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Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts, when placed within the lower eye lid canaliculus or both the upper and lower canaliculi for the treatment of pain, inflammation, and cystoid macular edema following 27 gauge vitrectomy with internal limiting membrane peel for the treatment of retinal edema associated with macular pucker
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEXTENZA Group | Experimental | Patients undergoing vitrectomy with internal limiting membrane peel |
|
| Second DEXTENZA Group | Experimental | Patients undergoing vitrectomy with internal limiting membrane peel |
|
| Topical Prednisolone Acetate 1% Group | Experimental | Patients undergoing vitrectomy with internal limiting membrane peel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone Intracanalicular Insert, 0.4 mg | Drug | To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with one DEXTENZA (lower eye lid canaliculus) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in retina edema | As measured by Optical Coherence Tomography (OCT) | assessed on day 30 and day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Inflammation ( Cell and Flare) | As measured by SUN (Standardization of Uveitis Nomenclature) grading scale;absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of 0-1 | as assessed on days 1, 7, 30, 60 |
| Mean change in pain scores |
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Inclusion Criteria: A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
Exclusion Criteria: A patient who meets any of the following criteria will be excluded from the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saad Ahmad, MD | Contact | 6308339361 | ifixretinas@gmail.com | |
| Jamie White, Bachelors | Contact | 6308339621 | jamie.white@kovacheye.com |
| Name | Affiliation | Role |
|---|---|---|
| Saad Ahmad, MD | Kovach Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kovach Eye Institute | Recruiting | Elmhurst | Illinois | 60126 | United States |
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In patients who undergo vitrectomy with internal limiting membrane peel surgery , subjects will be randomized to three groups and be followed for a period of two months. One group will be selected to receive one DEXTENZA (in the lower canaliculus), the second group will receive two DEXTENZA (upper and lower canaliculi) and the third group will receive prednisolone acetate 1% (control eye) . All groups will receive a subconjunctival dexamethasone injection at the time of surgery.
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|
| Dexamethasone Intracanalicular Insert, 0.4 mg | Drug | To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with two DEXTENZA (upper and lower canaliculi) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery |
|
| Prednisone acetate 1% | Drug | To reduce post-surgical pain and inflammation in patients who undergo vitrectomy with internal limiting membrane peel surgery |
|
as measured with the visual analog scale (VAS); between 0 and 10; 0 meaning no pain and 10 meaning worst pain possible |
| as assessed on days 1, 7, 30, 60 |
| Mean Change in Best- Corrected Visual Acuity (BCVA) | as measured by ETDRS (Early Treatment Diabetic Retinopathy Study) chart | from baseline at days 1, 7, 30, 60 |
| Physician ease of Dextenza insertion | measured by a 0-10 scale | as assessed on day of surgery |
| ID | Term |
|---|---|
| D019773 | Epiretinal Membrane |
| D010211 | Papilledema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
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