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Docetaxel and mitomycin as second-line treatment in advanced non-small cell lung cancer.

PURPOSE: To evaluate the feasibility, toxicity and efficacy of the combination of docetaxel and mitomycin C as second-line chemotherapy in patients with advanced non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: Thirty-eight patients with histologically confirmed, locally advanced or metastatic NSCLC were included in this phase II trial. All patients had been previously treated with a platinum-based regimen. Treatment consisted of docetaxel (75 mg/m2) followed by mitomycin C (8 mg/m2) on day 1, every 21 days. Patients received a minimum of three courses unless progressive disease was detected. RESULTS: A total of 190 courses of docetaxel-mitomycin C were administered (median five courses per patient). This combination was well tolerated with grade 3-4 toxicity experienced with the following frequency: neutropenia in five patients (13%), fatigue in four (11%), anaemia, thrombocytopenia, nausea/vomiting and peripheral neuropathy in one each (3%). Three of 38 patients had a partial response (8%, 95% confidence interval 2.6-21.6%), 14 patients (37%) experienced stabilization of disease and 21 (55%) had disease progression. Median time to progression was 3.6 months. Overall median survival was 10.4 months, with the 1-year actuarial survival rate being 35%. CONCLUSIONS: The addition of mitomycin C to docetaxel as second-line therapy in NSCLC is well tolerated but does not seem to improve the response rate.

Adult↗

Five-year results of trabeculectomy with mitomycin C.

BACKGROUND: The long-term efficacy and safety of primary trabeculectomy with mitomycin C were retrospectively studied. METHODS: Sixty eyes of 60 patients with severe glaucoma, 25 female and 35 male, with a mean age of 72.5 years who underwent primary trabeculectomy with mitomycin C between 1993 and 1995 were included. Glaucoma subtypes consisted of 42 patients with primary open-angle glaucoma, 10 patients with normal-pressure glaucoma, 2 patients with chronic narrow-angle glaucoma, 5 patients with pigment dispersion syndrome and 1 patient with pseudoexfoliation syndrome. During surgery, mitomycin C 0.2 mg/ml was applied under the scleral flap for 3 min. RESULTS: Mean intraocular pressure (IOP) decreased from 22.3+/-9.3 preoperatively to 12.6+/-3.5 mmHg postoperatively. With success defined as an IOP level of 15 mmHg or less, a success rate of 83.3% was obtained in the 1st year, dropping to 60% in the 6th year following trabeculectomy. Visual fields remained stable in 73.3% of cases during the follow-up period. LogMAR visual acuity increased from 0.2 to 0.4. Four eyes underwent cataract surgery prior to trabeculectomy. Thirteen eyes underwent cataract surgery during the follow-up period. Long-term complications were relatively mild and consisted of two cases of blebitis. Bleb reconstruction was performed in five eyes with overfiltration or bleb-related complaints. CONCLUSIONS: The present findings indicate that the additional use of mitomycin C may be justified in trabeculectomies in patients with severe glaucoma.

Aged↗

Specific features of apoptosis in human lens epithelial cells induced by mitomycin C in vitro.

BACKGROUND: Posterior capsule opacification (PCO) is still one of the major complications following modern cataract surgery. Several attempts have been made to find an appropriate therapeutic concept to significantly lower the rate of PCO. Here, we wanted to focus on the antimetabolic strategy, reducing PCO by using mitomycin C, further characterizing the pathway of apoptosis in human lens epithelial cells (hLECs). METHODS: Human lens epithelial cells were obtained from anterior lens capsules during cataract surgery. The expression of Fas, TRAMP, TRAIL-R1-R4, Apo-3L and TRAIL mRNA was investigated by means of RT-PCR using specific primers. For investigations on bcl-2, bax, p53 and the active form of caspase 3, cell cultures of hLECs were pretreated with mitomycin C and processed for immunocytochemistry thereafter. RESULTS: We detected the expression of the receptors Fas, TRAMP, TRAIL-R2 and TRAIL-R3 in hLECs. We further obtained evidence of the upregulation of the intracellular apoptotic signalling cascade, represented by bcl-2 and bax, the transcription factor p53 and the active form of caspase 3, after pretreatment with mitomycin C. CONCLUSION: We demonstrated the presence of the apoptosis-receptor system in hLECs. Furthermore, we demonstrated the possibility of the induction of key proteins of the apoptotic signalling cascade in these cells by the antimetabolic drug mitomycin C. This could have important implications on the strategies regarding both the prevention and the treatment of PCO after cataract surgery.

