Investigate, Following Cataract Surgery With IOL in Conjunction With Intracanalicular Dexamethasone Insert
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cataract
- Glaucoma Primary Open Angle
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 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)Masking: Single (Participant)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 (+/-...
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)
Tracking Information
- NCT #
- NCT04465864
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Damien Goldberg, MD Wolstan & Goldberg Eye Associates
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