Medical Devices: Evidence and Research (Jul 2020)
Comparison of Silicone- and Porous-Plate Ahmed Glaucoma Valves
Abstract
Tina M Roa,1 Peter A Netland,1 Vital P Costa,2 Steven R Sarkisian Jr,3 Lama A Al-Aswad,4 Marlene R Moster,5 Iqbal IK Ahmed6 1Department of Ophthalmology, University of Virginia School of Medicine, Charlottesville, VA 22908, USA; 2Department of Ophthalmology, University of Campinas, Campinas, Brazil; 3Oklahoma Eye Surgeons, PLLC, Oklahoma City, OK 73112, USA; 4Department of Ophthalmology, NYU Grossman School of Medicine, NYU Langone Health, New York, NY 10017, USA; 5Glaucoma Service, Wills Eye Hospital, Philadelphia, PA 19107, USA; 6Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, CanadaCorrespondence: Peter A NetlandUniversity of Virginia School of Medicine, PO Box 800715, Charlottesville, VA 22908, USATel +1 434 982-1086Email [email protected]: Our aim was to evaluate and compare the clinical outcomes after implantation of the silicone-plate (model FP7) and porous polyethylene-plate (model M4) Ahmed Glaucoma Valves.Patients and Methods: This was a prospective, multicenter, comparative series. A total of 52 eyes (52 patients) were treated with either the silicone or porous plate Ahmed Glaucoma Valve implant. Hypertensive phase was defined as intraocular pressure > 21 mmHg during the first 3 months postoperatively. Success was defined as 5 mmHg ≤intraocular pressure ≤ 21 mmHg (with or without additional glaucoma medications), without loss of light perception and without additional glaucoma procedures. Patients were monitored for 1 year after surgery.Results: The pre-operative intraocular pressure was 29.9 ± 6.6 mmHg and 33.8 ± 10.5 in the silicone-plate and porous-plate groups, respectively (P = 0.118). At 12 months after surgery, the mean intraocular pressure was 13.6 ± 4.7 mmHg in the silicone-plate group and 17.9 ± 10.9 mmHg in the porous-plate group (P = 0.141). The mean number of glaucoma medications at 12 months was 1.64 ± 1.40 mmHg and 1.89 ± 1.54 mmHg in the silicone- and porous-plate groups, respectively (P = 0.605). Hypertensive phase was not significantly different in the two groups (50.0% of the silicone-plate and 57.7% of the porous-plate groups, P = 0.578). At 12 months after surgery, the percent success for the silicone-plate and porous-plate groups was 88.5% and 53.8%, respectively (P = 0.005). Complications were similar in the two groups.Conclusion: The porous-plate Ahmed Glaucoma Valve showed similar average intraocular pressure reduction compared with the silicone-plate model. At 12 months after surgery, there was a significantly lower success rate in the porous-plate compared with the silicone-plate group.Keywords: Ahmed Glaucoma Valve, model FP7, model M4, glaucoma drainage implant, porous polyethylene, Medpor