NCT05665270

A Study for Post op Inflammation After Cataract Surgery

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Wyse Eyecare · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cataract

Interventions

Type	Name	Description
DRUG	Dextenza 0.4Mg Ophthalmic Insert	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.
DRUG	Prednisolone Acetate 1%	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.

Timeline

• Start date: 2023-01-30
• Primary completion: 2023-10-31
• Completion: 2023-12-15
• First posted: 2022-12-27
• Last updated: 2023-04-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study