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To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) compared to insertion 1-day post-op.
This is a randomized, controlled study to evaluate the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) compared to insertion 1-day post-op.
There will be approximately 50 eyes with two groups:
Group 1 (up to 10 eyes) will receive the insert in the lower punctum on the day of surgery in the OR.
Group 2 (up to 40 eyes) will receive the insert in the lower punctum on the day after surgery in the HOPD.
Each subject's participation is expected to last for approximately 1 month and will be required to complete five scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 7 and Day 30.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone Ophthalmic Insert | Experimental | Day of surgery, in OR placement versus Day 1 Post-Op, In-office (HOPD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone 0.4 MG [Dextenza] | Drug | Dextenza |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anterior Chamber Cells | As measured by summed ocular inflammation score (0-4) | Assessed on Day 7 |
| Ocular Pain | As measured by ocular pain assessment numerical grading scale (0-10) | Assessed on Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in BCVA | As measured by snellen VA | Assessed on Day -1, Day 7, Day 30 |
| Percentage with complete absence of pain | As measured by ocular pain assessment numerical grading scale (0-10) |
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Inclusion Criteria:
Subjects will be eligible for study participation if they:
Exclusion Criteria:
Subjects are not eligible for study participation if they:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joseph T Kavanagh, MD | Contact | 210-387-0363 | japlh4@gmail.com | |
| Anita Holland | Contact | 210-387-0363 | japlh4@gmail.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Assessed on Day -1, Day 1, Day 7, Day 30 |
| Percentage with complete absence of cell | As measured by summed ocular inflammation score (0-4) | Assessed on Day -1, Day 1, Day 7, Day 30 |
| Physician ease of insertion and visualization | As measured by physician questionnaire | Assessed on Day 1 |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| 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 |