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.
NCT ID: NCT04501367
Last Updated: 2023-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2021-04-27
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DEXTENZA Group
Patients undergoing vitrectomy with internal limiting membrane peel
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
Second DEXTENZA Group
Patients undergoing vitrectomy with internal limiting membrane peel
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
Topical Prednisolone Acetate 1% Group
Patients undergoing vitrectomy with internal limiting membrane peel
Prednisone acetate 1%
To reduce post-surgical pain and inflammation in patients who undergo vitrectomy with internal limiting membrane peel surgery
Interventions
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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
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
Prednisone acetate 1%
To reduce post-surgical pain and inflammation in patients who undergo vitrectomy with internal limiting membrane peel surgery
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Kovach Eye Institute
INDUSTRY
Responsible Party
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Principal Investigators
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Saad Ahmad, MD
Role: PRINCIPAL_INVESTIGATOR
Kovach Eye Institute
Locations
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Kovach Eye Institute
Elmhurst, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Kovacheye
Identifier Type: -
Identifier Source: org_study_id
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