A Phase 4 interventional study of Dextenza 0.4Mg Ophthalmic Insert in Post-Surgical Ocular Pain and Post-Surgical Ocular Inflammation, sponsored by Kerry Assil, MD. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-19.
Sponsored by Kerry Assil, MD · Phase 4, Interventional, and Treatment
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).
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's planned enrollment of 20 is below the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →This is the only study on the registry with Kerry Assil, MD as lead sponsor.
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Exclusion Criteria:
Dextenza placed within the upper canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation.
Drug: Dextenza 0.4Mg Ophthalmic Insert
Dextenza placed within the lower canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation.
Drug: Dextenza 0.4Mg Ophthalmic Insert
Dextenza 0.4Mg Ophthalmic Insert
Post-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
Patient reported outcomes
As measured by patient questionnaire
Time frame: Assessed on Day 90
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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