Purpose: To compare IOP behavior after deep sclerectomy (DS) and trabeculectomy with the Crozafon-De Laage Punch (TP), using low-dosage intraoperative mitomycin C (MMC) in both techniques. Methods: The study was a prospective randomized clinical trial. All patients met inclusion and exclusion criteria, and werescheduled for glaucoma surgery. Forty patients were randomized to undergo either a nonpenetrating DS with MMC (DSMMC) (19 eyes) or a TP with MMC (TPMMC) (21 eyes). Postoperative examinations were performed at the 1st day, the 1st, 2nd and 3rd weeks and the 1st, 3rd, 6th, 9th and 12th months. Postoperative complications,number of antiglaucoma medications and the IOPlevel were checked at each control. Complete success (without antiglaucoma medications) and qualifi ed success (with or without medications) were assessed at two target IOP levels, namely ^ 21 and ^ 17 mm Hg in both groups. Moreover, the success rates at ^ 21 mm Hg target IOP level were compared with those from previous series of patients who had undergone DS without MMC(historical control group). Results: Data from all eyes were available until the 12th month. The mean preoperative IOP 8 SD was 29.6 8 5.8 mm Hg in DSMMC eyes, 28.0 8 6.0 in TPMMC eyes; the mean IOP at the 1st post-operative day was 12.5 8 4.2 and 13.9 8 6.5 mm Hg, while at the endpoint the mean IOP was 14.5 8 4.0 and16.1 8 3.8, respectively, with signifi cant reduction (p 0.0005) of the preoperative IOP in both groups. Complete success ( ^ 21 mm Hg target IOP) in 15 eyes (78.9%) of the DSMMC group and in 15 eyes (71.4%) of the TPMMCgroup was respectively found, while qualifi ed success was achieved in all the eyes. When a ^ 17 mm Hg target IOP was considered, complete success in 12 eyes (63.1%)and 13 eyes (61.9%), and qualifi ed success in 13 eyes (68.4%) and 15 eyes (71.4%) were found in the DSMMC and TPMMC groups, respectively. No signifi cant intergroupdifferences were found in terms of success rate.There is no statistical signifi cance in the Kaplan-Meier cumulative survival curves as for complete and qualified success rate in both surgical groups for a ^ 17 mm Hg target IOP (log rank, p = 0.918 and p = 0.429, respectively).As for the frequency of postoperative complications, hypotony and shallow anterior chamber were significantly more frequent in TPMMC when compared with the DSMMC group. The historical comparison between the DSMMC group and simple DS cases shows no significant difference between the groups, with a mild positive trend in DSMMC when compared with DS eyes.Conclusions: Both techniques, DSMMC and TPMMC,control IOP effi caciously at our endpoint. Our results indicate that low-dosage MMC can be considered a mild enhancement of DS IOP lowering effect without any negative effect on the well-known intra- and postoperative safety of the technique.
|Numero di pagine||6|
|Stato di pubblicazione||Published - 2005|
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