Imaging of Uveitis Patients Receiving Injectable Fluocinolone Acetonide Implant
Completed
Conditions studied: Uveitis
In brief
We will prospectively observe patients with uveitis who are either active or were recently active in the previous 6 months and are treated with the i-FA implant. All of the patients will have standard clinical exams at baseline and image quantification of their inflammation using OCT, OCTA and UWFFA (if needed). At baseline, ETDRS vision will be measured. Patients will be followed for 12 months months. During follow-up repeat imaging will be performed along with standard examinations, visual acuity and contrast sensitivity measurements. At the final visit, all tests will be repeated. Data collected will be analyzed using statistical software package. Correlations between changes in imaging quantification of inflammation scores and changes in visual acuity, clinical grades of inflammation, and contract sensitivity will be calculated.
Key facts
- Study ID
- NCT04340505
- Run by
- The Cleveland Clinic
- People needed
- 30
- Starts
- 2019-08-08
- Expected to finish
- 2026-02-01
- Last updated by the study team
- 2026-02-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 1. Any patient with a diagnosis of uveitis, who is deemed active or recently active (6 months) by a uveitis specialist and requires an injectable fluocinolone acetonide implant to treat their inflammation.
You may not qualify if…
- 1. Poor view in fundus in both eyes which precludes image acquisition in those with posterior uveitis 2. Those with any allergy to fluorescein 3. Corneal opacities which prevent image acquisition 4. Inability to sign consent 5. Poor candidates for injectable fluocinolone acetonide (advanced glaucoma without previous filtering surgery, chronic elevated IOP (>25) on maximal topical anti-glaucoma drops and evidence of optic nerve progression.
- Children under the age of 18 and pregnant/nursing mothers.
Where it is running
- Cole Eye Institute Cleveland Clinic Foundation — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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