A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment With an Intracanalicular Dexamethasone (0.4mg) Ophthalmic Insert in the Operating Room Following Cataract Surgery/Intraocular Lens Implant (IOL) Compared to Insertion 1-day Post-op - The SITE Study
Overview
- Phase
- Phase 4
- Intervention
- Dexamethasone 0.4 MG [Dextenza]
- Conditions
- Cataract
- Sponsor
- Joseph Kavanagh, MD
- Enrollment
- 50
- Primary Endpoint
- Ocular Pain
- Last Updated
- 4 years ago
Overview
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) compared to insertion 1-day post-op.
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/intraocular lens implant (IOL) compared to insertion 1-day post-op. There will be approximately 50 eyes with two groups: Group 1 (up to 10 eyes) will receive the insert in the lower punctum on the day of surgery in the OR. Group 2 (up to 40 eyes) will receive the insert in the lower punctum on the day after surgery in the HOPD. Each subject's participation is expected to last for approximately 1 month and will be required to complete five scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 7 and Day 30.
Investigators
Joseph Kavanagh, MD
Principal Investigator
Eye Associates of South Texas
Eligibility Criteria
Inclusion Criteria
- •Subjects will be eligible for study participation if they:
- •Are an adult subject aged 65 years or older
- •Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes
- •Are willing and able to comply with clinic visits and study related procedures
- •Are willing and able to sign the informed consent form
Exclusion Criteria
- •Subjects are not eligible for study participation if they:
- •Have active infectious systemic disease
- •Have active infectious ocular or extraocular disease
- •Have unobstructed nasolacrimal duct in the study eye(s)
- •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 and/or oral steroids
- •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
Arms & Interventions
Dexamethasone Ophthalmic Insert
Day of surgery, in OR placement versus Day 1 Post-Op, In-office (HOPD)
Intervention: Dexamethasone 0.4 MG [Dextenza]
Outcomes
Primary Outcomes
Ocular Pain
Time Frame: Assessed on Day 7
As measured by ocular pain assessment numerical grading scale (0-10)
Anterior Chamber Cells
Time Frame: Assessed on Day 7
As measured by summed ocular inflammation score (0-4)
Secondary Outcomes
- Percentage with complete absence of cell(Assessed on Day -1, Day 1, Day 7, Day 30)
- Physician ease of insertion and visualization(Assessed on Day 1)
- Percentage with complete absence of pain(Assessed on Day -1, Day 1, Day 7, Day 30)
- Mean change in BCVA(Assessed on Day -1, Day 7, Day 30)