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).
Overview
- Phase
- Phase 4
- Intervention
- Dextenza 0.4Mg Ophthalmic Insert
- Conditions
- Cataract
- Sponsor
- Iworks Laser and Vision Center
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Participants With Complete Absence of Ocular Pain at Day 8
- Status
- Completed
- Last Updated
- 2 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) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.
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) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.
Investigators
Dr. Patrick Spencer
Principal Investigator
Iworks Laser and Vision Center
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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).
Arms & Interventions
Lower Punctum Insertion (Group 1)
DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use Group 1 (up to 40 eyes) will receive the insert in the lower punctum on the day of surgery in the OR.
Intervention: Dextenza 0.4Mg Ophthalmic Insert
Upper Punctum Insertion (Group 2)
DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use Group 2 (up to 40 eyes) will receive the insert in the upper punctum on the of surgery in the OR.
Intervention: Dextenza 0.4Mg Ophthalmic Insert
Outcomes
Primary Outcomes
Participants With Complete Absence of Ocular Pain at Day 8
Time Frame: at Day 8
Participant reported ocular pain on a scale of (0-10) with zero (0) equaling no pain and ten(10) equaling maximal pain on day 8.
Participants With Zero Cells on Day 14
Time Frame: at Day 14
Proportion of of participants with complete absence of anterior chamber cell at Day 14 as measured by Summed Ocular Inflammation Score (0-4).
Secondary Outcomes
- Ease of Insertion(Day 0)
- Attempts to Achieve Successful Insertion(Day 0)