AIM: To compare the efficacy and safety of collagen matrix implant [Ologen (OLO) implant] versus mitomycin C (MMC) with subscleral trabeculectomy (SST) for the surgical treatment of congenital glaucoma (CG) in Sturge-Weber Syndrome (SWS). METHODS: A prospective comparative randomized study of 20 eyes of 16 patients with CG associated with SWS was divided into two groups. The first group (MMC Group) included 10 eyes that were subjected to SST with MMC. The second group (OLO Group) included 10 eyes that were subjected to trabeculectomy with a collagen matrix implant (OLO implant). Postoperative evaluation included intraocular pressure (IOP) level, bleb evaluation, complications, and the need for further medication or surgical intervention. RESULTS: The mean preoperative IOP was 29±3.16 mm Hg in MMC and 29.8±3.08 mm Hg in OLO eyes. Mean 12-month percentage reduction in IOP was significant in both groups (57.9% and 56.3%). At the end of the 12 postoperative follow-up month, in the MMC Group, 80% of eyes achieved the complete success, 20% of eyes had qualified success with no failed surgery in comparison to OLO Group which 70% of eyes achieved the complete success, 20% of eyes had qualified success with 10% failed surgery. In terms of complications, the MMC Group had a higher rate of complications than the OLO Group in the form of thin polycystic bleb in 6 eyes (60%), blebitis in only one eye (10%) treated with topical antibiotics, shallow anterior chamber in two eyes (20%). CONCLUSION: This study proves that the use of a collagen matrix implant yields equally effective results as MMC when combined with trabeculectomy for the treatment of CG in SWS. Furthermore, OLO implantation is safe and has low incidences of complications.
RCT Entities:
AIM: To compare the efficacy and safety of collagen matrix implant [Ologen (OLO) implant] versus mitomycin C (MMC) with subscleral trabeculectomy (SST) for the surgical treatment of congenital glaucoma (CG) in Sturge-Weber Syndrome (SWS). METHODS: A prospective comparative randomized study of 20 eyes of 16 patients with CG associated with SWS was divided into two groups. The first group (MMC Group) included 10 eyes that were subjected to SST with MMC. The second group (OLO Group) included 10 eyes that were subjected to trabeculectomy with a collagen matrix implant (OLO implant). Postoperative evaluation included intraocular pressure (IOP) level, bleb evaluation, complications, and the need for further medication or surgical intervention. RESULTS: The mean preoperative IOP was 29±3.16 mm Hg in MMC and 29.8±3.08 mm Hg in OLO eyes. Mean 12-month percentage reduction in IOP was significant in both groups (57.9% and 56.3%). At the end of the 12 postoperative follow-up month, in the MMC Group, 80% of eyes achieved the complete success, 20% of eyes had qualified success with no failed surgery in comparison to OLO Group which 70% of eyes achieved the complete success, 20% of eyes had qualified success with 10% failed surgery. In terms of complications, the MMC Group had a higher rate of complications than the OLO Group in the form of thin polycystic bleb in 6 eyes (60%), blebitis in only one eye (10%) treated with topical antibiotics, shallow anterior chamber in two eyes (20%). CONCLUSION: This study proves that the use of a collagen matrix implant yields equally effective results as MMC when combined with trabeculectomy for the treatment of CG in SWS. Furthermore, OLO implantation is safe and has low incidences of complications.