Efficacy of Ologen matrix implant in Ahmed Glaucoma Valve Implantation

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.

Ologen augmentation of Ahmed glaucoma drainage devices in pediatric glaucomas

“…12 Months 0 (6 Eyes) p = 0.0008 2.1 ± 1.4 (9 Eyes) p = 0.7 p = 0.002 Final 0.2 ± 0.4 (6 Eyes) p = 0.001 2.0 ± 1.0 (5 Eyes) p = 0.6 p = 0.003 of GDD implantation has predominantly fallen out of favor as studies have either shown an increase in bleb leaks and complications secondary to hypotony or no significant difference in IOP or number of glaucoma medications [22]. More recently, studies have utilized Ologen in conjunction with AGV implantation in adult glaucomas [13,14,23].…”

“…To date, three studies have reported the use of Ologen as an adjuvant for AGVs in adults [13,14,23]. The first showed that increased AGV success correlated with the thickness of the Ologen disc.…”

“…This late-onset requirement for glaucoma medications may be due to the biodegradation of the Ologen implant [14]. The third study, a randomized prospective clinical trial, reported no difference in incidence of hypertensive phase or rate of AGV success at 1-year follow-up [23]. Importantly, these studies excluded children, although the study by Kim et al included two patients with a history of primary congenital glaucoma who underwent AGV implantation after the age of 18 years [14].…”

Efficacy of biodegradable collagen matrix (Ologen® CM) in augmenting the success rate of Ahmed glaucoma valve implantation in canine glaucoma

“…The biodegradable collagen matrix is placed over the drainage device implant, and influences healing by causing fibroblasts and myofibroblasts to ingress into the pores and secrete connective tissue, thus forming a loose matrix 9 . Although the safety and efficacy of ologen during AGV implantation for human ophthalmological conditions remains controversial, we hypothesized that ologen may decrease the complications associated with MMC and 5‐FU among dogs 10,11 . We think that this surgical method can increase the surgical success rate and reduce the number of anti‐glaucoma medications required after operation 10,11 .…”

“…Although the safety and efficacy of ologen during AGV implantation for human ophthalmological conditions remains controversial, we hypothesized that ologen may decrease the complications associated with MMC and 5‐FU among dogs 10,11 . We think that this surgical method can increase the surgical success rate and reduce the number of anti‐glaucoma medications required after operation 10,11 . Although numerous studies have investigated the clinical efficacy of ologen for AGV surgery in humans, to our knowledge, no studies have reported cases of AGV implantation surgery using ologen for treating canine glaucoma.…”