| Popis: |
Objective: 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 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. |
