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To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin and risk of cystoid macular edema post-operatively.
A Randomized, Controlled, Prospective Study design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, TID 1 week, BID 1 week, and QD 1week, following bilateral RLE surgery. All eyes will receive topical moxifloxacin QID for one week and topical Ilevro QD for 4 weeks. Moxifloxacin and Ilevero are used in post-op regardless of the research. Post-operative evaluations to be performed on Day 1, Day 7, and 1 Month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A Dextenza | Active Comparator | Drug: Dextenza 0.4mg Opthalmic Insert The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion, The attributes of the insert reduce risks for improper corticosteriod tapering and unwanted peaks and troughs in drug concentration. |
|
| Group B Topical Prednisolone | Active Comparator | Drug: Topical Prednisolone Standard of care topical drop treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextenza | Drug | Dextenza 0.4mg |
| |
| Topical Prednisolone |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Preference | As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) survey (This is measured on a scale of 1-10 with 10 being a worse outcome) | Through Month 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of eyes that have CME (Cystoid macular edema) post-operatively | Measured by OCT (Optical Coherence Tomography ) | Through Month 1 |
| Mean pain score per eye (Group A vs Group B) | Measured by Visual Analog Scale (0-10, 10 being the worst outcome) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Briana Parker | Recruiting | Bozeman | Montana | 59718 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 1, 2023 | Aug 28, 2023 | 1 |
| ID | Term |
|---|---|
| D057240 | Patient Preference |
| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
Standard of care topical drop treatment |
|
| Through Month 1 |
| Incidence of post-operative corneal haze | measured by OCT (Optical Coherence Tomography) | Through Month 1 |
| Grade of post-operative corneal haze | measured by OCT (Optical Coherence Tomography) | Through Month 1 |
| Anterior chamber cell count | measured by SUN Working Group Grading Scheme | Through Month 1 |
| Uncorrected Visual Acuity | measured by ETDRS chart a 4m | Through Month 1 |
| Best Corrected Visual Acuity | measured by ETDRS chart a 4m | Through Month 1 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |