Efficacy and safety of adjunctive mitomycin C during Ahmed Glaucoma Valve implantation: a prospective randomized clinical trial. A placebo-controlled, double-masked evaluation of mitomycin C in combined glaucoma and cataract procedures. A randomized study of mitomycin augmentation in combined phacoemulsification and trabeculectomy. The Madurai Intraocular Lens Study. II: Clinical outcomes. The effect of mitomycin C on Molteno implant surgery: a 1-year randomized, masked, prospective study. The South Asian cataract management study: complications, vision outcomes, and corneal endothelial cell loss in a randomized multicenter clinical trial comparing intracapsular cataract extraction with and without anterior chamber intraocular lens implantation. Effects of dexamethasone, diclofenac, or placebo on the inflammatory response after cataract surgery. [Long-term follow-up study on Hunan aqueous drainage implantation combined with mitomycin C for refractory glaucoma]. 5-fluorouracil in combined trabeculectomy and clear-cornea phacoemulsification with posterior chamber intraocular lens implantation. A one-year randomized, controlled clinical trial.
To evaluate the efficacy and safety of intraoperative mitomycin C (MMC) in eyes undergoing Ahmed Glaucoma Valve implantation.
                Randomized controlled clinical trial.
                Sixty patients with refractory glaucoma.
                Sixty eyes of 60 patients with refractory glaucoma were randomized to receive intraoperative MMC (0.5 mg/ml for 5 minutes) (n = 34) or balanced salt solution (n = 26) during Ahmed Glaucoma Valve implantation.
                Surgical success was defined according to 2 different criteria: (1) postoperative intraocular pressure (IOP) between 6 and 21 mmHg, with or without antiglaucoma medications, and (2) IOP reduction of at least 30% relative to preoperative values. Eyes requiring additional glaucoma surgery, developing phthisis, or showing loss of light perception were classified as failures. Success rates in both groups were compared using Kaplan-Meier survival curves and the log rank test. Other outcome measures were mean IOP, number of glaucoma medications, and complications.
                After a mean follow-up of 12.3 months, Kaplan-Meier survival analysis showed a probability of success of 59% at 18 months for the MMC group and 61% for the control group when the first criterion for success was used (IOP between 6 and 21 mmHg). When an IOP reduction of at least 30% was used as the criterion to define success, the Kaplan-Meier survival analysis demonstrated a probability of success at 18 months of 62% for the MMC group and 67% for the control group. There were no significant differences in survival rates between the 2 groups with either criterion (P = 0.75 and P = 0.37, respectively). After 15 days postoperatively, the mean IOP did not significantly differ for both MMC and control eyes. Mean numbers of postoperative antiglaucoma medications were similar in MMC-treated eyes and controls. There was no significant difference between the incidences of postoperative complications in both groups.
                Mitomycin C did not increase the short- or intermediate-term success rates of Ahmed Glaucoma Valve implantation. This study was performed to determine if adjunctive use of mitomycin C (MMC) would increase the success of combined phacoemulsification, intraocular lens implantation, and trabeculectomy surgery with releasable sutures.
                Seventy-two eyes with cataract and glaucoma, requiring surgery for decreased vision, uncontrolled intraocular pressure, or to obtain a better view of the optic nerve, were randomized to receive a 2.5-minute subconjunctival exposure to either MMC (0.5 mg/ml) or placebo balanced salt solution. Postoperative evaluations at 3, 6, and 12 months were performed by a masked observer who recorded visual acuity, intraocular pressure, glaucoma medications, presence of filtering blebs, and complications. Endothelial cell counts were measured before and 3 months after surgery.
                The MMC group had significantly greater reduction in mean intraocular pressure through the first 12 months of follow-up (7.05-7.65 mmHg versus 2.62-3.84 mmHg; P = 0.001-0.028). In addition, through the first 6 months of follow-up, the MMC group required significantly fewer medications (0.4-0.5 versus 1.1-1.2; P = 0.002-0.004). Requirements for additional glaucoma surgery were less in the MMC group (4/ 36) than in the placebo group (7/35) (P = 0.301). Filtering blebs were significantly larger at 6 and 12 months (P = 0.002 and P = 0.001, respectively), and would leaks were more common (P = 0.101) in the MMC group. The mean decrease in endothelial cell count at month 3 was slightly, although not significantly, greater in the MMC treatment group (206.9 versus 91.3 cells/mm2* P = 0.377).
                The increased success of the glaucoma procedure in the MMC group together with relatively minor toxicity, suggests its use is beneficial in combined glaucoma-cataract surgery. The purpose of the study is to determine whether the intraoperative application of subconjunctival mitomycin C (MMC), during combined phacoemulsification and trabeculectomy, is an effective means of improving filtration, defined as overall lower intraocular pressure (IOP) and less antiglaucoma medication use.
                Twenty-nine patients with a visually significant cataract and glaucoma were randomized, in a double-masked fashion, to receive intraoperative MMC (0.5 mg/ml) or placebo.
                Follow-up ranged from 6 to 30 months (mean, 20 months). Postoperative visual acuity at 1 year was 20/40 or better in 14 of 15 eyes operated on in the placebo group and 13 of 14 eyes operated on in the MMC group. Intraocular pressure at 8 months averaged 15.2 +/- 1.5 mmHg in the placebo-treated eyes versus 12.3 +/- 1.6 mmHg in the MMC-treated eyes. At 12 months, IOPs averaged 16.2 +/- 1.5 mmHg in the placebo-treated eyes versus 12.6 +/- 1.0 mmHg in the MMC-treated eyes. On average, the MMC group had postoperative IOP levels 3.0 mmHg lower than did the placebo group (P = 0.04) throughout the study. In the placebo group, laser suture lysis was required in a greater number of patients (80% versus 43%) and to a greater extent (mean = 2.0 versus 0.7 suture lysed) (P < 0.05). At 12 months, 5 of the 15 patients in the placebo group required an average of 1.8 medications for IOP control, whereas 0 of the 14 patients in the MMC group needed IOP-lowering medications. A late endophthalmitis developed through an intact bleb in one patient in the MMC group; otherwise, complications were minimal in each group.
                These results suggest that intraoperative MMC application, during combined phacoemulsification and trabeculectomy surgery, does improve early filtration as shown by overall lower IOPs and less antiglaucoma medication use. To evaluate the safety and efficacy of extracapsular cataract extraction with posterior chamber intraocular lens (ECCE/PC-IOL) compared with intracapsular cataract extraction with aphakic glasses (ICCE-AG).
                In a nonmasked randomized controlled clinical trial, 3,400 bilaterally vision-impaired patients aged 40 to 75 years with operable cataract were randomly assigned to receive either ICCE-AG or ECCE/PC-IOL at the Aravind Eye Hospital in India. The surgery was performed by one of four study surgeons. Patients were hospitalized for 5 postoperative days, with follow-up visits at 2, 6, and 12 months after discharge. Postsurgery evaluations were conducted by two independent study ophthalmologists.
                At any single postoperative follow-up time point, there were no statistically significant differences of clinical relevance between treatment groups for any complication of a serious nature except cystoid macular edema, which was more common with ICCE (4.2% vs 1.6%). In general, whether of a trivial, intermediate, or serious nature, complication rates were low at each evaluation time point. Cumulatively, the incidence of serious complications of all types throughout the 1-year study period was 14.5% for patients in the ICCE-AG group and 7.7% in the ECCE group (P < .001). Best-corrected visual acuity of 20/40 or better at 12 months was attained by 90.7% of ICCE-AG patients and 96.3% of ECCE/PC-IOL patients (P < .001).
                Although both operative procedures are safe and effective for cataract patients with bilateral impairment, ECCE/PC-IOL is superior to ICCE-AG in terms of both visual acuity restoration and safety. The authors assess whether adjunctive mitomycin C improves Molteno tube shunt surgery in terms of intraocular pressure (IOP), visual acuity, and complication rates.
                Twenty-five eyes of twenty-five consecutive patients undergoing double-plate Molteno implant surgery were randomized to receive either mitomycin C (MMC) 0.4 mg/mL for 2 minutes or a control balanced salt solution in a masked, prospective study. Intraocular pressure, visual acuity, and complications were recorded 1 week and 1, 3, 6, and 12 months after surgery. A repeated measures analysis of variance (ANOVA) model was used to test the overall effect of the drug on IOP and percent change from preoperative IOP.
                Thirteen eyes received balanced salt solution and 12 eyes received MMC. There was no difference between the groups with respect to age, preoperative IOP, log mean angle of resolution (LogMar) visual acuity, or number of preoperative medications. Except for week 1, there were no differences between the groups at any of the clinic visits with respect to IOP and percent change from baseline IOP. Analysis of the visual acuity (LogMar) showed reduction in vision for both groups. Complications were similar in each group, as were number of postoperative hypotensive agents required.
                Adjunct MMC does not demonstrate a significant difference in outcomes compared with placebo in pressure-ridged Molteno implant surgery. Results of this study are limited by a small number of patients in each group and a fixed dose of MMC. To determine clinical outcomes of primary intracapsular cataract surgery with and without implantation of anterior chamber lenses.
                A multicenter randomized clinical trial.
                One thousand two hundred twenty-nine male and female patients 40-75 years of age with senile cataract.
                Study patients were recruited from screening eye camps and outpatient clinics. Randomization to the two treatment groups was performed after screening for predetermined inclusion and exclusion criteria. Demographics, visual acuity, intraocular pressures, and corneal endothelial cell data were recorded before surgery and at 6 weeks, 12 months, and 24 months after surgery. Monitoring of the study was secured by a standardized image documentation procedure on all patients using the IMAGEnet digital imaging system. Analysis of corneal endothelial cell images was performed with the Cell Soft software (Topcon Corporation, Japan).
                Visual acuity and central corneal endothelial cell loss.
                The patients were randomized to intraocular lens (IOL; n = 616) and no IOL (n = 613) implantation. Surgical complications were reported in 177 (14.4%) patients (IOL = 14.8%; no IOL = 14.0%). The most frequent complication observed was vitreous loss which occurred in 10.3% of eyes (IOL = 11.2%; no IOL = 9.5%). At the final examination (2 years after surgery), 88% of the operated eyes had a best corrected vision of 6/18 or better (IOL = 88.8%; no IOL = 86.6%). Analysis of corneal endothelial cell data showed a small but significantly greater cell loss 6 weeks after surgery in eyes with IOL compared with those without IOL, but no overall difference was found between the treatment groups in the long term follow-up.
                The findings indicate that there is a rationale for the use of anterior chamber intraocular lenses in primary intracapsular cataract surgery. To compare the inflammatory response after phacoemulsification and intraocular lens (IOL) implantation using postoperative treatment with dexamethasone, diclofenac, or placebo.
                A prospective, randomised, controlled double masked study including 180 patients enrolled for cataract surgery. The patients were 64-85 years old and had no eye disease other than cataract. After phacoemulsification and IOL implantation the patients were randomised to topical treatment with dexamethasone phosphate 0.1% (group I), diclofenac sodium 0.1% (group II), or placebo (saline 0.9%) (group III). The drops were administered four times daily during the first week and twice daily during the second, third, and fourth weeks. The inflammatory reaction in the anterior chamber was measured with laser flare photometry preoperatively and 1, 3, and 8 days, 2 and 4 weeks, 2 and 6 months, and 1, 2, and 4 years postoperatively. Inflammatory symptoms were registered. Biomicroscopy and visual acuity determinations were performed. The rate of Nd:YAG laser posterior capsulotomies after 2 and 4 years was determined.
                After 3 and 8 days (p <0.0001), 2 weeks (p <0.0001), and 1 month (p = 0.0013) median flare was highest in group III. There were no significant differences between group I and II. Inflammatory symptoms and striate keratopathy were more common in group III.
                Dexamethasone and diclofenac were equally effective in reducing postoperative inflammation after phacoemulsification and IOL implantation in eyes with no other disease than cataract. Both substances were more effective than placebo. To investigate the long-term therapeutic effect of Hunan aqueous drainage (HAD) implantation with and without adjunctive intraoperative mitomycin C (MMC) for refractory glaucoma.
                154 cases (159 eyes) with refractory glaucoma underwent Hunan aqueous drainage (HAD) implantation from July 1995 to July 2001. Sixty-five eyes were combined with MMC (0.4 mg/ml, 1 to 5 mins). With success defined as the introcular pressure (IOP) greater than 6 mmHg but no greater than 21 mmHg at the last visit.
                The mean period of postoperative follow-up was 54.6 (range, 12-72) months. The IOP was lowered from preoperative (46.8 +/- 14.5) mmHg to postoperative (16.8 +/- 11.3) mmHg at the 1st year after surgery. The success rate with MMC and without MMC were 90.0%, 77.3% (P < 0.05) at the 1st year, 87.1%, 67.3% (P < 0.05) at the 2nd year, 83.3%, 61.1% (P < 0.05) at the 3rd year, 81.3%, 56.7% (P < 0.05) at the 4th year, and 75.0%, 50.0% (P < 0.05) at the 5th year using Kaplan-Meier life-table analysis. The height of the posterior bleb underwent standardized ocular echography at the 1st year was (3.8 +/- 0.9) mm and (2.1 +/- 1.4) mm, respectively. Ninty-five eyes (81.9%) with visual acuity remained or improved after the surgery (P > 0.05). The most frequent complications for long-term follow-up included elevated IOP (IOP > 22 mmHg) (19.8%), the iris adherent to the proximal orifice of the tube (15.5%), developed cataract formation (12.9%) and so on (P > 0.05). We didn't find any severe complications after using MMC.
                This study suggests that HAD implantation is an effective method in the management of refractory glaucoma in spite of its unneligible complications and combined with MMC can improve the prognosis. To test the effect of postoperative subconjunctival 5-fluorouracil (5-FU) on the pressure outcome in combined procedure (limbus-based trabeculectomy + clear-cornea phacoemulsification).
                Prospective randomized, controlled clinical trial; n = 24 eyes (24 patients) with concurrent open-angle glaucoma and cataract; 12 eyes per treatment group; sample size adjusted for a minimal expected difference in the event rate between the 2 treatment groups = 50%, control rate = 20%; type I error = 0.05; power = 95%. Uncomplicated limbus-based trabeculectomy + uncomplicated clear-cornea phacoemulsification + posterior chamber intraocular lens. The 5-FU group = five subconjunctival injections of 5 mg 5-FU, starting from day 8 after surgery, one injection per week. Control group = no injections. The groups were matched for age, preoperative intraocular pressure (IOP), duration of preoperative antiglaucoma treatment, preoperative pilocarpine and adrenergics, preoperative laser trabeculoplasty, and beta-blockers in the fellow eye. The IOP less than or equal to 15 mmHg without treatment 1 year after surgery (IOP = average of the two highest values measured in the diurnal curve, 8 AM to 6 PM, one reading every 2 hours).
                Each patient completed a 1-year follow-up. Ten of 12 eyes of the 5-FU group showed an IOP less than or equal to 15 mmHg at the end of follow-up versus 1 of 12 eyes in the control group (Fisher's exact test, P = 0.00064). The IOP range was 10 to 17 mmHg in the 5-FU group and 14 to 22 mmHg in the control group.
                Postoperative 5-FU may improve the 1-year success rate of trabeculectomy combined with clear-cornea phacoemulsification.
Intraoperative MMC reduces the risk of surgical failure in eyes that have undergone no previous surgery and in eyes at high risk of failure. Compared to placebo it reduces mean IOP at 12 months in all groups of participants in this review. Apart from an increase in cataract formation following MMC, there was insufficient power to detect any increase in other serious side effects such as endophthalmitis.