PURPOSE: To present the preliminary results of our study comparing the outcomes of trabeculectomy with or without OloGen implant in patients requiring glaucoma surgery for uncontrolled intraocular pressure (IOP). METHODS:Forty eyes of 40 patients were assigned randomly to undergo trabeculectomy either with OloGen implant (study group) or without implant (control group). Preoperative data included age, gender, type of glaucoma, IOP and number of preoperative glaucoma medications. Postoperative IOP, number of postoperative glaucoma medications and postoperative complications were recorded. Each patient was followed up for at least 6 months. RESULTS: There were no significant differences between the groups in terms of age, gender, type of glaucoma, preoperative IOP and number of antiglaucoma medications. Mean IOPs for both groups were significantly lower than preoperative levels at all intervals (P < 0.05) The number of glaucoma medications used dropped from a preoperative mean of 3.5 +/- 0.7 to a 6-month postoperative mean of 0.3 +/- 0.7 (P < 0.001) in the study group and from 3.7 +/- 0.4 to 0.5 +/- 1.1 (P < 0.001) in the control group. No statistically significant differences between the two groups were observed in terms of postoperative complications. CONCLUSION: In this pilot study it appears that trabeculectomy with OloGen does not seem to offer any significant advantages compared with trabeculectomy alone. Additionally, even though there were no statistical differences between the two groups as far as complications were concerned, one eye from the study group developed endophthalmitis 10 days after surgery and two eyes presented with positive Seidel test and flat anterior chamber and required additional suturing. Studies with larger numbers of patients and longer follow-ups are required to confirm these findings and to examine the safety and long-term outcomes of trabeculectomy with OloGen.
RCT Entities:
PURPOSE: To present the preliminary results of our study comparing the outcomes of trabeculectomy with or without OloGen implant in patients requiring glaucoma surgery for uncontrolled intraocular pressure (IOP). METHODS: Forty eyes of 40 patients were assigned randomly to undergo trabeculectomy either with OloGen implant (study group) or without implant (control group). Preoperative data included age, gender, type of glaucoma, IOP and number of preoperative glaucoma medications. Postoperative IOP, number of postoperative glaucoma medications and postoperative complications were recorded. Each patient was followed up for at least 6 months. RESULTS: There were no significant differences between the groups in terms of age, gender, type of glaucoma, preoperative IOP and number of antiglaucoma medications. Mean IOPs for both groups were significantly lower than preoperative levels at all intervals (P < 0.05) The number of glaucoma medications used dropped from a preoperative mean of 3.5 +/- 0.7 to a 6-month postoperative mean of 0.3 +/- 0.7 (P < 0.001) in the study group and from 3.7 +/- 0.4 to 0.5 +/- 1.1 (P < 0.001) in the control group. No statistically significant differences between the two groups were observed in terms of postoperative complications. CONCLUSION: In this pilot study it appears that trabeculectomy with OloGen does not seem to offer any significant advantages compared with trabeculectomy alone. Additionally, even though there were no statistical differences between the two groups as far as complications were concerned, one eye from the study group developed endophthalmitis 10 days after surgery and two eyes presented with positive Seidel test and flat anterior chamber and required additional suturing. Studies with larger numbers of patients and longer follow-ups are required to confirm these findings and to examine the safety and long-term outcomes of trabeculectomy with OloGen.
Authors: Shivali A Menda; Eugene A Lowry; Travis C Porco; Robert L Stamper; Michel R Rubin; Ying Han Journal: Int Ophthalmol Date: 2014-06-12 Impact factor: 2.031