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

Iworks Laser and Vision Center80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cataract

Interventions

Dextenza 0.4Mg Ophthalmic InsertDRUG

(dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Subjects will be eligible for study participation if they: 1. Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes with or without iStent/Hydrus/Goniotomy. 2. Are willing and able to comply with clinic visits and study related procedures. 3. Are willing and able to sign the informed consent form. 4. Not pregnant. Exclusion Criteria: Subjects are not eligible for study participation if they: 1. Are currently being treated with corticosteroid implant (i.e. Ozurdex). 2. Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye. 3. Have a history of complete punctal occlusion in one or both punctum. 4. Currently use topical ophthalmic steroid medications. 5. Are unwilling or unable to comply with the study protocol. 6. 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. 7. Have active infectious systemic disease. 8. Have active infectious ocular or extraocular disease. 9. Have unobstructed nasolacrimal duct in the study eye(s) (dacrocystitis). 10. Have known hypersensitivity to dexamethasone or are a known steroid responder. 11. Have a history of ocular inflammation or macular edema. 12. Are currently being treated with immunomodulating agents in the study eye(s). 13. Are currently being treated with immunosuppressants an/or oral steroids. 14. Are Pregnant or breast-feeding or wish to become pregnant during the length of study participation.

Locations (1)

Iworks Laser & Vision Center

Dayton, Ohio, United States

Outcomes

Primary Outcomes

Participants With Complete Absence of Ocular Pain 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.

Time frame: at Day 8

Participants With Zero Cells on 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).

Time frame: at Day 14

Secondary Outcomes

Ease of Insertion

Rated as Easy, Moderate, Difficult

Time frame: Day 0

Attempts to Achieve Successful Insertion

Number of attempts to insert the dexamethasone insert in the upper or lower punctum.

Time frame: Day 0

Data from ClinicalTrials.gov

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