Back to resultsA Study for Post op Inflammation After Cataract Surgery
Primary Purpose
Cataract
Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dextenza 0.4Mg Ophthalmic Insert
Prednisolone Acetate 1%
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
Inclusion Criteria: Subjects will be eligible for study participation if they: Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes and have a history of epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration. Are willing and able to comply with clinic visits and study related procedures Are willing and able to sign the informed consent form Patients age 18yo+ Exclusion Criteria: Subjects are not eligible for study participation if they: Have active infectious systemic disease Have active infectious ocular or extraocular disease Have an obstructed nasolacrimal duct in the study eye(s) (dacryocystitis) Have known hypersensitivity to dexamethasone or are a known steroid responder Have a history of ocular inflammation or macular edema Are currently being treated with immunomodulating agents in the study eye(s) Are currently being treated with immunosuppressants and/or oral steroids Are currently being treated with corticosteroid implant (i.e. Ozurdex) Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye Have a history of complete punctal occlusion in one or both punctum Currently use topical ophthalmic steroid medications Are currently pregnant or nursing. Are unwilling or unable to comply with the study protocol Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) or if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment
Sites / Locations
- Wyse Eyecare
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dextenza
Prednisolone Acetate
Arm Description
Group 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8).
Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week.
Outcomes
Primary Outcome Measures
Absence of anterior chamber cells
SUN Scale (0 minimum/better to 4 maximum/ worse)
Secondary Outcome Measures
BCVA
Snellen Chart
Number of subjects requiring rescue steroid
Addition of steroid treatment
Number and Percentage of subjects with complete absence of cell
SUN Scale
Measuring Cell
Sun Scale (0 minimum/better to 4 maximum/ worse)
Measuring Flare
Sun Scale (0 minimum/better to 4 maximum/ worse)
Eye Pain
VAS Questionnaire 0 no pain to 10 worst possible pain
Ease of insertion
Noted as Easy, Moderate, or Difficult
Ease of Visualization
Noted as Easy, Moderate, or Difficult
Number of attempts to successfully insertion
Note Number of attempts to successfully insert as 1,2,3 attempts
Dry Eye
SPEED Survey Lower score indicates less dryness which is better than a higher score
Central Macular Thickness
Mean change of Central Macular Thickness by Optical coherence tomography
Insert Retention
By slit lamp exam if insert is visualized or not
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05665270
Brief Title
A Study for Post op Inflammation After Cataract Surgery
Official Title
A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyse Eyecare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized, controlled study to assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert when utilized in conjunction with topical steroids as part of an extended taper steroid regimen following cataract surgery in patients with a history of epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration.
Detailed Description
There will be approximately 40 eyes with two groups:
Group 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8).
Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week.
Both groups will receive topical Prolensa Qa.m. x 5 weeks and Moxifloxacin TID x 1 week, per investigators preferential treatment regimen.
Each subject's participation is expected to last for approximately 5 weeks and subjects will be required to complete six scheduled visits over the course of the study period: Baseline (Screening Visit Day -1), Operative Visit (Day 0), Day 1, Day 8 (insertion day), Day 14, and Day 37.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized, controlled study to assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert when utilized in conjunction with topical steroids as part of an extended taper steroid regimen following cataract surgery in patients with a history of epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration Group 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8).
Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dextenza
Arm Type
Experimental
Arm Description
Group 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8).
Arm Title
Prednisolone Acetate
Arm Type
Active Comparator
Arm Description
Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week.
Intervention Type
Drug
Intervention Name(s)
Dextenza 0.4Mg Ophthalmic Insert
Intervention Description
Group 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8). Both groups will receive topical Prolensa Qa.m. x 5 weeks and Moxifloxacin TID x 1 week, per investigators preferential treatment regimen.
Intervention Type
Drug
Intervention Name(s)
Prednisolone Acetate 1%
Intervention Description
Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week.
Both groups will receive topical Prolensa Qa.m. x 5 weeks and Moxifloxacin TID x 1 week, per investigators preferential treatment regimen.
Primary Outcome Measure Information:
Title
Absence of anterior chamber cells
Description
SUN Scale (0 minimum/better to 4 maximum/ worse)
Time Frame
at Day 14
Secondary Outcome Measure Information:
Title
BCVA
Description
Snellen Chart
Time Frame
Baseline (day 8) to day 37
Title
Number of subjects requiring rescue steroid
Description
Addition of steroid treatment
Time Frame
Day 8 to Day 37
Title
Number and Percentage of subjects with complete absence of cell
Description
SUN Scale
Time Frame
Day 8 to 37
Title
Measuring Cell
Description
Sun Scale (0 minimum/better to 4 maximum/ worse)
Time Frame
Day 8, 14, 37
Title
Measuring Flare
Description
Sun Scale (0 minimum/better to 4 maximum/ worse)
Time Frame
Day 8, 14, 37
Title
Eye Pain
Description
VAS Questionnaire 0 no pain to 10 worst possible pain
Time Frame
Day 8, 14, 37
Title
Ease of insertion
Description
Noted as Easy, Moderate, or Difficult
Time Frame
Day 8
Title
Ease of Visualization
Description
Noted as Easy, Moderate, or Difficult
Time Frame
Day 8, 14, 37
Title
Number of attempts to successfully insertion
Description
Note Number of attempts to successfully insert as 1,2,3 attempts
Time Frame
Day 8
Title
Dry Eye
Description
SPEED Survey Lower score indicates less dryness which is better than a higher score
Time Frame
Day 8, Day 14, and Day 37.
Title
Central Macular Thickness
Description
Mean change of Central Macular Thickness by Optical coherence tomography
Time Frame
Baseline to Day 37
Title
Insert Retention
Description
By slit lamp exam if insert is visualized or not
Time Frame
Day 8 to 37 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects will be eligible for study participation if they:
Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes and have a history of epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration.
Are willing and able to comply with clinic visits and study related procedures
Are willing and able to sign the informed consent form
Patients age 18yo+
Exclusion Criteria:
Subjects are not eligible for study participation if they:
Have active infectious systemic disease
Have active infectious ocular or extraocular disease
Have an obstructed nasolacrimal duct in the study eye(s) (dacryocystitis)
Have known hypersensitivity to dexamethasone or are a known steroid responder
Have a history of ocular inflammation or macular edema
Are currently being treated with immunomodulating agents in the study eye(s)
Are currently being treated with immunosuppressants and/or oral steroids
Are currently being treated with corticosteroid implant (i.e. Ozurdex)
Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye
Have a history of complete punctal occlusion in one or both punctum
Currently use topical ophthalmic steroid medications
Are currently pregnant or nursing.
Are unwilling or unable to comply with the study protocol
Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) or if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment
Facility Information:
Facility Name
Wyse Eyecare
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study for Post op Inflammation After Cataract Surgery
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