NCT04465864

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

Randomized, Controlled Treatment With an Intracanalicular Dexamethasone (0.4mg) Insert Following Cataract Surgery With IOL Combined With MIGS, Specifically iStent, iStent Inject or KDB in Patients With POAG or Ocular Hypertension (OHTN)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Wolstan and Goldberg Eye Associates · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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)

Detailed description

To determine treatment and patient reported outcomes, following cataract surgery with intraocular lens implant in conjunction with minimally invasive glaucoma surgery (MIGS) more specifically iStent, iStent inject or KDB with an intracanalicular dexamethasone (0.4 mg) insert, inserted four days (+/- 1 day) prior to surgery as compared to insertion on day of surgery. Patients with either primary open angle glaucoma (POAG) or ocular hypertension (OHTN) requiring cataract surgery with IOL implant, will be separated into two groups. Group 1: intracanalicular dexamethasone (0.4 mg) insertion four days (+/- 1 day) prior to cataract surgery with intraocular lens (IOL) implant and MIGS (iStent, iStent inject or KDB) insertion. (Patient to use antibiotic three days prior to surgery) Group 2: intracanalicular dexamethasone (0.4 mg) insertion on the day of cataract surgery with intraocular lens (IOL) implant and MIGS (iStent, iStent inject or KDB) insertion. (Patient to use antibiotic three days prior to surgery)

Conditions

• Glaucoma, Primary Open Angle
• Cataract

Interventions

Type	Name	Description
DRUG	Intracanalicular Dexamethasone, 0.4 mg insert	Intracanalicular Dexamethasone, 0.4 mg insert four days (+/- 1 day) prior to surgery or inserted the day of surgery.

Timeline

• Start date: 2020-02-10
• Primary completion: 2020-12-31
• Completion: 2021-01-31
• First posted: 2020-07-10
• Last updated: 2022-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study