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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEXTENZA placed within the upper canaliculus | Experimental | Dextenza placed within the upper canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation. |
|
| DEXTENZA placed within the lower canaliculus | Active Comparator | Dextenza placed within the lower canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextenza 0.4Mg Ophthalmic Insert | Drug | Dextenza 0.4Mg Ophthalmic Insert |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed on Days 1, 7, 30 for change |
| Post-op pain scores | As measured on a scale from 0-10 | Assessed on Days 1, 7, 30 for change |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Insertion (successful implantation) | As measured by Physician Ease of Use Questionnaire | Assessed on Day 0 (Day of Insertion) |
| Intraocular Pressure | As measured by Goldmann Applanation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kellie Burch | Contact | 310-651-2392 | kburch@assileye.com |
| Name | Affiliation | Role |
|---|---|---|
| Kerry Assil, MD | Assil Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assil Eye Institute | Recruiting | Beverly Hills | California | 90210 | United States |
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All patients will receive: First eye randomized for either lower lid (control eye) or upper lid (study eye) insertion and the contralateral eye receiving the opposite site insertion in the OR following CE/PCIOL
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| Assessed on Days 1, 7, 30, 90 for change |
| Visual Outcome | As measured by BCVA | Assessed at all time points;comparison of Day 30 vs Day 90 |
| Absence of CME | As measured by OCT | Assessed on Day -30 to -1 and Day 90 for change |
| Need of additional steroids | As measured by rescue medication added | Assessed on Days 1, 7, 30, 90 for change |
| Absence of rebound iritis | As measured by presence of cells | Assessed on Days 1, 7, 30, 90 for change |
| Patient reported outcomes | As measured by patient questionnaire | Assessed on Day 90 |
| ID | Term |
|---|---|
| D002386 | Cataract |
| D058442 | Capsule Opacification |
| D007249 | Inflammation |
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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