A Study for Post op Inflammation After Cataract Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment

Conditions
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Cataract

Intervention / Treatment
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* Drug: Dextenza 0.4Mg Ophthalmic Insert
* Drug: Prednisolone Acetate 1%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dextenza<br>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). | Drug: Dextenza 0.4Mg Ophthalmic Insert<br>* 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.<br>|
| Active Comparator: Prednisolone Acetate<br>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. | Drug: Prednisolone Acetate 1%<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of anterior chamber cells | SUN Scale (0 minimum/better to 4 maximum/ worse) | at Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCVA | Snellen Chart | Baseline (day 8) to day 37 | 
| Number of subjects requiring rescue steroid | Addition of steroid treatment | Day 8 to Day 37 | 
| Number and Percentage of subjects with complete absence of cell | SUN Scale | Day 8 to 37 | 
| Measuring Cell | Sun Scale (0 minimum/better to 4 maximum/ worse) | Day 8, 14, 37 | 
| Measuring Flare | Sun Scale (0 minimum/better to 4 maximum/ worse) | Day 8, 14, 37 | 
| Eye Pain | VAS Questionnaire 0 no pain to 10 worst possible pain | Day 8, 14, 37 | 
| Ease of insertion | Noted as Easy, Moderate, or Difficult | Day 8 | 
| Ease of Visualization | Noted as Easy, Moderate, or Difficult | Day 8, 14, 37 | 
| Number of attempts to successfully insertion | Note Number of attempts to successfully insert as 1,2,3 attempts | Day 8 | 
| Dry Eye | SPEED Survey Lower score indicates less dryness which is better than a higher score | Day 8, Day 14, and Day 37. | 
| Central Macular Thickness | Mean change of Central Macular Thickness by Optical coherence tomography | Baseline to Day 37 | 
| Insert Retention | By slit lamp exam if insert is visualized or not | Day 8 to 37 days |