← Back to Search

Dexamethasone Insert vs Steroid Drops for Postoperative Inflammation

Phase 4
Waitlist Available
Led By Rishi Singh, M.D.
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planning to undergo vitreoretinal surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 3, 7, 14, and 21 following surgery
Awards & highlights

Study Summary

This trial will compare the efficacy of two treatments for inflammation following vitreoretinal surgery. One group will receive a dexamethasone insert and the other group will receive topical steroid drops.

Who is the study for?
Adults over 18 needing vitreoretinal surgery for macular hole, epiretinal membrane removal, or vitreomacular traction can join. Excluded are those with certain eye conditions, recent other surgeries or clinical trial participation, ongoing narcotic use, uncontrolled diseases like diabetes, known drug allergies, pregnancy/nursing status or specific glaucoma history.Check my eligibility
What is being tested?
The study compares two treatments post-vitreoretinal surgery: an intracanalicular dexamethasone insert versus topical steroid drops. It aims to assess inflammation control on days 1, 7, 14 and 21 after the procedure in a randomized setup.See study design
What are the potential side effects?
Potential side effects include discomfort at the insertion site for Dextenza (dexamethasone insert), increased eye pressure which could lead to glaucoma if not monitored and managed properly; Prednisolone may cause burning/stinging upon application and potential increase in intraocular pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for eye surgery to fix a macular hole, remove an epiretinal membrane, or address vitreomacular traction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 3, 7, 14, and 21 following surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 3, 7, 14, and 21 following surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To assess control of inflammation following the vitreoretinal surgical procedure.
Secondary outcome measures
% of patients receiving rescue treatment.
% of patients with postoperative management via telephone or electronic messaging
% of patients with rebound inflammation defined as a two-step worsening of inflammation by SUN grading.
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intracanalicular dexamethasone insert groupExperimental Treatment1 Intervention
This arm will receive the DEXTENZA® insert within minutes after the completion of the surgery.
Group II: Topical steroid drop groupActive Control1 Intervention
This arm will receive the prescription for daily prednisolone acetate 1% eye drops 4 times a day for the first week following the procedure, starting on the day of surgery.

Find a Location

Who is running the clinical trial?

Ocular Therapeutix, Inc.Industry Sponsor
53 Previous Clinical Trials
5,547 Total Patients Enrolled
10 Trials studying Inflammation
1,205 Patients Enrolled for Inflammation
The Cleveland ClinicLead Sponsor
1,026 Previous Clinical Trials
1,366,046 Total Patients Enrolled
7 Trials studying Inflammation
1,760 Patients Enrolled for Inflammation
Rishi Singh, M.D.Principal InvestigatorCole Eye Institute, Cleveland Clinic
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Dexamethasone Ophthalmic Insert Clinical Trial Eligibility Overview. Trial Name: NCT04371445 — Phase 4
Inflammation Research Study Groups: Topical steroid drop group, Intracanalicular dexamethasone insert group
Inflammation Clinical Trial 2023: Dexamethasone Ophthalmic Insert Highlights & Side Effects. Trial Name: NCT04371445 — Phase 4
Dexamethasone Ophthalmic Insert 2023 Treatment Timeline for Medical Study. Trial Name: NCT04371445 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA accepted Dexamethasone Ophthalmic Insert as a legitimate medication?

"There is ample evidence supporting the safety of Dexamethasone Ophthalmic Insert, so this treatment receives a score of 3. This drug has been approved by relevant authorities after numerous successful trials in phase 4."

Answered by AI

What is the participant count of this clinical trial?

"Unfortunately, this clinical trial has ceased its search for participants. Initially advertised on December 1st 2020 and last updated February 24th 2022, individuals interested in similar studies may refer to 837 different trials involving vitreoretinal surgery or 556 that involve Dexamethasone Ophthalmic Inserts."

Answered by AI

Are there any open recruitment slots available for this scientific experiment?

"According to clinicaltrials.gov, the initial listing for this trial was posted on December 1st 2020 and has not been updated since February 24th 2022. Therefore, it is not presently enrolling participants; however, there are 1393 other medical studies seeking patients at the current moment in time."

Answered by AI

Has Dexamethasone Ophthalmic Insert been examined in any prior experiments?

"Presently, there are 556 active studies involving Dexamethasone Ophthalmic Insert with 145 trials in the third phase. Most of these investigations take place in Mishawaka, Indiana; however, research is being conducted at 18,626 different sites worldwide."

Answered by AI

What medical conditions can be alleviated with the administration of Dexamethasone Ophthalmic Insert?

"Dexamethasone Ophthalmic Insert is typically used to manage ophthalmia, sympathetic. It has also been found helpful in treating branch retinal vein occlusion, bacterial eye infections and macular edema."

Answered by AI
Recent research and studies
~7 spots leftby Apr 2025