Last updated: June 14, 2023
Sponsor: Patrick R. Oellers, MD
Overall Status: Completed
Phase
4
Condition
Inflammation
Treatment
Topical Prednisolone
Dextenza 0.4Mg Ophthalmic Insert
Clinical Study ID
NCT04462523
The ADHERE Study
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Any adult patient age 18-99 years who is planned to undergo vitreo-retinal surgery (pars plana vitrectomy with or without scleral buckle).
- If both eyes are involved, both eyes would be eligible for the study.
- Willing and able to comply with clinic visits and study related procedures.
- Willing and able to sign the informed consent form.
Exclusion
Exclusion Criteria:
- Patients under age 18.
- Patients who are pregnant (must be ruled out in women of child-bearing age withpregnancy test).
- Active infectious ocular or systemic disease.
- Patients with active infectious ocular or extraocular disease.
- Patients actively treated with local or systemic immunosuppression
- Use of the following anti-inflammatory or immunomodulating agents (e.g., cyclosporine)systemically, or in the study eye, for the duration of the study (excludinginhalants). Washout periods for medications prior to surgery are as follows:
- Systemic corticosteroids - 2 weeks (see exception 5c)
- Systemic NSAID over 375 mg per day - 2 weeks
- Periocular/intraocular injection of any corticosteroid solution - 4 weeks (seeexception 5b)
- Corticosteroid depot/implant in the study eye - 2 months
- Topical ocular corticosteroid - 7 days
- Topical ocular NSAID - 7 days
- Intraoperatively used intraocular steroid (i.e. intravitreal triamcinolone, that isused to transiently highlight the vitreous and removed during vitrectomy) ispermissible in study eye.
- Intraoperatively or perioperatively used systemic steroid for the purpose of generalanesthesia (as administered by the treating anesthesiologist) is permissible.
- Patients with systemic illness involving abnormalities of thehypothalamic-pituitary-adrenal axis; patients with primary adrenocorticalinsufficiency or adrenocortical hyperfunction.
- Patients with known hypersensitivity to Dexamethasone.
- Patients with uncontrolled glaucoma.
- Patients with severe disease that warrants critical attention, deemed unsafe for thestudy by the investigator.
Study Design
Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Topical Prednisolone
Phase: 4
Study Start date:
January 03, 2020
Estimated Completion Date:
March 31, 2022
Study Description
Connect with a study center
Retina Vitreous Surgeons of Central New York, PC
Liverpool, New York 13088
United StatesSite Not Available
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