The SITE Study - Dexamethasone Ophthalmic Insert In OR on Day of Surgery Versus In-office Post-Op Day 1
- Registration Number
- NCT05143281
- Lead Sponsor
- Grene Vision Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- 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
- 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 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexamethasone Ophthalmic Insert Day 1 Post Op Dexamethasone 0.4 MG [Dextenza] Day 1 Post-Op, In-office (HOPD) Dexamethasone Ophthalmic Insert Day of Surgery Dexamethasone 0.4 MG [Dextenza] Day of surgery, in OR placement
- Primary Outcome Measures
Name Time Method Anterior Chamber Cells Assessed on Day 7 As measured by summed ocular inflammation score (0-4 with 4 meaning a worse outcome)
Ocular Pain Assessed on Day 7 As measured by ocular pain assessment numerical grading scale (0-10 with 10 meaning a worse outcome)
- Secondary Outcome Measures
Name Time Method Physician ease of insertion and visualization Assessed on Day 1 As measured by physician questionnaire
Mean change in BCVA Assessed on Day -1, Day 7, Day 30 As measured by snellen VA
Percentage with complete absence of cell Assessed on Day -1, Day 1, Day 7, Day 30 As measured by summed ocular inflammation score (0-4 with 4 meaning a worse outcome)
Percentage with complete absence of pain Assessed on Day -1, Day 1, Day 7, Day 30 As measured by ocular pain assessment numerical grading scale (0-10 with 10 meaning a worse outcome)
Trial Locations
- Locations (1)
Grene Vision Group
🇺🇸Wichita, Kansas, United States