Abstract
To determine the efficacy and safety of the Ologen collagen matrix adjunctive to Ahmed valve surgery. A randomized prospective multicentre clinical trial involving 58 patients that were followed for one year. Conventional surgery with Ahmed valve was performed in 31 eyes (Control group/CG) and in 27 Ologen (Ologen group/OG) was placed over the valve’s plate. Baseline data: age, corneal thickness, intraocular pressure(IOP) and antiglaucoma medications.Postoperative data (days 1, 7 and months 1, 3, 6 and 12): IOP, antiglaucoma medications, visual acuity and complications were recorded. Frequency of hypertensive phase, complete and qualified success and survival rate were studied. No differences were found between CG and OG in the baseline data. The only difference between groups was a significantly lower IOP at day 1. No other differences were found in the follow-up between groups. Hypertensive phase (56%CG and 55%OG, p = 0,947), complete success 28,6%CG and 30,4%OG (p = 0,88) and qualified success 96,4% and 95,9%(p = 0,794). Survival rates at 1 year were 76,7%(CG) and 69,2%(OG)(p = 0,531). 38,7% of patients in the CG suffered some complication during follow-up and 61,5% in OG(p = 0,086). Ologen does not increase safety or efficacy in Ahmed valve surgery at one-year follow-up. This is the first study that shows no benefit of Ologen adjunctive to this surgery.
Highlights
Glaucoma drainage devices (GDD) are commonly used in glaucoma surgery specially after the TVT (Tube versus Trabeculectomy) study that showed a higher success rate and lower rate of re-operations of tube shunt surgery (Baerveldt 350 mm2) compared to trabeculectomy with MMC at 5 years follow-up[1,2]
The number of glaucoma medications increased during the 12 months but never reached the number of previous treatments and no differences were found between groups (Fig. 2)
Our study showed that the use of Ologen in Ahmed Glaucoma Valve (AGV) surgery did not offer better intraocular pressure (IOP) control, less need of antiglaucoma medications or higher success rates than conventional surgery after one-year follow-up
Summary
Glaucoma drainage devices (GDD) are commonly used in glaucoma surgery specially after the TVT (Tube versus Trabeculectomy) study that showed a higher success rate and lower rate of re-operations of tube shunt surgery (Baerveldt 350 mm2) compared to trabeculectomy with MMC (mitomycin-C) at 5 years follow-up[1,2]. A main limitation of the Ahmed Glaucoma Valve (AGV; New World Medical, Inc., Rancho Cucamonga, CA) in comparison with other devices is a higher incidence of hypertensive phase. This occurs in 40–80%7,8 of patients and is thought to be due to bleb fibrosis and inflammation. To the best of our knowledge this is the first randomized prospective multicentre clinical trial to evaluate Ologen with AGV implantation as compared with standard surgery, with the longest follow-up, and in Caucasian population
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
