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

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Intracanalicular Dexamethasone, 0.4 mg insert

About this trial

This is an interventional treatment trial for Glaucoma, Primary Open Angle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Wolstan and Goldberg Eye Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Insertion visit 4 days prior

Surgical 1 visit day 0

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Intracanalicular Dexamethasone, 0.4 mg insert four days (+/- 1 day) prior to surgery

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

Intracanalicular Dexamethasone, 0.4 mg insertion on day of surgery.

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

Full Information

NCT ID

NCT04465864

First Posted

February 12, 2020

Last Updated

August 18, 2022

Sponsor

Wolstan and Goldberg Eye Associates

1. Study Identification

Unique Protocol Identification Number

NCT04465864

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

February 10, 2020 (Actual)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wolstan and Goldberg Eye Associates

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Primary Open Angle, Cataract

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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

Participant

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Insertion visit 4 days prior

Arm Type

Other

Arm Description

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)

Arm Title

Surgical 1 visit day 0

Arm Type

Other

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

Intracanalicular Dexamethasone, 0.4 mg insert

Other Intervention Name(s)

MIGS (iStent, iStent inject or KDB) insertion.

Intervention Description

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

Primary Outcome Measure Information:

Title

Intracanalicular Dexamethasone, 0.4 mg insert four days (+/- 1 day) prior to surgery

Description

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)

Time Frame

four days (+/- 1 day) prior to surgery with visits scheduled at day 1, day 7, day 14, day 30, and day 45.

Secondary Outcome Measure Information:

Title

Intracanalicular Dexamethasone, 0.4 mg insertion on day of surgery.

Description

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

Time Frame

insertion on day of surgery with scheduled visits on day 1, day 7, day 14, day 30, and day 45.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Damien Goldberg, MD

Organizational Affiliation

Wolstan & Goldberg Eye Associates

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wolstan and Goldberg Eye Associates

City

Torrance

State/Province

California

ZIP/Postal Code

90505

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

Glaucoma, Primary Open Angle, Cataract

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial