Status:
UNKNOWN
DEXTENZA VS. PREDNISOLONE ACETATE 1% Macular Edema With Diabetic Retinopathy After Cataract Surgery
Lead Sponsor:
Ophthalmic Consultants of the Capital Region
Conditions:
Retinopathy, Diabetic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The complicated schedules for administering topical steroid eye drops combined with forgetfulness and physical difficulties instilling the drops may compromise compliance; which in turn could increase...
Detailed Description
This prospective, open-label, single-center, randomized, fellow-eye, investigator-sponsored clinical study seeks to investigate the incidence of PME in diabetic patients with any level of background d...
Eligibility Criteria
Inclusion
- Binocular
- \>18 years old
- Any level of Background Diabetic Retinopathy
- Cataract surgery candidate in each eye
- Pre-operative OCT and Fluorescein Angiography showing no Macular edema
Exclusion
- Participant cannot complete second eye operation within 60 days of the first cataract surgery
- Maintains regular use of systemic or ocular steroids at time of enrollment
- Maintains regular use of systemic or ocular non-steroidal anti-inflammatory drugs at time of enrollment
- Anterior chamber cells present at time of enrollment
- Recent febrile illness that precludes or delays participation for 90 days
- Pregnancy or lactation
- Known allergy to dexamethasone
- Known allergy to prednisolone
- Preexisting retinal disease including uveitis, nondiabetic retinal disease, choroidal disorders, diabetic macular edema.
- Posterior capsule rupture or other intraoperative complication in first eye operated on
- Amblyopia
- Anti-VEGF injections within 6 months prior to surgery day.
- Intraocular steroid injection within 6 months prior to surgery day.
- Intraocular surgeries within 6 months prior to surgery day.
- Laser photocoagulation within 30 days prior to surgery day.
- Any type of eye inflammation
- Any punctum inflammation or dacryocystitis
Key Trial Info
Start Date :
August 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04362241
Start Date
August 7 2020
End Date
March 1 2022
Last Update
August 11 2020
Active Locations (1)
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1
Ophthalmic Consultants of the Capital Region
Troy, New York, United States, 12180