drugset / Trial / NCT04479748

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

NCT04479748

Phase 4 Completed 13 enrolled Prism Vision Group
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-10-01
Primary completion
2022-12-12
Completion
2022-12-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule Other
Subject Prednisolone Other / unclassified 1 % Topical

Indications