexamethasone 0.4 mg insert when placed within the upper eye lid canaliculus in comparison to the lower lid canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lens implant (CE/PCIOL).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Dextenza 0.4Mg Ophthalmic Insert
Assil Eye Institute
Beverly Hills, California, United States
RECRUITINGPost-operative inflammation scores
As measured on a scale of 0-4: absence of cell to be defined as a grade of 0-0.5, absence of flare to be defined as a grade of 0-1.
Time frame: Assessed on Days 1, 7, 30 for change
Post-op pain scores
As measured on a scale from 0-10
Time frame: Assessed on Days 1, 7, 30 for change
Ease of Insertion (successful implantation)
As measured by Physician Ease of Use Questionnaire
Time frame: Assessed on Day 0 (Day of Insertion)
Intraocular Pressure
As measured by Goldmann Applanation
Time frame: Assessed on Days 1, 7, 30, 90 for change
Visual Outcome
As measured by BCVA
Time frame: Assessed at all time points;comparison of Day 30 vs Day 90
Absence of CME
As measured by OCT
Time frame: Assessed on Day -30 to -1 and Day 90 for change
Need of additional steroids
As measured by rescue medication added
Time frame: Assessed on Days 1, 7, 30, 90 for change
Absence of rebound iritis
As measured by presence of cells
Time frame: Assessed on Days 1, 7, 30, 90 for change
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Patient reported outcomes
As measured by patient questionnaire
Time frame: Assessed on Day 90