title: Randomized, controlled trial of a sustained delivery formulation of 5-fluorouracil for the treatment of failing blebs.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Prospective, randomized, controlled trial.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
authors.affiliation: Singapore Eye Research Institute, Singapore.
authors.forename: Arun Kumar
authors.initials: AK
authors.lastname: Narayanaswamy
authors.forename: Kelvin
authors.initials: K
authors.lastname: Lee
authors.forename: Ma
authors.initials: M
authors.lastname: Zhen
authors.forename: Jocelyn
authors.initials: J
authors.lastname: Chua
authors.forename: Shu Ming
authors.initials: SM
authors.lastname: Chai
authors.forename: Pui Yi
authors.initials: PY
authors.lastname: Boey
authors.forename: Ce
authors.initials: C
authors.lastname: Zheng
authors.forename: Tin
authors.initials: T
authors.lastname: Aung
authors.forename: Subramanian
authors.initials: S
authors.lastname: Venkatraman
authors.forename: Tina Tzee Ling
authors.initials: TT
authors.lastname: Wong
mesh_terms: D000368:Aged; D001082:Aqueous Humor / Q000378:metabolism; D003228:Conjunctiva / Q000187:drug effects*; D003692:Delayed-Action Preparations; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; D005901:Glaucoma / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D007429:Intraocular Pressure / Q000502:physiology; D008297:Male; D009339:Needles; D010030:Ostomy / Q000379:methods*; D011446:Prospective Studies; D041623:Tomography, Optical Coherence; D014065:Tonometry, Ocular; D014130:Trabeculectomy; D017211:Treatment Failure
chemical_list: D003692:Delayed-Action Preparations; D006820:Hyaluronic Acid; D005472:Fluorouracil