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

Phase 4

Completed

• Conditions: Glaucoma, Primary Open Angle; Cataract
• Interventions: Drug: Intracanalicular Dexamethasone, 0.4 mg insert

• Registration Number: NCT04465864
• Lead Sponsor: Wolstan and Goldberg Eye Associates

Brief 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)

Study Timeline

• Study Start: 2020-02-10
• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-10
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-18
• Last Update Posted: 2022-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insertion visit 4 days prior	Intracanalicular Dexamethasone, 0.4 mg insert	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)
Surgical 1 visit day 0	Intracanalicular Dexamethasone, 0.4 mg insert	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)

Primary Outcome Measures

Name	Time	Method
Intracanalicular Dexamethasone, 0.4 mg insert four days (+/- 1 day) prior to surgery	four days (+/- 1 day) prior to surgery with visits scheduled at day 1, day 7, day 14, day 30, and day 45.	Primary: Will receive the insert four days (+/- 1 day) prior to surgery. Each enrolled subject will be required to complete seven scheduled visits over the course of the study period: Baseline, insertion visit, operative visit, Day 1, 7, 30, and a 14 \& 45-day phone call.; Absence of cells in anterior chamber at day 7 as measured by: Summed Ocular Inflammation Score (0-4) Absence of cell to be defined as a grade of (0-0.5) Absence of pain at Day 7 (score of 0) as measured by ocular pain assessment numerical grading scale 0-10 Mean change in BCVA from baseline (Day 7,30) Mean change in OCT from baseline (Day 30) Physician ease of intracanalicular insertion evaluation as measured by physician questionnaire Incidence and severity of ocular and systemic AE's (Day 1,7,14,30,45)

Secondary Outcome Measures

Name	Time	Method
Intracanalicular Dexamethasone, 0.4 mg insertion on day of surgery.	insertion on day of surgery with scheduled visits on day 1, day 7, day 14, day 30, and day 45.	Secondary: Will receive the insert on the day of surgery. Each enrolled study subject will be required to complete six scheduled visits over the course of the study period: Screening visit, operative/insertion visit, Day 1, 7, 30, and a 14 \& 45 day phone call.; Measuring cell, pain and flare at (Day 1,30) Absence of cell to be defined as a grade of (0-0.5) Absence of flare to be defined as a grade of (0-1) Determining if call backs have decreased at the clinic with study patients

Trial Locations

Locations (1)

Wolstan and Goldberg Eye Associates; 🇺🇸 Torrance, California, United States