DELAYED POSTOPERATIVE USE OF 5-FLUOROURACIL AS AN ADJUNCT IN MEDICALLY UNCONTROLLED OPEN-ANGLE GLAUCOMA

Purpose The current study was performed to evaluate the efficacy and s afety of late postoperative use of subconjunctival 5-fluorouracil (5-F U) with ocular massage (OM) after trabeculectomy with or without intra operative mitomycin C (MMC) in patients with medically uncontrolled pr imary open angle glaucoma (POAG). Methods Initial trabeculectomy was p erformed in 60 eyes of 60 consecutive patients with medically uncontro lled POAG. Thirty eyes (group 1) were randomly assigned to intraoperat ive MMC (0.2 mg/ml for 3 min) and 30 (group 2) were randomised to stan dard trabeculectomy. During the first 3 months post-operatively OM and subconjunctival injections of 5-FU (5 mg in 0.5 mi of balanced salt s olution) were performed in both groups every time the clinical evaluat ion suggested imminent bleb failure. Suture lysis was not performed in any patient. Results Follow-up ranged from 14 to 53 months (mean 30.1 7, SD 9.23) in trabeculectomy + MMC treated eyes and from 6 to 54 mont hs (mean 27.37, SD 10.83) in trabeculectomy treated eyes. During the f irst 3 months of follow-up OM and subconjunctival injections of 5-FU w ere performed in 14 cases in group 1 and in 18 cases in group 2 (p = N S). A positive response to OM was obtained in 14 of 14 eyes and in 14 of 18 eyes in group 1 and in group 2, respectively (p = 0.042). The di fference in postoperative mean IOP between the two groups was statisti cally significant at each time interval studied (p <0.001). Success (c omplete or qualified) was achieved in 50 of 60 eyes (83.33%): 28 (93.3 %) in the trabeculectomy + MMC treated group and 22 (73.3%) in the tra beculectomy treated group (p = 0.039). Among the complications seen, t he incidence of bleb fibrosis was higher in group 2 (p = 0.0026). By m eans of post-operative treatment four non-randomised subgroups were id entified: intraoperative MMC + post-operative 5-FU, intraoperative MMC + no post-operative 5-FU, no intraoperative MMC + post-operative 5-FU , no intraoperative MMC + no post-operative 5-FU. The eyes treated wit h intraoperative MMC and post-operative 5-FU had a better long-term (4 8 months) cumulative probability of success (100%); treatment with int raoperative MMC or post-operative 5-FU alone was followed by a success rate of 87.1% and 72.2%, respectively. The cumulative probability of success after only trabeculectomy was 56% (p < 0.05). One case of hypo tony maculopathy was found in the subgroup treated only with intraoper ative MMC. Conclusions This study confirms the effectiveness and relat ive safety of delayed post-operative 5-FU treatment in patients with c linical evidence of bleb failure. Only when OM had caused a lowering o f IOP were late subconjunctival injections of 5-FU followed by good co ntrol of IOP. The use of intraoperative MMC may ensure a greater IOP d ecrease after OM.