L. Mastropasqua et al., DELAYED POSTOPERATIVE USE OF 5-FLUOROURACIL AS AN ADJUNCT IN MEDICALLY UNCONTROLLED OPEN-ANGLE GLAUCOMA, Eye, 12, 1998, pp. 701-706
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.