Abstract | PURPOSE: DESIGN: Noncomparative interventional case series, dose randomized, dose masked, prospective. PARTICIPANTS: Thirty-six eyes of 32 patients with a history of recurrent noninfectious posterior uveitis. METHODS: Patients were randomized to receive either a 0.59-mg or a 2.1-mg fluocinolone acetonide intravitreal implant. Patients were observed every 4 to 6 weeks for the first 3 months and then every 3 months thereafter. MAIN OUTCOME MEASURES: Preoperative and postoperative ocular inflammation, visual acuity (VA), antiinflammatory medication use, and safety. RESULTS: Mean follow-up duration was 683+/-461 days (range, 204-1817). Mean baseline visual acuity for the device-implanted eyes was +1.1 logarithm of the minimum angle of resolution (logMAR) units (20/250), which improved significantly to +0.81 logMAR units (20/125) at 30 months (P<0.05). Inflammation was effectively controlled over the follow-up period. The average number of recurrences in the 12 months before implantation was 2.5 episodes per eye. None of these eyes experienced a recurrence for the first 2 years after implantation. There was a reduction in systemic and local therapy use in the device-implanted eyes; of the patients who remained on systemic medication after implantation, dosage was reduced in 68%. The posterior sub-Tenon's capsule injection rate significantly decreased from a mean of 2.2 injections per eye per year to 0.07 injections per eye per year (P<0.0001) The most common adverse event was intraocular pressure (IOP) rise. At baseline, 11.0% of eyes used pressure-lowering agents, versus 56.1% over the follow-up period (P = 0.005). Filtering procedures were performed in 7 (19.4%) eyes. Four of the 8 phakic eyes, each of which had some level of cataract at device implantation, subsequently underwent cataract extraction. There were no device explantations or patients lost to follow-up during the investigation. CONCLUSION:
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Authors | Glenn J Jaffe, Rex M McCallum, Brenda Branchaud, Cindy Skalak, Zuhal Butuner, Paul Ashton |
Journal | Ophthalmology
(Ophthalmology)
Vol. 112
Issue 7
Pg. 1192-8
(Jul 2005)
ISSN: 1549-4713 [Electronic] United States |
PMID | 15921758
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Drug Implants
- Glucocorticoids
- Fluocinolone Acetonide
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Topics |
- Adolescent
- Adult
- Aged
- Cataract
(chemically induced)
- Double-Blind Method
- Drug Implants
- Female
- Fluocinolone Acetonide
(administration & dosage, adverse effects)
- Follow-Up Studies
- Glucocorticoids
(administration & dosage, adverse effects)
- Humans
- Intraocular Pressure
(drug effects)
- Male
- Middle Aged
- Pilot Projects
- Prospective Studies
- Safety
- Treatment Outcome
- Uveitis, Posterior
(drug therapy)
- Visual Acuity
- Vitreous Body
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