Efficacy of Dextenza Insert in Upper vs Lower Punctum Following Cataract Surgery With PCIOL.

Phase 4

Completed

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.

Recruitment & Eligibility

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).
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 an/or oral steroids.
Are Pregnant or breast-feeding or wish to become pregnant during the length of study participation.

Arm && Interventions

Group	Intervention	Description
Lower Punctum Insertion (Group 1)	Dextenza 0.4Mg Ophthalmic Insert	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.
Upper Punctum Insertion (Group 2)	Dextenza 0.4Mg Ophthalmic Insert	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.

Primary Outcome Measures

Name	Time	Method
Participants With Complete Absence of Ocular Pain at Day 8	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	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 Outcome Measures

Name	Time	Method
Ease of Insertion	Day 0	Rated as Easy, Moderate, Difficult
Attempts to Achieve Successful Insertion	Day 0	Number of attempts to insert the dexamethasone insert in the upper or lower punctum.