Status:
COMPLETED
Efficacy of Dextenza Insert in Upper vs Lower Punctum Following Cataract Surgery With PCIOL.
Lead Sponsor:
Iworks Laser and Vision Center
Collaborating Sponsors:
Ocular Therapeutix, Inc.
Conditions:
Cataract
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief Summary
To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or withou...
Detailed Description
This is a randomized, controlled study to evaluate the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intr...
Eligibility Criteria
Inclusion
- Subjects will be eligible for study participation if they:
- Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes with or without iStent/Hydrus/Goniotomy.
- Are willing and able to comply with clinic visits and study related procedures.
- Are willing and able to sign the informed consent form.
- Not pregnant.
Exclusion
- Subjects are not eligible for study participation if they:
- Are currently being treated with corticosteroid implant (i.e. Ozurdex).
- Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye.
- Have a history of complete punctal occlusion in one or both punctum.
- Currently use topical ophthalmic steroid medications.
- Are unwilling or unable to comply with the study protocol.
- Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) or if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment.
- Have active infectious systemic disease.
- Have active infectious ocular or extraocular disease.
- Have unobstructed nasolacrimal duct in the study eye(s) (dacrocystitis).
- Have known hypersensitivity to dexamethasone or are a known steroid responder.
- Have a history of ocular inflammation or macular edema.
- Are currently being treated with immunomodulating agents in the study eye(s).
- Are currently being treated with immunosuppressants an/or oral steroids.
- Are Pregnant or breast-feeding or wish to become pregnant during the length of study participation.
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05372315
Start Date
June 15 2022
End Date
October 31 2022
Last Update
August 23 2023
Active Locations (1)
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1
Iworks Laser & Vision Center
Dayton, Ohio, United States, 45405