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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 8, 14, 37
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 8, 14, 37
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absence of anterior chamber cells
Secondary outcome measures
BCVA
Central Macular Thickness
Dry Eye
+9 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had both tear ducts blocked in the past.You cannot participate if you have a current infectious disease throughout your whole body.You have a blocked tear duct in the eye being studied.You are allergic to dexamethasone or your body reacts strongly to steroid medication.You have a history of swelling or inflammation in your eyes.You are currently receiving a corticosteroid implant called Ozurdex.
Research Study Groups:
This trial has the following groups:- Group 1: Dextenza
- Group 2: Prednisolone Acetate
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Group Dextenxa earned regulatory approval from the FDA?
"Our team at Power has determined that due to its Phase 4 trial status, the safety of Group Dextenxa is highly assured and thus rated it a 3."
Answered by AI
Is this research project currently recruiting participants?
"The clinicaltrials.gov database confirms that this specific medical trial, which was initially posted on May 1st 2023 and last updated in December 15th 2022, is not actively recruiting participants at the moment. Nevertheless, 126 other trials are currently seeking out volunteers for their studies."
Answered by AI
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