Dextenza Insert for Post-Cataract Surgery Inflammation

Recruiting in Palo Alto (17 mi)

Overseen byNicole Fram, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Nicole Fram M.D.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

Eligibility Criteria

This trial is for adults with significant cataracts scheduled for Clear Cornea Incision Cataract Extraction. Participants must be able to consent and follow the study plan. Excluded are those under 18, pregnant, known steroid responders, have poor visual potential or active infections, use immunosuppressants or oral steroids, have a history of certain eye conditions or surgeries.

Inclusion Criteria

Are willing and able to comply with clinic visits and study related procedures

Are willing and able to sign the informed consent form

I am diagnosed with a significant cataract and plan to have surgery.

Exclusion Criteria

I am currently receiving treatment with a corticosteroid implant.

Pregnant or planning to become pregnant during the trial period

I do not have an active infectious disease.

+15 more

Participant Groups

The trial tests DEXTENZA (a dexamethasone insert) against standard treatments like Prednisolone Acetate and Prolensa drops after cataract surgery. It aims to see if DEXTENZA can better reduce inflammation and pain while improving visual outcomes post-surgery.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimenExperimental Treatment2 Interventions

Following cataract surgery with DEXTENZA 0.4mg insert, patients will receive: Prolensa 0.07% QD X 4 Weeks and stop

Group II: Arm 1 - Cataract surgery gtt regimen per SOCActive Control2 Interventions

Following cataract surgery (without Dextenza 0.4mg insert) patients will receive: Prednisolone Acetate 1% QID X 2 Weeks, then BID x 2 weeks and stop / Prolensa 0.07% QD X 4 Weeks and stop.