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dc.contributor.authorNarayanaswamy, Arun Kumaren
dc.contributor.authorLee, Kelvinen
dc.contributor.authorZhen, Maen
dc.contributor.authorChua, Jocelynen
dc.contributor.authorChai, Shu Mingen
dc.contributor.authorBoey, Pui Yien
dc.contributor.authorZheng, Ceen
dc.contributor.authorAung, Tinen
dc.contributor.authorVenkatraman, Subramanianen
dc.contributor.authorWong, Tina Tzee Lingen
dc.identifier.citationNarayanaswamy, A. K., Lee, K., Zhen, M., Chua, J., Chai, S. M., Boey, P. Y., et al. (2012). Randomized, controlled trial of a sustained delivery formulation of 5-Fluorouracil for the treatment of failing blebs. Ophthalmology, 119(2), 314-320.en
dc.description.abstractPurpose: To determine the efficacy of a subconjunctival injection of hyaluronic acid (HA) with 5-fluorouracil (5FU) formulation as an adjunct in reviving bleb function by needling. Design: Prospective, randomized, controlled trial. Participants: Fifty patients with previous trabeculectomy and scheduled by the managing physician for a needling intervention. Methods: One eye of each patient was randomized to receive needling with HA-5FU mixture or needling with subconjunctival injection of 5FU solution alone. Main Outcome Measures: The primary outcome was the percentage of subjects with an intraocular pressure (IOP) <15 mmHg without any medications at 3 months. Secondary outcomes included the need for additional needling procedures and changes in bleb morphology. Results: Forty-nine subjects (25 in the HA-5FU group and 24 in the 5FU group) completed 3 months of follow-up. At baseline, there was no significant difference between the groups in terms of demographic features, subtype of glaucoma, vertical cup-to-disc ratio, or visual field indices. The mean number of glaucoma medications at baseline was higher in the 5FU group (0.8±1.1 [mean ± standard deviation] vs. 0.2±0.6, P = 0.04). An IOP <15 mmHg without medications was reached in 48.0% of subjects in the HA-5FU group and in 33.3% of subjects in the 5FU group (P = 0.2). At 3 months, both groups demonstrated a significant decrease in IOP from baseline (HA-5FU: decrease of 5.9 mmHg [95% confidence interval, 3.4–8.4]; 5FU: decrease of 6.0 mmHg [95% confidence interval, 3.2–8.2]; P<0.001 for both). Intergroup comparisons for IOP change from baseline was not significant (P = 0.9). However, repeat needling was required more frequently in the 5FU group compared with the HA-5FU group (50.0% vs. 12.0%; P = 0.004). There were no significant differences in the number of reported adverse events, bleb vascularity, or morphology between the 2 groups. Conclusions: Subconjunctival injection of HA-5FU to revive bleb function after bleb needling is as effective as 5FU solution. Fewer repeat needlings were required after treatment with HA-5FU, suggesting that the use of a combined formulation of HA-5FU may improve the overall outcomes of bleb needlings. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.en
dc.titleRandomized, controlled trial of a sustained delivery formulation of 5-Fluorouracil for the treatment of failing blebsen
dc.typeJournal Articleen
dc.contributor.schoolSchool of Materials Science & Engineeringen
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