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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-10

Study Completion Date

2021-01-31

Brief Summary

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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)

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Detailed Description

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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

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Glaucoma, Primary Open Angle Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Insertion visit 4 days prior

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 Type OTHER

Intracanalicular Dexamethasone, 0.4 mg insert

Intervention Type DRUG

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

Surgical 1 visit day 0

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)

Group Type OTHER

Intracanalicular Dexamethasone, 0.4 mg insert

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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MIGS (iStent, iStent inject or KDB) insertion.

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes