Investigate, Following Cataract Surgery With IOL in Conjunction With Intracanalicular Dexamethasone Insert

• Status: Recruiting
• Trial end date: 2021-01-31
• Target enrollment: 0
• Participant gender: All

Summary

Randomized, controlled treatment with an intracanalicular dexamethasone (0.4mg) insert following cataract surgery with intraocular lens implant (IOL) combined with minimally invasive glaucoma surgery (MIGS), specifically iStent, iStent inject or KDB in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHTN)

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wolstan and Goldberg Eye Associates
• Treatments: Dexamethasone

Criteria

Inclusion Criteria:

• Age 18 years and older

• Been diagnosed with POAG or OHTN and MIGS (iStent, iStent inject or KDB) has been planned

• Unilateral or bilateral cataract surgery with IOL has been planned

• Willing and able to comply with clinic visits and study related procedures

• Willing and able to sign the informed consent form

Exclusion Criteria:

• Patients under the age of 18.

• Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)

• Active infectious systemic disease

• Active infectious ocular or extraocular disease

• Unobstructed nasolacrimal duct in the study eye(s)

• Hypersensitivity to dexamethasone

• Patients being treated with immunomodulating agents in the study eye(s)

• History of prior ocular surgery, including Lasik or PRK

• History of ocular inflammation or macular edema

• Patients being treated with >375mg daily of NSAIDs

o Patients on doses higher than 375mg of oral NSAIDs will be considered if they discontinue the medication 2 weeks prior to the study start date.

• Patients taking inconsistent varying doses of an NSAID on a daily basis.

• Patients being treated with immunosuppressants and/or oral steroids

• Patients with a corticosteroid implant (i.e. Ozurdex)

• Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator