Vitrectomy Clinical Trial
Official title:
Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) 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.
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: A patient's study eye must meet the following criteria to be eligible for inclusion in the study: - Symptomatic macular pucker with retinal edema - Age 18 years and older - Scheduled vitrectomy and internal limiting membrane peel - Willing and able to comply with clinic visits and study related procedures - Willing and able to sign the informed consent form Exclusion Criteria: A patient who meets any of the following criteria will be excluded from the study: - Patients under the age of 18 - Pregnancy ( must be ruled out in women of child-bearing age with pregnancy test) - Active infectious systemic disease - Active infectious ocular or extraocular disease - Obstructed nasolacrimal duct in the study eye (s) - Hypersensitivity to dexamethasone or prednisolone eye drops - Patients being treated with immunomodulating agents in the study eye(s) - Patient being treated with immunosuppressants and/or oral steroids - Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator |
Country | Name | City | State |
---|---|---|---|
United States | Kovach Eye Institute | Elmhurst | Illinois |
Lead Sponsor | Collaborator |
---|---|
Kovach Eye Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change in retina edema | As measured by Optical Coherence Tomography (OCT) | assessed on day 30 and day 60 | |
Secondary | 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 | |
Secondary | Mean change in pain scores | 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 | |
Secondary | 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 | |
Secondary | Physician ease of Dextenza insertion | measured by a 0-10 scale | as assessed on day of surgery |
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