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The study is being done to measure the absorption of the DEXTENZA implant and inflammation concentration levels in the eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dextenza (Group A) | Experimental | Dextenza (dexamethasone ophthalmic insert 0.4mg) 1-3 days prior to cataract surgery |
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| Dextenza (Group B) | Experimental | Dextenza (dexamethasone ophthalmic insert 0.4mg) 6-8 days prior to surgery |
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| Dextenza (Group C) | Experimental | Dextenza (dexamethasone ophthalmic insert 0.4mg) 13-15 days prior to surgery |
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| Dextenza (Group D) | Experimental | Dextenza (dexamethasone ophthalmic insert 0.4mg) 19-23days prior to surgery |
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| Dextenza (Group E) | Experimental | Dextenza (dexamethasone ophthalmic insert 0.4mg) 26-31 days prior to surgery |
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| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone Ophthalmic implant | Drug | Dexamethasone ophthalmic insert 0.4 mg for intracanalicular use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics in Aqueous Humor Samples | Concentration of dexamethasone in the aqueous humor will be determined by an independent laboratory using standardized high-pressure liquid chromatography and mass spectrometry assasys. Pharmacokinetic parameters determined from aqueous humor concentration will minimally include maximum concentration (Cmax). | Measured 1-3 days, 6-8 days, 13-15 days, 19-23 days, and 26-31 days after Dextenza insertion |
| Pharmacokinetics in Aqueous Humor Samples | Concentration of inflammatory cytokines (IL-1 beta, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p70), IL-13, TNF alpha, and IFN gamma) in the aqueous humor will be determined by an independent laboratory using standardized high-pressure liquid chromatography and mass spectrometry assasys. Pharmacokinetic parameters determined from aqueous humor concentration will minimally include maximum concentration (Cmax). | Measured 1-3 days, 6-8 days, 13-15 days, 19-23 days, and 26-31 days after Dextenza insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between dexamethasone levels and inflammatory cytokines | Test for statistically significant correlations between the aqueous concentrations of dexamethasone and inflammatory cytokines (IL-1 beta, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p70), IL-13, TNF alpha, and IFN gamma) over time | 1-3 days, 6-8 days, 13-15 days, 19-23, or 26-31 days after Dextenza insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank A Bucci, Jr., MD | Bucci Laser Vision Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bucci Laser Vision | Wilkes-Barre | Pennsylvania | 18702 | United States |
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Will not receive Dextenza (dexamethasone ophthalmic insert 0.4mg) |