Clinical trial NCT04592081: Dextenza Within Upper Lid Canaliculus Compared With Lower Lid Canaliculus Following Bilateral Cataract Extraction Surgery With 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).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Post-Surgical Ocular Pain
Post-Surgical Ocular Inflammation
Keywords: Dexamethasone
Cataract
Capsule Opacification
Inflammation
Lens Diseases
Eye Diseases
Anti-Inflammatory Agents
Lead sponsor: Assil Eye Institute
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Post-operative inflammation scores
timeFrame: Assessed on Days 1, 7, 30 for change
measure: Post-op pain scores
timeFrame: Assessed on Days 1, 7, 30 for change
Secondary outcomes:
measure: Ease of Insertion (successful implantation)
timeFrame: Assessed on Day 0 (Day of Insertion)
measure: Intraocular Pressure
timeFrame: Assessed on Days 1, 7, 30, 90 for change
measure: Visual Outcome
timeFrame: Assessed at all time points;comparison of Day 30 vs Day 90
measure: Absence of CME
timeFrame: Assessed on Day -30 to -1 and Day 90 for change
measure: Need of additional steroids
timeFrame: Assessed on Days 1, 7, 30, 90 for change
measure: Absence of rebound iritis
timeFrame: Assessed on Days 1, 7, 30, 90 for change
measure: Patient reported outcomes
timeFrame: Assessed on Day 90
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Assil Eye Institute
state: California
Study officials:
affiliation: Assil Eye Institute
name: Kerry Assil, MD
role: PRINCIPAL_INVESTIGATOR
References: