The SITE Study - Dexamethasone Ophthalmic Insert In OR on Day of Surgery Versus In-office Post-Op Day 1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dexamethasone Ophthalmic Insert Day of surgery, in OR placement versus Day 1 Post-Op, In-office (HOPD) |
Drug: Dexamethasone 0.4 MG [Dextenza]
Dextenza
|
Outcome Measures
Primary Outcome Measures
- Anterior Chamber Cells [Assessed on Day 7]
As measured by summed ocular inflammation score (0-4)
- Ocular Pain [Assessed on Day 7]
As measured by ocular pain assessment numerical grading scale (0-10)
Secondary Outcome Measures
- Mean change in BCVA [Assessed on Day -1, Day 7, Day 30]
As measured by snellen VA
- 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)
- 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)
- Physician ease of insertion and visualization [Assessed on Day 1]
As measured by physician questionnaire
Eligibility Criteria
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
-
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Joseph Kavanagh, MD
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SITE-2021-4002