NCT04479748

DEXTENZA Compared to Topical Steroid Therapy Prior to Cataract Surgery in Patients Who Receive Premium Intraocular Lenses

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Prism Vision Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators seek to assess the effect of pre-operative and continued post-operative corticosteroid use on pain, patient preference, visual outcomes, and change in objective quantifiable biological parameters in patients undergoing bilateral cataract surgery with premium intraocular lens implantation with or without baseline ocular surface disease. Patient's first eye scheduled for surgery will receive an intracanalicular insertion of DEXTENZA (dexamethasone release profile of QID, TID, BID, QD, over 30 days; study eye). The fellow-eye will receive topical prednisolone acetate 1% (tapering schedule of QID, TID, BID, QD over 30 days). The fellow-eye design in n=30 patients (60 eyes) allows for balance in patient baseline demographic and systemic characteristics.

Conditions

• Cataract

Interventions

Type	Name	Description
DRUG	Dexamethasone	Treatment of pain and inflammation following ophthalmic surgery
DRUG	Prednisolone Acetate 1% Oph Susp	Topical steroid

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-12-12
• Completion: 2022-12-12
• First posted: 2020-07-21
• Last updated: 2023-06-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study