A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment
Overview
- Phase
- Phase 4
- Intervention
- Dextenza 0.4Mg Ophthalmic Insert
- Conditions
- Cataract
- Sponsor
- Wyse Eyecare
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Absence of anterior chamber cells
- Status
- Enrolling by Invitation
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
Arms & Interventions
Dextenza
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).
Intervention: Dextenza 0.4Mg Ophthalmic Insert
Prednisolone Acetate
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: Prednisolone Acetate 1%
Outcomes
Primary Outcomes
Absence of anterior chamber cells
Time Frame: at Day 14
SUN Scale (0 minimum/better to 4 maximum/ worse)
Secondary Outcomes
- BCVA(Baseline (day 8) to day 37)
- Measuring Cell(Day 8, 14, 37)
- Eye Pain(Day 8, 14, 37)
- Ease of Visualization(Day 8, 14, 37)
- Dry Eye(Day 8, Day 14, and Day 37.)
- Central Macular Thickness(Baseline to Day 37)
- Insert Retention(Day 8 to 37 days)
- Number of subjects requiring rescue steroid(Day 8 to Day 37)
- Number of attempts to successfully insertion(Day 8)
- Number and Percentage of subjects with complete absence of cell(Day 8 to 37)
- Measuring Flare(Day 8, 14, 37)
- Ease of insertion(Day 8)