Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) 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.
Study Details
Study Description
Brief Summary
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Detailed Description
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
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: DEXTENZA Group Patients undergoing vitrectomy with internal limiting membrane peel |
Drug: Dexamethasone Intracanalicular Insert, 0.4 mg
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
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Experimental: Second DEXTENZA Group Patients undergoing vitrectomy with internal limiting membrane peel |
Drug: Dexamethasone Intracanalicular Insert, 0.4 mg
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
|
Experimental: Topical Prednisolone Acetate 1% Group Patients undergoing vitrectomy with internal limiting membrane peel |
Drug: Prednisone acetate 1%
To reduce post-surgical pain and inflammation in patients who undergo vitrectomy with internal limiting membrane peel surgery
|
Outcome Measures
Primary Outcome Measures
- Mean change in retina edema [assessed on day 30 and day 60]
As measured by Optical Coherence Tomography (OCT)
Secondary Outcome Measures
- Mean change in Inflammation ( Cell and Flare) [as assessed on days 1, 7, 30, 60]
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
- Mean change in pain scores [as assessed on days 1, 7, 30, 60]
as measured with the visual analog scale (VAS); between 0 and 10; 0 meaning no pain and 10 meaning worst pain possible
- Mean Change in Best- Corrected Visual Acuity (BCVA) [from baseline at days 1, 7, 30, 60]
as measured by ETDRS (Early Treatment Diabetic Retinopathy Study) chart
- Physician ease of Dextenza insertion [as assessed on day of surgery]
measured by a 0-10 scale
Eligibility Criteria
Criteria
Inclusion Criteria: A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
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Symptomatic macular pucker with retinal edema
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Age 18 years and older
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Scheduled vitrectomy and internal limiting membrane peel
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Willing and able to comply with clinic visits and study related procedures
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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:
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Patients under the age of 18
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Pregnancy ( must be ruled out in women of child-bearing age with pregnancy test)
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Active infectious systemic disease
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Active infectious ocular or extraocular disease
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Obstructed nasolacrimal duct in the study eye (s)
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Hypersensitivity to dexamethasone or prednisolone eye drops
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Patients being treated with immunomodulating agents in the study eye(s)
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Patient being treated with immunosuppressants and/or oral steroids
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Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Kovach Eye Institute
Investigators
- Principal Investigator: Saad Ahmad, MD, Kovach Eye Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Kovacheye