Ologen versus Mitomycin-C for Trabeculectomy (jedd)

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To investigate the efficacy and safety of the collagen-based Ologen implant as an adjuvant therapy in trabeculectomy as compared to mitomycin-C (MMC) in a predominantly African American patient population. Methods: This study was a retrospective review of 54 eyes of 50 primary open angle glaucoma patients who underwent trabeculectomy with either MMC or Ologen. 16 eyes were included in the MMC group and 38 in the Ologen group. Primary outcomes included treatment success (as defined by target IOP <21 mmHg, IOP reduction >20) both qualified (with and without medications) and unqualified (without medication), overall IOP reduction, and reduction of number of medications as compared to pre-operative state. Secondary outcomes included evaluation of treatment adverse events. Results: No significant differences were noted between the two groups in comparing rates of qualified and unqualified success (p=0.308 and p=0.343, respectively). IOP reduction was seen for both groups at 3, 6, and 12 months, but no statistically significant differences were reached (p=0.94, 0.88, and 0.84, respectively). When examining medication reduction from pre-operative states, a significant difference in medication reduction was seen at the 6-month time point for the Ologen group as compared to the MMC group (p=0.005). No significant differences were reached for the 3 or 12-month time points (p=0.051, 0.341, respectively). A significantly higher rate of postoperative bleb leak was noted with MMC as compared with Ologen (p=0.009). No other adverse events showed differences between the two treatment groups. Conclusion: Our findings suggest that Ologen is at least as effective as MMC in IOP reduction, reduction of postoperative medication use, and success rates when used as adjuvant therapy in trabeculectomy in a predominantly African American population. Ologen is also a safer option for patients of the same demographic demonstrated by lower rates of adverse events as compared to MMC.

Glaucoma is the most common cause of irreversible blindness worldwide [1]. Treatment of glaucoma begins with medical management but oіen requires surgical intervention. Since the late 1960s, the most common surgical treatment for glaucoma has been trabeculectomy [2-4]. AGIS investigators and others have established that race plays a significant role in an individual’s response to trabeculectomy [5-7]. 6pecificall\, African American patients have been shown to have advanced glaucoma at time of diagnosis and respond less favorably than Caucasian patients to trabeculectomy [5-14]. Our group wishes to investigate the role of ethnicity in specific surgical treatments for glaucoma. Another issue pertaining to the failure of surgical intervention for glaucoma is post-operative wound scar formation resulting in fibrosis and obstruction of outflow, which remains the number one cause of failed trabeculectomies [15-17]. Mitomycin-C (MMC) is a commonly used intra-operative, anti-tumor metabolite that reduces postoperative fibrosis and scarring [18]. However, the existence of adverse eوٴects of MMC, such as bleb leaks and avascular blebs [19], have led to the investigation of Ologen (Aeon Astron Europe B.V., Leiden, Нe Netherlands), a collagen glycosaminoglycan matrix implant, as another adjuvant therapy for trabeculectomy. In recent studies, some investigators have found that trabeculectomy with Ologen oوٴers similar results as compared to MMC with no statistically significant diوٴerence in outcomes or complications between the two [20-24]. Others have found that Ologen oوٴers less reduction in intra-ocular pressure (IOP), an increase in some complications, and lower complete and qualified success rates [25,26]. A more recent study looking at a longer term outcomes reported Ologen as significantl\ more successful than MMC in trabeculectomy patients [27]. No studies to this date have compared the eٹcac\ of Ologen to MMC in African American patients. Нe fact remains that African American patients tend to have more progressed glaucoma at time of diagnosis and also have a lower rate of response to trabeculectomy. Given that current literature demonstrates conflicting evidence regarding the eٹcac\ of trabeculectomy with MMC versus Ologen, the purpose of this study was to directly compare these two adjuvant therapies in a particularly vulnerable population of glaucoma patients. Our hypothesis was that trabeculectomy with Ologen would be at least as eوٴective as trabeculectomy with MMC in African American patients.

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