Cataract
Conditions
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.
Interventions
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.
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.
Sponsors
Wyse Eyecare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subjects will be eligible for study participation if they: 1. 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. 2. Are willing and able to comply with clinic visits and study related procedures 3. Are willing and able to sign the informed consent form 4. Patients age 18yo+
Exclusion criteria
Subjects are not eligible for study participation if they: 1. Have active infectious systemic disease 2. Have active infectious ocular or extraocular disease 3. Have an obstructed nasolacrimal duct in the study eye(s) (dacryocystitis) 4. Have known hypersensitivity to dexamethasone or are a known steroid responder 5. Have a history of ocular inflammation or macular edema 6. Are currently being treated with immunomodulating agents in the study eye(s) 7. Are currently being treated with immunosuppressants and/or oral steroids 8. Are currently being treated with corticosteroid implant (i.e. Ozurdex) 9. Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye 10. Have a history of complete punctal occlusion in one or both punctum 11. Currently use topical ophthalmic steroid medications 12. Are currently pregnant or nursing. 13. Are unwilling or unable to comply with the study protocol 14. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of anterior chamber cells | at Day 14 | SUN Scale (0 minimum/better to 4 maximum/ worse) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects requiring rescue steroid | Day 8 to Day 37 | Addition of steroid treatment |
| Number and Percentage of subjects with complete absence of cell | Day 8 to 37 | SUN Scale |
| Measuring Cell | Day 8, 14, 37 | Sun Scale (0 minimum/better to 4 maximum/ worse) |
| Measuring Flare | Day 8, 14, 37 | Sun Scale (0 minimum/better to 4 maximum/ worse) |
| Eye Pain | Day 8, 14, 37 | VAS Questionnaire 0 no pain to 10 worst possible pain |
| BCVA | Baseline (day 8) to day 37 | Snellen Chart |
| Ease of Visualization | Day 8, 14, 37 | Noted as Easy, Moderate, or Difficult |
| Number of attempts to successfully insertion | Day 8 | Note Number of attempts to successfully insert as 1,2,3 attempts |
| Dry Eye | Day 8, Day 14, and Day 37. | SPEED Survey Lower score indicates less dryness which is better than a higher score |
| Central Macular Thickness | Baseline to Day 37 | Mean change of Central Macular Thickness by Optical coherence tomography |
| Insert Retention | Day 8 to 37 days | By slit lamp exam if insert is visualized or not |
| Ease of insertion | Day 8 | Noted as Easy, Moderate, or Difficult |
Countries
United States
Outcome results
None listed