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Title: | Randomized, controlled trial of a sustained delivery formulation of 5-Fluorouracil for the treatment of failing blebs | Authors: | Narayanaswamy, Arun Kumar Lee, Kelvin Zhen, Ma Chua, Jocelyn Chai, Shu Ming Boey, Pui Yi Zheng, Ce Aung, Tin Venkatraman, Subramanian Wong, Tina Tzee Ling |
Keywords: | DRNTU::Engineering::Materials::Biomaterials | Issue Date: | 2012 | Source: | Narayanaswamy, 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. | Series/Report no.: | Ophthalmology | Abstract: | Purpose: 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. | URI: | https://hdl.handle.net/10356/98884 http://hdl.handle.net/10220/17114 |
ISSN: | 0161-6420 | DOI: | 10.1016/j.ophtha.2011.07.053 | Schools: | School of Materials Science & Engineering | Fulltext Permission: | none | Fulltext Availability: | No Fulltext |
Appears in Collections: | MSE Journal Articles |
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