Antimetabolites↗

Effects of doxorubicin, mitomycin C, and ethanol on Hep-G2 cells in vitro.

There are conflicting results for experiments aimed at determining whether anticancer drug therapy of human hepatocellular carcinoma prolongs the survival rate effectively. The purpose of this study was to assess the effect of low concentrations of doxorubicin, mitomycin C, and ethanol on cell replication (cell number and proliferation), and cell apoptosis of cultured human hepatocellular carcinoma (Hep-G2) cells. After 1 day of exposure doxorubicin inhibited cell replication initially by 72%, but a partial recovery of the cell number was observed. Mitomycin C inhibited to the same extent but without recovery. Ethanol reduced the cell number even further, the maximum inhibition (12 days after exposure) being 96.4%. After 3 days of exposure all three agents stopped cell replication at a level of 2%-4% of the control (P < 0.001). Cell apoptosis was activated most strikingly by mitomycin C (5 microg/ml) after 1 day of exposure and by ethanol (150 microl/ml) after 3 days of exposure. Two-way repeated-measures analysis of variance showed statistically significant differences, with ethanol being the most significant followed by mitomycin C doxorubicin, and the control (P < 0.01). Thus, a low dose of ethanol combined with an exposure time of up to 3 days appears to be an effective regimen to control growth of human hepatocellular carcinoma cells in vitro. The strong induction of apoptosis by ethanol might be of additional benefit for a local application in vivo.

Analysis of Variance↗

Genetic analysis of mitomycin C-induced interchange in Drosophila melanogaster females.

A genetic analysis of an array of mitomycin-induced rearrangements in immature Drosophila oocytes is reported. Induced aberrations were recovered representing detachments of the compound-X chromosome, Y chromosome fragments, X chromosome loss and mosaicism. The spectrum of rearrangements induced by mitomycin C was very similar to that induced by X-ray treatment of immature oocytes. This work suggests that mitomycin C has two models of action. The drug is radiomimetic for it induces the types of aberrations recovered after X-irradiation. Mitomycin C also seems to have a delayed effect which is reflected in the relatively high recovery of mosaics.

Animals↗

Studies on the mechanism of the cytotoxic action of the mitomycin antibiotics in hypoxic and oxygenated EMT6 cells.

The mitomycin antibiotics, because of their preferential toxicities for hypoxic cells, have significant potential as adjuncts to ionizing radiation in the treatment of solid tumors. To gain information on the mechanism by which these agents exert their cytotoxicities to hypoxic and aerobic cells, the effects of MC, POR and several of their analogs were studied in EMT6 mammary carcinoma cells. The rate of uptake of POR by these cells was directly correlated with the cytotoxicity produced by this agent under both hypoxia and aeration. At equivalent concentrations, uptake of POR into hypoxic cells was more rapid than into aerobic cells. Hypoxic cells also accumulated the antibiotic in concentrations well in excess of that present in the extracellular medium, presumably as a result of reductive activation and covalent binding of POR to cellular structures. Such activation and binding occur to a much lesser degree in aerated cells, resulting in the rapid efflux of POR from these cells when the antibiotic is removed from the extracellular environment. To gain information on the reaction of POR with DNA, mono- and bis-adducts formed in EMT6 cells exposed to this agent were measured. Three major adducts were formed. Two were mono-adducts consisting of deoxyguanosine linked at its N2-position to the C-1 of POR and of 10-decarbamoyl POR. The third was a bis-adduct in which POR was cross-linked to two deoxyguanosines at their N2-positions. More adducts were formed in hypoxia than in air, and more bis-adducts were present in hypoxic cells. Simultaneous exposure of cells to both POR and DIC reduced the total adduct level and a new unknown adduct was formed, primarily under hypoxia. Several mitomycins were evaluated for their capacity to kill EMT6 cells and to produce DNA cross-links in both hypoxia and aeration. The number of cross-links required to produce a given amount of cell kill was similar, regardless of the mitomycin employed or the degree of oxygenation. The findings support the concept that DNA is a critical target in the action of the mitomycins and that cross-linking of the DNA creates an important lesion for cytodestruction.

Animals↗

The induction of Robertsonian translocations by X-rays and mitomycin C in mouse cells.

The induction of Robertsonian translocations in murine C3H 10T1/2 embryo fibroblasts after exposure to X-rays and mitomycin C has been investigated. Cells were irradiated in log-phase and harvested at different times for chromosome analysis. The stage of the cell cycle of individual cells at the time of irradiation could be determined by differential replication staining. A dose-dependent delay in the progression through S- and G2-phase has been observed. X-rays produced an increase in the frequency of Robertsonian translocations when cells were exposed in G1- or S-phase, but not in G2. The dose-response curve for the induction of Robertsonian translocations both in G1 and S peaked at 2 Gy and slightly declined at higher doses. For G2 cells, an increase compared to the control level was observed only after 1 Gy. Mitomycin C induced chromosomal aberrations and Robertsonian translocations in 10T1/2 cells, but no significant interaction between ionizing radiation and the alkylating agent was observed for these two endpoints. However, the combined exposure caused satellite associations of chromosomes. Both the number of satellite associations/metaphase (five times the frequency observed after mitomycin C alone) and the number of chromosomes/satellite (up to 10 chromosomes were observed in satellite associations) were greatly enhanced compared to X-rays and mitomycin C alone.

Animals↗

An examination of the mitomycin C induction of chromosome polymorphisms in cultures of Plasmodium falciparum.

Cloned parasites of the FCR3 strain of Plasmodium falciparum that survived treatment with either mitomycin C or ethidium bromide were grown and subcloned. The chromosomes of 10 cloned isolates from each population were analysed by contour-clamped homogenous electric field gel electrophoresis. Eight of 10 isolates from the mitomycin C-treated population contained a detectable polymorphic chromosome change while none of the isolates from the ethidium bromide-treated population did. One of the polymorphic changes involved chromosome #4. A pyrimethamine resistant derivative of FCR3, FCR3-D5, that had previously been shown to contain a single nucleotide change in the dihydrofolate reductase-thymidylate synthase (DHFR-TS) gene but no detectable chromosome polymorphisms, was sequentially treated with mitomycin C and a higher concentration of pyrimethamine than the strain had previously been shown to be resistant to in order to determine if there was a correlation between the selection of chromosome #4 polymorphisms and the applied selective pressure. Most of the cloned survivors of this treatment were found to contain chromosome polymorphisms that involved chromosome #4, the chromosome on which the DHFR-TS gene is located. The polymorphic changes were usually different in the different isolates. The selection of mitomycin C-treated, pyrimethamine resistant strains with chromosome #4 polymorphisms will be discussed.

Animals↗

Radiotherapy, combined with simultaneous chemotherapy with mitomycin C and bleomycin for inoperable head and neck cancer--preliminary report.

PURPOSE: Prospectively designed randomized clinical study was undertaken to assess the efficacy of simultaneous application of irradiation, Mitomycin C, and Bleomycin in treatment of patients with inoperable head and neck carcinoma. METHODS AND MATERIALS: Between March 1991 and October 1993, 49 patients with inoperable head and neck carcinoma were randomly assigned to receive either radiation therapy alone (group A) or radiotherapy combined with simultaneous application of Mitomycin C and Bleomycin (group B). Patients in both groups were irradiated five times weekly with 2 Gy to the total dose of 66-70 Gy. Chemotherapy regimen included intramuscular application of Bleomycin 5 units twice a week, with the planned dose being 70 units and Mitomycin C 15 mg/m2 applied intravenously after delivery of 9-10 Gy of irradiation. The application of Mitomycin C was planned to be repeated on last day of radiotherapy in the dose of 10 mg/m2. In attempt to enhance the effect of chemotherapeutic drugs, patients in group B received also Nicotinamide, Chlorpromazine, and Dicoumarol. RESULTS: The difference in complete response rate between both treatment groups (24% in group A and 63% in group B) was statistically significant (p = 0.015). The difference in response rate was much more pronounced in patients with oropharyngeal carcinoma only (18% in group A compared to 81% in group B; p = 0.0003), while for all other subgroups added together, there was observed no benefit of multidrug therapy. Median follow-up was 18 months. Disease-free survival of patients in group A (9%) was significantly lower then in group B (48%) (p = 0.001). The difference between both treatment groups was even greater in patients with oropharyngeal carcinoma only: disease-free survival of these patients in group B was 66%, while in group A, all recurred (p = 0.00001). CONCLUSION: From results of our prospective randomized study it seems that the group of patients that received multidrug treatment with Mytomycin C, Bleomycin, Nicotinamide, Chlorpromazine, and Dicoumarol as enhancers of radiotherapy fared better than patients treated by radiotherapy alone.

