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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04465864
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Glaucoma, Primary Open Angle Cataract Drug: Intracanalicular Dexamethasone, 0.4 mg insert Phase 4

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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
Official Title: 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)
Actual Study Start Date : February 10, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 31, 2021


Arm Intervention/treatment
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)
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.
Other Name: MIGS (iStent, iStent inject or KDB) insertion.

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)
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.
Other Name: MIGS (iStent, iStent inject or KDB) insertion.




Primary Outcome Measures :
  1. Intracanalicular Dexamethasone, 0.4 mg insert four days (+/- 1 day) prior to surgery [ Time Frame: 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 :
  1. Intracanalicular Dexamethasone, 0.4 mg insertion on day of surgery. [ Time Frame: 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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04465864


Contacts
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Contact: Kayla Wiley 310-602-5640 ext 222 tstudy1@wgeye.com
Contact: Jennifer Picone-Jones 310-602-5640 ext 243 tstudy2@wgeye.com

Locations
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United States, California
Wolstan and Goldberg Eye Associates Recruiting
Torrance, California, United States, 90505
Contact: Kayla Wiley    310-602-5640 ext 222    tstudy1@wgeye.com   
Contact: Jennifer Picone-Jones    310-602-5640 ext 243    tstudy2@wgeye.com   
Sponsors and Collaborators
Wolstan and Goldberg Eye Associates
Investigators
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Principal Investigator: Damien Goldberg, MD Wolstan & Goldberg Eye Associates
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Responsible Party: Wolstan and Goldberg Eye Associates
ClinicalTrials.gov Identifier: NCT04465864    
Other Study ID Numbers: DEXTENZA
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Glaucoma, Open-Angle
Glaucoma
Ocular Hypertension
Eye Diseases
Lens Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents