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Timothy Sullivan, Victor Cvintal, Wanda Deborah Hu, Feyzahan Ekici, Naryan Sabherwal, Michael Waisbourd, Michael J Pro, Marlene R Moster; Clinical Experience with Ahmed M4 Tube-Shunt in Various Types of Glaucoma: A Pilot Study. Invest. Ophthalmol. Vis. Sci. 2014;55(13):6133.
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To evaluate the safety and efficacy of the Ahmed Glaucoma Valve model M4 (AGV; New World Medical Inc., Rancho Cucamonga, CA). This device consists of a porous polythethiene shell, which was designed to reduce the fibrotic reaction around the plate. 1
Patients’ charts who underwent implantation of the AGV model M4 from 12/1/12 to 8/31/13 were reviewed. Primary outcome: intraocular pressure (IOP) reduction; Secondary outcome: number of glaucoma medications and number of reoperations related to surgical complications or glaucoma. Clinical parameters were collected pre-operatively and on day 1, week 1 and 1-, 3- and 6- months post-operatively.
Thirty-six eyes were included. Mean follow-up time was 136 ± 62 days. Preoperatively, subjects had a mean of 0.97 ± 1.0 prior glaucoma surgeries and a mean LogMAR visual acuity of 1.04 ± 0.89. Table 1 shows the mean IOP and number of glaucoma medications by pre- and post-operative visit. The percentage of IOP drop in day 1 and 3 month was 72% and 22% respectively. The average use of medications per patient was 2.9 ± 0.84 and 0.13 ± 0.43 before surgery and 3 months after, respectively. Thirty six percent of the patients had at least 1 complication; hyphema and shallow anterior chamber were the most prevalent early complications. Ten eyes underwent additional procedures to manage surgical complications. Four eyes needed reoperation for glaucoma 3 months post-operatively. No significant vision-threatening complications were recorded.
The AGV model M4 effectively reduced IOP during the first post-operative month. The IOP reduction at 1-month is comparable to published data. There was a trend toward higher IOP values after 3- and 6- months; however, this can be explained by a lower number of hypotensive drops used, compared to the previous report. Further studies are required to evaluate the long-term efficacy and safety of this device.
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