Steroid Treatment for Cataracts

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Wyse Eyecare

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults over 18 who are having cataract surgery and have certain eye conditions like epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration. They must be able to follow the study plan and give consent. People with complete punctal occlusion, active infections, on immunomodulating drugs or steroids, pregnant or nursing women, or those with a history of herpes in the eyes cannot join.

Treatment Details

The study tests if adding a dexamethasone insert (Dextenza) to regular steroid eye drops after cataract surgery can reduce inflammation better in patients with specific eye conditions. It's randomized: some get this new treatment while others don't; it's controlled by comparing these groups.

2Treatment groups

Experimental Treatment

Active Control

Group I: DextenzaExperimental Treatment1 Intervention

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 II: Prednisolone AcetateActive Control1 Intervention

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.