Post-Surgical Ocular Pain, Post-Surgical Ocular Inflammation
Conditions
Keywords
Dexamethasone, Cataract, Capsule Opacification, Inflammation, Lens Diseases, Eye Diseases, Anti-Inflammatory Agents
Brief summary
Assessing DEXTENZA efficacy when placed within the upper eyelid canaliculus as opposed to the lower eyelid canaliculus.
Detailed description
Randomized controlled clinical trial assessing the efficacy of DEXTENZA, sustained release dexamethasone 0.4 mg insert when placed within the upper eye lid canaliculus in comparison to the lower lid canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lens implant (CE/PCIOL).
Interventions
Dextenza 0.4Mg Ophthalmic Insert
Sponsors
Kerry Assil, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All patients will receive: First eye randomized for either lower lid (control eye) or upper lid (study eye) insertion and the contralateral eye receiving the opposite site insertion in the OR following CE/PCIOL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Been diagnosed with clinically significant cataract and CE/PCIOL has been planned * Bilateral cataract surgery with IOL has been planned * Willing and able to comply with clinic visits and study related procedures * Willing and able to sign the informed consent form
Exclusion criteria
* Pregnancy (must be ruled out in women of child-bearing age with pregnancy test) * Active infectious systemic disease * Active infectious ocular or extraocular disease * Obstructed nasolacrimal duct in the study eye(s) * Hypersensitivity to dexamethasone * Patients being treated with immunomodulating agents in the study eye(s) * History of prior ocular surgery, excluding Lasik or PRK * History of ocular inflammation or macular edema * Use of any systemic NSAIDs greater than 375 mg per day * Patients being treated with immunosuppressants and/or oral steroids * Patients with a corticosteroid implant (i.e. Ozurdex) * Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-op pain scores | Assessed on Days 1, 7, 30 for change | As measured on a scale from 0-10 |
| Post-operative inflammation scores | Assessed on Days 1, 7, 30 for change | As measured on a scale of 0-4: absence of cell to be defined as a grade of 0-0.5, absence of flare to be defined as a grade of 0-1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Insertion (successful implantation) | Assessed on Day 0 (Day of Insertion) | As measured by Physician Ease of Use Questionnaire |
| Intraocular Pressure | Assessed on Days 1, 7, 30, 90 for change | As measured by Goldmann Applanation |
| Visual Outcome | Assessed at all time points;comparison of Day 30 vs Day 90 | As measured by BCVA |
| Absence of CME | Assessed on Day -30 to -1 and Day 90 for change | As measured by OCT |
| Need of additional steroids | Assessed on Days 1, 7, 30, 90 for change | As measured by rescue medication added |
| Absence of rebound iritis | Assessed on Days 1, 7, 30, 90 for change | As measured by presence of cells |
| Patient reported outcomes | Assessed on Day 90 | As measured by patient questionnaire |
Countries
United States
Contacts
Primary ContactKellie Burch
Outcome results
None listed