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

Iworks Laser and Vision Center

Status and phase: Completed; Phase 4

Conditions: Cataract

Treatments: Drug: Dextenza 0.4Mg Ophthalmic Insert

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05372315

SPENCER-2022-401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Lower Punctum Insertion (Group 1)

Other group

Description:

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.

Treatment:

Drug: Dextenza 0.4Mg Ophthalmic Insert

Upper Punctum Insertion (Group 2)

Other group

Description:

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.

Treatment:

Drug: Dextenza 0.4Mg Ophthalmic Insert