Adult↗

Effect of cyclodextrins on the chemical stability of mitomycins in alkaline solution.

The effects of cyclodextrins on the chemical stability of several mitomycin antibiotics in an alkaline medium have been investigated. A stability-indicating high-performance liquid chromatographic method was used to determine the overall degradation rate constants. The influence of various parameters such as structural variations of the cyclodextrins and mitomycins, temperature and pH was studied. It appears that complexation is most favourable with gamma-cyclodextrin. All mitomycin-gamma-cyclodextrin complexes degrade at lower rates than those of the free drugs. Moreover, it was shown that gamma-cyclodextrin influences the equilibrium between mitomycin C and its zwitterion mesomer.

Alkalies↗

P53-independent thermosensitization by mitomycin C in human non-small-cell lung cancer cells.

PURPOSE: To elucidate the relationship between p53 functions and the interactive effects of the combined treatment with mild hyperthermia and mitomycin C. METHODS AND MATERIALS: p53-deficient human non-small-cell lung cancer H1299 cells were transfected with a vector carrying a neomycin-resistant gene (neo) or together with a wild-type or mutant p53 gene. Sensitivities of these transfectants to mild hyperthermia at 42 degrees C, mitomycin C (0.05 microg/mL) at 37 degrees C, or the combination treatment were determined by colony formation assay. After these treatments, the induction of apoptosis, the changes in cell cycle distribution, and the accumulation of Hsp72 were examined. RESULTS: The combined treatment resulted in an enhanced cell killing effect in H1299 cells in a p53-independent manner, which was partially the result of an enhancement of heat-induced apoptosis. The treatment also caused a marked G(2)/M arrest in the neo and the mutant p53 cells, but not in the wild-type p53 cells. The subsequent release of G(2)/M arrest was accompanied with an increase in the sub-G(1) fractions. Mitomycin C did not affect the accumulation of Hsp72 induced by hyperthermia in H1299 cells regardless of their p53 gene status. CONCLUSION: Our findings demonstrate a p53-independent mechanism for an interactively cytotoxic enhancement by combined treatment with mild hyperthermia and mitomycin C.

Antibiotics, Antineoplastic↗

Application of mitomycin-C for head and neck keloids.

Keloids of the head and neck are a relatively common entity in darker-skinned races, occurring in 5%-15% of skin wounds. Keloids are fibrotic lesions that are a result of an abnormal wound-healing process that lacks control of the mechanisms that regulate tissue repair and regeneration. The proliferation of normal tissue-healing processes results in scarring that enlarges well beyond the original wound margins. Many treatment modalities for keloids have been tried with variable amounts of success. Surgical excision, compressive therapy, silicon dressings, corticosteroid injections, radiation, cryotherapy, interferon therapy, and laser therapy have all been used alone or in combination. Despite this wide range of available treatments, recurrence rates typically remain in the 50%-70% range. In this study, we present our results in a series of 10 patients who were treated with surgical excision of head and neck keloids and the application of topical mitomycin-C. Mitomycin-C is a chemotherapeutic agent that inhibits DNA synthesis and fibroblast proliferation. It has been used in ophthalmologic procedures and airway surgery to decrease scar formation. In these 10 patients, we combined surgical excision of keloids with the application of topical mitomycin-C. The patients were then followed postoperatively for recurrence (range, 7-14 months). We have found topical application of mitomycin-C to be an effective therapy for prevention of keloid recurrence in the head and neck, with a success rate of 90% as reported in this series.

Adolescent↗

Meglumine Eicosapentaenoic acid (MeEPA) a new soluble omega-3 fatty acid formulation: in vitro bladder cancer cytotoxicity tests in combination with epirubicin and mitomycin.

