A Phase 4 interventional study of Dextenza 0.4Mg Ophthalmic Insert and Prednisolone Acetate 1% in Cataract, sponsored by Wyse Eyecare. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-26.
Sponsored by Wyse Eyecare · Phase 4, Interventional, and Treatment
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.
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →This is the only study on the registry with Wyse Eyecare as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Subjects will be eligible for study participation if they:
Exclusion Criteria:
Subjects are not eligible for study participation if they:
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
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%
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.
Absence of anterior chamber cells
SUN Scale (0 minimum/better to 4 maximum/ worse)
Time frame: at Day 14
BCVA
Snellen Chart
Time frame: Baseline (day 8) to day 37
Number of subjects requiring rescue steroid
Addition of steroid treatment
Time frame: Day 8 to Day 37
Number and Percentage of subjects with complete absence of cell
SUN Scale
Time frame: Day 8 to 37
Measuring Cell
Sun Scale (0 minimum/better to 4 maximum/ worse)
Time frame: Day 8, 14, 37
Measuring Flare
Sun Scale (0 minimum/better to 4 maximum/ worse)
Time frame: Day 8, 14, 37
Eye Pain
VAS Questionnaire 0 no pain to 10 worst possible pain
Time frame: Day 8, 14, 37
Ease of insertion
Noted as Easy, Moderate, or Difficult
Time frame: Day 8
Ease of Visualization
Noted as Easy, Moderate, or Difficult
Time frame: Day 8, 14, 37
Number of attempts to successfully insertion
Note Number of attempts to successfully insert as 1,2,3 attempts
Time frame: Day 8
Dry Eye
SPEED Survey Lower score indicates less dryness which is better than a higher score
Time frame: Day 8, Day 14, and Day 37.
Central Macular Thickness
Mean change of Central Macular Thickness by Optical coherence tomography
Time frame: Baseline to Day 37
Insert Retention
By slit lamp exam if insert is visualized or not
Time frame: Day 8 to 37 days
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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