Phase 4
N=80
Efficacy of Dextenza Insert in Upper vs Lower Punctum Following Cataract Surgery With PCIOL.
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT05372315 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Participants With Complete Absence of Ocular Pain at Day 8 — 39; 39; 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dextenza 0.4Mg Ophthalmic Insert (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Iworks Laser and Vision Center
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Complete Absence of Ocular Pain at Day 8 |
39; 39; 0; 1 | — |
| PRIMARY Participants With Zero Cells on Day 14 |
38; 37; 1; 3 | — |
| SECONDARY Ease of Insertion |
36; 36; 2; 4; 1; 0 | — |
| SECONDARY Attempts to Achieve Successful Insertion |
38; 35; 1; 5 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05372315). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.