OBJECTIVE: To determine if Meglumine-Eicosapentaenoic Acid (MeEPA) acts synergistically with epirubicin and mitomycin to enhance cytotoxicity towards bladder cancer cell lines in vitro. MATERIALS AND METHODS: Bladder cancer cells were exposed to MeEPA in combination with epirubicin or mitomycin. Residual viable cell biomass was estimated with the methyl-thiazoldiphenyl tetrazolium (MTT) assay following drug exposure. Drug interaction was analysed using median effect analysis to determine levels of synergism. RESULTS: Most combinations of MeEPA with both epirubicin and mitomycin showed a high-level of synergism. At high doses, drug precipitation adversely affected MTT assay analysis suggesting antagonism of action. However, the predominant pattern was of synergism for most dose combinations tested. CONCLUSION: Bladder cancer treated by endoscopic resection alone is subject to high recurrence rates. Post-operative intravesical instillation of epirubicin and mitomycin can halve recurrence rates, but there is no evidence that disease progression to invasive bladder cancer is altered. Thus, optimisation of current treatment strategies is required. The anti-tumour activity of fatty acids is well established and MeEPA is a new, soluble formulation with the potential to enhance intravesical drug efficacy.

Antibiotics, Antineoplastic↗

Chemoradiation with 5-fluorouracil and mitomycin C in the treatment of vulvar squamous cell carcinoma.

OBJECTIVE: To investigate the acute and late toxicities associated with the use of chemoradiation therapy (CRT) with 5-fluorouracil (5-FU) and mitomycin C or mitomycin C alone for primary, adjuvant, and salvage therapy for vulvar cancer. METHODS: Medical charts of 17 patients who received CRT with this regimen were reviewed. Toxicity was scored by 1998 standardized common toxicity criteria, Version 2.0, for acute toxicity and the RTOG/EORT Late Radiation Morbidity Scoring Schema for late toxicity. Median follow-up was 20 months (range: 5-74 months). RESULTS: Six patients had grade 4 neutropenia. In three patients, life-threatening neutropenic sepsis developed after the second cycle of chemotherapy. Severe enterocolitis was a direct cause of death in two patients. In four patients, the second cycle of chemotherapy was cancelled because of severe toxicity associated with the first cycle. One patient had grade 4 skin toxicity in the vulvar-perineal area. Six patients had grade 3 and seven patients had grade 2 acute skin toxicity. Skin toxicity necessitated the interruption of CRT in nine patients at a median dose of 32.4 Gy (range: 16.2-48 Gy). One patient developed bowel perforation and colovaginal fistula 1.5 years after completion of CRT. CONCLUSION: Chemoradiation therapy utilizing 5-FU and mitomycin C or mitomycin C alone in the treatment of vulvar cancer can be associated with a high incidence of morbidity and mortality. Strict attention to indications for treatment interruptions or chemotherapy dose adjustments is obligatory for safe delivery of CRT to these patients.

Aged↗

Needle elevation of the scleral flap for failing filtration blebs after trabeculectomy with mitomycin C.

PURPOSE: To report the incidence of failing filtration blebs after trabeculectomy with mitomycin C and to report the outcome of needling procedures for failing filtration blebs in these eyes. METHODS: We conducted a retrospective analysis of 537 eyes of 434 patients who had trabeculectomy with mitomycin C and reviewed the clinical course of 441 eyes of 338 patients with a minimum of three months of follow-up. RESULTS: In 441 eyes of 338 patients followed up for three months or more after trabeculectomy with mitomycin C, 88 (20.0%) eyes from 85 patients underwent needle elevation of the scleral flap. Forty-nine (22.4%) of 219 eyes required needle revision after trabeculectomy alone, and 39 (17.6%) of 222 eyes after trabeculectomy combined with cataract extraction and intraocular lens implantation. Mean intraocular pressure (IOP) after needle revision (17.9 +/- 11.6 mm Hg) was significantly less than the mean preneedling IOP (27.1 +/- 10.4 mm Hg, P < .00001, paired Student's t test). Sixty-three eyes of 60 patients had a minimum of three months of postneedling follow-up. Successful pressure control, defined as an IOP of 22 mm Hg or less with or without topical glaucoma control medications, was achieved in 46 (73.0%) of 63 eyes. Unsuccessful outcomes correlated significantly with higher preneedling IOP (R = 0.28, P = .03, df = 61) and prior surgery involving conjunctival incisions (R = 0.53, P < .00001, df = 61). CONCLUSIONS: Needle elevation of the scleral flap may provide significantly long-lasting pressure reduction in eyes with failing mitomycin C blebs. Higher success rates are achieved in eyes with fewer prior conjunctival incisions, eyes requiring a single needle revision, and eyes with lower preneedling IOP.

Adult↗

A randomized trial comparing mitomycin C and conjunctival autograft after excision of primary pterygium.

