Tiny steroid implant may boost glaucoma surgery success
NCT ID NCT04918121
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tests whether placing a slow-release steroid insert (Yutiq) during glaucoma drainage surgery helps reduce scarring and keeps eye pressure lower. About 5 adults with glaucoma will receive the implant along with their surgery. Researchers will compare their pressure and medication needs to similar patients who had surgery without the insert.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 5 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2021
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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: 1. At least 18 years old at time of consent. 2. Patient being consented for either glaucoma tube implant surgery in pseudophakic eyes or being consented for cataract surgery with glaucoma tube implant surgery. 3. Diagnosis of any type of glaucoma except inflammation associated glaucomas such as with co-existing uveitis or neovascular glaucoma. 4. Negative urine pregnancy test at baseline for women of childbearing potential. 5. Subjects who are willing and able to comply with scheduled visits, treatment plan and other study procedures and are able to provide an informed consent document signed and dated by the subject Exclusion Criteria: 1. Allergy to corticosteroids or any component of Yutiq insert. 2. Patients with active or suspected ocular or periocular infections including most viral diseases such as herpes simplex, vaccinia, varicella, mycobacterial infections and fungal diseases. 3. History of systemic immunosuppressive therapy or the possible need thereof such as patients with rheumatoid arthritis, lupus or transplant (systemic or eye) 4. Previous history of tube erosion in the same or the other eye 5. Eyes receiving anti-VEGF therapy in the study eye 6. Media opacity precluding evaluation of retina and optic nerve in the study eye. 7. History of steroid induced glaucoma 8. Ocular surgery in the study eye within 3 months prior to enrollment. 9. Patients who have tested positive for human immune deficiency virus. 10. Pregnant or lactating females or females of child bearing age who are not willing to use contraception for the duration of the study. 11. Patients for whom any of the protocol procedures may pose a special risk not outweighed by the potential benefits of participating in the study. 12. Patients who are unlikely to comply with the study protocol. 13. Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the patient inappropriate for entry into this study. 14. Treatment with an investigational drug or device within 30 days preceding the glaucoma surgery. 15. Any eye needing urgent glaucoma surgery i.e. within 5 days of the baseline visit (to allow time for patients to review the study documents).
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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
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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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