Clinical trial NCT05372315: Efficacy of Dextenza Insert in Upper vs Lower Punctum Following Cataract Surgery With PCIOL.
Official title: A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment With an Intracanalicular Dexamethasone (0.4mg) Ophthalmic Insert in the Operating Room Following Cataract Surgery/Intraocular Lens Implant (IOL).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: PCIOL
CCI CE
Lead sponsor: Iworks Laser and Vision Center
Sponsor class: OTHER
Collaborators: name: Ocular Therapeutix, Inc.
First posted: 2022-05-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Each subject's participation is expected to last for approximately 1 month and will be required to complete six scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 8, Day 14 and Day 30.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Participants With Complete Absence of Ocular Pain at Day 8
timeFrame: at Day 8
measure: Participants With Zero Cells on Day 14
timeFrame: at Day 14
Secondary outcomes:
measure: Ease of Insertion
timeFrame: Day 0
measure: Attempts to Achieve Successful Insertion
timeFrame: Day 0
Other outcomes:
Locations:
city: Dayton
country: United States
facility: Iworks Laser & Vision Center
state: Ohio
Study officials:
affiliation: Iworks Laser & Vision Center
name: Patrick L Spencer, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greenwood MD, Gorham RA, Boever KR. A Randomized Fellow-Eye Clinical Trial to Evaluate Patient Preference for Dexamethasone Intracanalicular Insert or Topical Prednisolone Acetate for Control of Postoperative Symptoms Following Bilateral Femtosecond Laser in Site Keratomileusis (LASIK). Clin Ophthalmol. 2020 Aug 6;14:2223-2228. doi: 10.2147/OPTH.S265311. eCollection 2020.