Could a tiny eye insert replace drops for kids after surgery?
NCT ID NCT05620901
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early study tested a tiny dexamethasone insert placed in the tear duct of 15 children after retinal surgery or laser treatment. The goal was to see if it could safely reduce pain and eye inflammation. Researchers measured pain using a standard scale and tracked any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dexamethasone eye insert (DEXTENZA)
- What this could lead to
- If it works, this could offer a simpler way to manage pain and swelling in children after eye surgery, possibly reducing the need for eye drops.
- What could go wrong
- This is a very early, small study with only 15 children, so results may not apply to all kids. The insert may cause side effects or not work better than standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
15 people
The number who actually took part.
- Started
-
Feb 2023
- Finished
-
Feb 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
3 to 17 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Pediatric patients undergoing routine retinal surgery or laser treatment under anesthesia for a variety of visual conditions. These conditions and procedures include but are not limited to: Conditions: * Familial Exudative Vitreoretinopathy * Coats' Disease * Exudative Retinopathy * Lattice degeneration * Retinal holes * Sickler's syndrome * Retinal detachment, rhegmatogenous * Retinal detachment, exudative * Retinal detachment, tractional Procedures * Laser photocoagulation * Cryotherapy * Retinal detachment repair with scleral buckle and cryotherapy * Retinal detachment repair with vitrectomy * Written informed consent from parent/legal guardian Exclusion Criteria: Preprocedural * Active or history of chronic or recurrent inflammatory eye disease in either eye * Any patient of reproductive potential that has a positive pregnancy test during pre-procedural testing * Active or history of increased ocular pressure * Patients with active corneal, conjunctival, and canalicular infections * Patients with punctal stenosis or other punctal anatomical abnormalities that would not be conducive with device insertion * Nasolacrimal duct obstruction * Laser or incisional ocular surgery during the study period and 6 months prior in the study eye * current use of systemic or topical steroids or NSAIDS on a regular basis * History of autoimmune disease that may interfere with treatment/outcomes * Ocular pain at the time of screening * Known malignancy * Current use of cyclosporin or a TNF blocker * Ocular hypertension IOP \>25, actively taking medications for ocular hypertension, any history of IOP spikes in either including steroid associated IOP elevation * Congenital ocular lid and tear duct system abnormalities (e.g. congenital ectropion/entropion, trichiasis) * Evidence of acute external ocular infection of the study eye * Active or history of HSV * Previous trauma causing deformity * Previous enrollment or current enrollment with another clinical trial within the last 30 days that may interfere with treatment * Known allergies to product under investigation * Inability to engage in VA testing * Investigator determines that the candidate is not eligible for participation based on clinical or historical factors that would interfere with treatment or impact patient safety not specified above * Current artificial tear use \>4x daily * Current use of any topical ocular drops * Anyone who, in the opinion of the investigator, would not be a good candidate for the study. Intraoperatively * Multiple procedures required * Complication occurs that surgeon determines makes the patient ineligible for study inclusion * Unsuccessful dilation of the punctum to 0.7mm when dilation attempted * during the exam under anesthesia, if it is decided that periocular Kenalog injection is indicated this patient fails screen and will no longer be eligible for the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Duke Eye Center
Durham, North Carolina, 27710, United States
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Other studies related to the condition(s) this trial covers.
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