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Corticosteroid

Steroid Treatment for Cataracts

Phase 4
Waitlist Available
Research Sponsored by Wyse Eyecare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 8, 14, 37
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial looks at the safety and effectiveness of a steroid treatment for eye problems after cataract surgery.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include increased pressure inside the eye which could lead to glaucoma, delayed healing of the eye surface after surgery, secondary infection within the eye from bacteria/fungi/viruses introduced during surgery or postoperative period.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 8, 14, 37
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 8, 14, 37 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Absence of anterior chamber cells
Secondary study objectives
BCVA
Central Macular Thickness
Dry Eye
+9 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dextenza 0.4Mg Ophthalmic Insert
2020
Completed Phase 4
~210

Find a Location

Who is running the clinical trial?

Wyse EyecareLead Sponsor

Media Library

Prednisolone Acetate (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05665270 — Phase 4
Cataract Research Study Groups: Dextenza, Prednisolone Acetate
Cataract Clinical Trial 2023: Prednisolone Acetate Highlights & Side Effects. Trial Name: NCT05665270 — Phase 4
Prednisolone Acetate (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05665270 — Phase 4
~15 spots leftby Nov 2025
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