Dextenza Within Upper Lid Canaliculus Compared With Lower Lid Canaliculus Following Bilateral Cataract Extraction Surgery With PCIOL.

Study Overview
=================
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).

Official Title
-----------------
A 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).

Conditions
-----------------
Post-Surgical Ocular Pain, Post-Surgical Ocular Inflammation

Intervention / Treatment
-----------------
* Drug: Dextenza 0.4Mg Ophthalmic Insert


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEXTENZA placed within the upper canaliculus<br>Dextenza placed within the upper canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation. | Drug: Dextenza 0.4Mg Ophthalmic Insert<br>* Dextenza 0.4Mg Ophthalmic Insert<br>|
| Active Comparator: DEXTENZA placed within the lower canaliculus<br>Dextenza placed within the lower canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation. | Drug: Dextenza 0.4Mg Ophthalmic Insert<br>* Dextenza 0.4Mg Ophthalmic Insert<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative inflammation scores | 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. | Assessed on Days 1, 7, 30 for change | 
| Post-op pain scores | As measured on a scale from 0-10 | Assessed on Days 1, 7, 30 for change | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Insertion (successful implantation) | As measured by Physician Ease of Use Questionnaire | Assessed on Day 0 (Day of Insertion) | 
| Intraocular Pressure | As measured by Goldmann Applanation | Assessed on Days 1, 7, 30, 90 for change | 
| Visual Outcome | As measured by BCVA | Assessed at all time points;comparison of Day 30 vs Day 90 | 
| Absence of CME | As measured by OCT | Assessed on Day -30 to -1 and Day 90 for change | 
| Need of additional steroids | As measured by rescue medication added | Assessed on Days 1, 7, 30, 90 for change | 
| Absence of rebound iritis | As measured by presence of cells | Assessed on Days 1, 7, 30, 90 for change | 
| Patient reported outcomes | As measured by patient questionnaire | Assessed on Day 90 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dexamethasone, Cataract, Capsule Opacification, Inflammation, Lens Diseases, Eye Diseases, Anti-Inflammatory Agents