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NCT05372315 | Completed | Cataract

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

Iworks Laser and Vision Center

Information provided by (Responsible Party):

Dr. Patrick Spencer

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.

Condition or disease

Cataract

Intervention/treatment

Dextenza 0.4Mg Ophthalmic Insert

Phase

Phase 4

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.}}

Study Type : Interventional
Estimated Enrollment : 80 participants
Masking : None (Open Label)
Primary Purpose : Treatment
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).
Actual Study Start Date : June 15, 2022
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022
Arm Intervention/treatment

Other: Lower Punctum Insertion (Group 1)

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.

Drug: Dextenza 0.4Mg Ophthalmic Insert

Other: Upper Punctum Insertion (Group 2)

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.

Drug: Dextenza 0.4Mg Ophthalmic Insert
Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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.
Efficacy of Dextenza Insert in Upper vs Lower Punctum Following Cataract Surgery With PCIOL.

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

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Locations

Not yet recruiting

United States, Ohio

Iworks Laser & Vision Center

Dayton, Ohio, United States, 45405