PURPOSE: To determine the rate of recurrence and complications after bare sclera excision of primary pterygia followed by low-dose mitomycin C (0.2 mg/ml twice daily for five days), placebo (balanced saline solution), or conjunctival autograft. METHODS: We performed a prospective, double-masked clinical trial of 64 patients (60 Hispanic) randomly assigned to a treatment group. Twenty-four patients received mitomycin C, 23 conjunctival autograft, and 17 placebo. Recurrence was defined as fibrovascular tissue over the corneoscleral limbus onto clear cornea in the area of previous pterygium excision. RESULTS: The recurrence rate after mitomycin C and conjunctival autograft was 38% and 39% of eyes, respectively, after mean follow-up (in recurrence-free patients) of 12.3 and 13.5 months, respectively. The recurrence rate after placebo treatment was significantly higher (P = .002), 88%, after mean follow-up (in recurrence-free patients) of 9.3 months. Increasing age was associated with significantly fewer recurrences (P = .006) after controlling for pterygium type (atrophic, noninflamed, or inflamed) and treatment group. The mean time to recurrence varied from 3.7 to 4.8 months; only 6% of recurrences were noted after the sixth postoperative month. Major complications included symblepharon (two), loose autograft (one), and pyogenic granuloma (two). No group had significantly more complications. CONCLUSIONS: Conjunctival autograft and low-dose topical mitomycin C are equally effective as adjunctive treatment after excision of primary pterygia in this young, southern California, predominantly Hispanic population. Both methods have significantly lower rates of recurrence than bare sclera excision alone, and neither is associated with severe complications after one year of follow-up. Increasing patient age is associated with significantly less risk of recurrence.

Administration, Topical↗

Histopathologic effects of mitomycin C after trabeculectomy in human glaucomatous eyes with persistent hypotony.

We evaluated the histopathologic findings in seven patients who underwent surgical revision of the filtration site after trabeculectomy with mitomycin C because of persistent hypotonous maculopathy. Light microscopic examination of subconjunctival tissue and sclera demonstrated hypocellularity of fibroblasts and disruption of the normal architecture. Tissue fragments at the margin of the bleb wall demonstrated scarring and contained multiple fibroblasts. Additionally, we investigated the histopathologic changes in an eye obtained from a patient who died one week after a trabeculectomy with mitomycin C. Transmission electron microscopy showed myelin figures, increased melanolipofuscin granules, vacuolated cytoplasm, and disrupted mitochondria of the ciliary body epithelium underlying the site of mitomycin C application. On the basis of these findings, both overfiltration because of tissue disorganization of the filtering bleb and aqueous hyposecretion because of ciliary body toxicity might be involved in the causes of persistent hypotony after mitomycin C trabeculectomy.

Adult↗

Limbus-based vs fornix-based conjunctival flap in combined glaucoma and cataract surgery with adjunctive mitomycin C.

PURPOSE: To determine the efficacy and safety of limbus-based vs fornix-based conjunctival flaps in patients with primary open-angle glaucoma undergoing trabeculectomy combined with phacoemulsification and intraocular lens implantation with adjunctive subconjunctival mitomycin C. METHODS: In a prospective study, 69 eyes of 69 patients with primary open-angle glaucoma, visually symptomatic cataracts, and no previous incisional ocular surgery were randomly assigned to limbus-based and fornix-based conjunctival flap groups. All patients received trabeculectomy combined with phacoemulsification and posterior chamber lens implantation with 1-minute (0.5 mg/ ml) application of subconjunctival mitomycin C. RESULTS: The mean intraocular pressures were significantly (P < .05) lower on significantly (P < .05) fewer medications postoperatively at 1 week, 1 month, 3, 6, 9, 12, and 15 to 18 months, and at last follow-up in both groups than they had been preoperatively. However, there were no significant (P > .05) differences in postoperative mean intraocular pressure, mean number of medications, and visual acuity between the two groups at any time interval. Hypotony with wound leak was significantly (P = .019) higher in the limbus-based group. Other postoperative complications were not significantly (P > .05) different between the two groups. CONCLUSIONS: There was no notable difference in glaucoma control or visual outcome between limbus-based and fornix-based conjunctival flaps in primary trabeculectomy combined with phacoemulsification and lens implantation with adjunctive subconjunctival mitomycin C. The fornix-based flap was as safe as, if not safer than, the limbus-based flap in the glaucoma triple procedure with adjunctive subconjunctival mitomycin C.

Aged↗