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Ophthalmic Insert

Dextenza for Post-Retinal Surgery Care in Children

Phase < 1
Recruiting
Led By Lejla Vajzovic, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pediatric patients undergoing routine retinal surgery or laser treatment under anesthesia for a variety of visual conditions including but not limited to Familial Exudative Vitreoretinopathy, Coats' Disease, Exudative Retinopathy, Lattice degeneration, Retinal holes, Sickler's syndrome, Retinal detachment (rhegmatogenous, exudative, tractional), and procedures such as Laser photocoagulation, Cryotherapy, Retinal detachment repair with scleral buckle and cryotherapy, Retinal detachment repair with vitrectomy
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 45 post-op
Awards & highlights

Study Summary

This trial investigates the safety and effectiveness of a medical insert in children who have had eye surgery or laser treatment while under anesthesia.

Who is the study for?
This trial is for children needing retinal surgery or laser treatment under anesthesia. They must have conditions like Retinal Detachment, Lattice Degeneration, and others. Kids can't join if they have eye inflammation history, are pregnant, have increased eye pressure, infections, recent surgeries, use certain drugs or steroids, autoimmune diseases, ocular pain at screening time.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of DEXTENZA insert versus Pred Forte in kids after retinal procedures. It's an open-label trial where participants know which treatment they receive; it's also randomized to compare outcomes fairly between the two treatments.See study design
What are the potential side effects?
Possible side effects include increased eye pressure from DEXTENZA or Pred Forte usage. There may be risks of infection or allergic reactions to the medications used in this pediatric population.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child is having eye surgery for a serious vision condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 45 post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 45 post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Analgesics
Secondary outcome measures
Caregivers Treatment Adherence
Cell Count
Incidence of adverse events
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment ArmExperimental Treatment1 Intervention
Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
Group II: Control ArmActive Control1 Intervention
Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QUID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28.
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?

Duke UniversityLead Sponsor
2,356 Previous Clinical Trials
3,419,095 Total Patients Enrolled
2 Trials studying Retinal Detachment
30,262 Patients Enrolled for Retinal Detachment
Lejla Vajzovic, MDPrincipal InvestigatorDuke Eye Center
1 Previous Clinical Trials
88 Total Patients Enrolled

Media Library

Dextenza 0.4Mg Ophthalmic Insert (Ophthalmic Insert) Clinical Trial Eligibility Overview. Trial Name: NCT05620901 — Phase < 1
Retinal Detachment Research Study Groups: Treatment Arm, Control Arm
Retinal Detachment Clinical Trial 2023: Dextenza 0.4Mg Ophthalmic Insert Highlights & Side Effects. Trial Name: NCT05620901 — Phase < 1
Dextenza 0.4Mg Ophthalmic Insert (Ophthalmic Insert) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05620901 — Phase < 1

Frequently Asked Questions

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

Are they accepting participants below the age of fifty-five for this trial?

"For this research, our team is recruiting participants between the ages of three and seventeen."

Answered by AI

Who is eligible to take part in this experiment?

"This medical study seeks 30 participants aged between 3 and 17 that suffer from retinal telangiectasis. To be eligible, applicants must demonstrate Familial Exudative Vitreoretinopathy, Exudative Retinopathy, Lattice degeneration, Retinal holes, Sickler's syndrome, Retinal detachment (rhegmatogenous or exudative/tractional), Procedures or Coats' Disease."

Answered by AI

Are there vacancies for participants in this test?

"According to information facilitated by clinicaltrials.gov, this research study is not currently enrolling participants. This trial was initially posted on November 1st 2022 and last edited on the 10th of that same month. Despite this, there are 41 other studies recruiting patients at the moment."

Answered by AI
~0 spots leftby Apr 2024