A newly designed glaucoma drainage implant made of poly(styrene-b-isobutylene-b-styrene): biocompatibility and function in normal rabbit eyes.

OBJECTIVE To report clinical evaluation, flow patency, and histopathological findings of a novel glaucoma drainage implant (GDI) made of poly(styrene-b-isobutylene-b-styrene) (SIBS) in rabbits. METHODS In 16 normal eyes, the proximal end of the SIBS GDI was inserted into the anterior chamber while the distal end was placed in the subconjunctival space. A control group underwent implantation of a similarly designed silicone GDI. Slitlamp follow-up and intraocular pressure measurements were recorded. Flow patency was evaluated by injecting 0.01% fluorescein into the anterior chamber. Immunostaining against collagen IV, macrophages, and alpha smooth muscle actin was performed. RESULTS Slitlamp examination suggested adequate biocompatibility. A low and diffuse bleb was observed in the SIBS group. All SIBS tubes were patent 6 months after insertion. Immunostaining demonstrated noncontinuous collagen deposition. No macrophages or myofibroblasts were visible around the SIBS tubes. In contrast, silicone induced collagen deposition and myofibroblast differentiation. CONCLUSION This new GDI is clinically biocompatible in the rabbit and maintained 100% patency at 6 months. A remarkable difference was the absence of myofibroblasts in the surrounding tissue in the SIBS group. CLINICAL RELEVANCE This novel GDI made of SIBS would prevent the feared complication of hypotony and will decrease the amount of subconjunctival fibrosis.

[1]  A. Molteno,et al.  Otago Glaucoma Surgery Outcome Study: factors controlling capsule fibrosis around Molteno implants with histopathological correlation. , 2003, Ophthalmology.

[2]  C. Geankoplis,et al.  Transport processes and separation process principles : (includes unit operations) , 2003 .

[3]  A. Molteno New implant for drainage in glaucoma. Animal trial. , 1969, The British journal of ophthalmology.

[4]  Gregg W. Stone,et al.  A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease , 2004 .

[5]  Leonard Pinchuk,et al.  Ocular Biocompatibility of QuatromerTM (polystyrene–polyisobutylene triblock polymers) for Glaucoma Implants , 2004 .

[6]  Molteno Ac The optimal design of drainage implants for glaucoma. , 1981 .

[7]  W. Feuer,et al.  Corneal graft survival and intraocular pressure control after penetrating keratoplasty and glaucoma drainage device implantation. , 2001, Ophthalmology.

[8]  A. Molteno New implant for drainage in glaucoma. Animal trial. , 1969, The British journal of ophthalmology.

[9]  P Herbison,et al.  Otago glaucoma surgery outcome study , 1999 .

[10]  C. Crosson,et al.  Effects of daunomycin implants on filtering surgery outcomes in rabbits. , 1998, Current eye research.

[11]  R. Bock Subconjunctival drainage of the anterior chamber by a glass seton. , 1950, American journal of ophthalmology.

[12]  J. Parel,et al.  [Artificial trabeculum (MESH). Clinical and histological study in the rabbit]. , 1998, Journal francais d'ophtalmologie.

[13]  C. Burgoyne,et al.  Biocompatibility response to modified Baerveldt glaucoma drains. , 1998, Journal of biomedical materials research.

[14]  J. Kennedy,et al.  Designed Polymers by Carbocationic Macromolecular Engineering: Theory and Practice , 1992 .

[15]  C. Foster,et al.  Management of uveitic glaucoma with Ahmed glaucoma valve implantation. , 1999, Ophthalmology.

[16]  Y. Epstein,et al.  Biocompatibility of the Ex-PRESS Miniature Glaucoma Drainage Implant , 2003, Journal of glaucoma.

[17]  R. Ayyala,et al.  Comparison of different biomaterials for glaucoma drainage devices: part 2. , 1999, Archives of ophthalmology.

[18]  D. Minckler,et al.  Which is better? One or two? A randomized clinical trial of single-plate versus double-plate Molteno implantation for glaucomas in aphakia and pseudophakia. , 1992, Ophthalmology.

[19]  F. Fantes,et al.  Surgical management of patients with combined glaucoma and corneal transplant surgery. , 2003, Current opinion in ophthalmology.

[20]  R. Bartholomew,et al.  Implants for draining neovascular glaucoma. , 1977, The British journal of ophthalmology.

[21]  John G. Mclaurin An Operation for Glaucoma , 1935 .

[22]  A. Stanworth Conjunctival fibrosis after filtration operations. , 1958, Transactions of the ophthalmological societies of the United Kingdom.

[23]  D. Richards,et al.  Clinical experience with the Baerveldt glaucoma drainage implant. , 1995, Ophthalmology.

[24]  D. Minckler,et al.  Initial clinical experience with the baerveldt implant in complicated glaucomas. , 1994, Ophthalmology.

[25]  M. Helmus,et al.  Physical characterization of controlled release of paclitaxel from the TAXUS Express2 drug-eluting stent. , 2004, Journal of biomedical materials research. Part A.

[26]  Gregg W Stone,et al.  One-Year Clinical Results With the Slow-Release, Polymer-Based, Paclitaxel-Eluting TAXUS Stent: The TAXUS-IV Trial , 2004, Circulation.

[27]  J. Stefánsson An Operation for Glaucoma , 1925 .

[28]  A. Coleman,et al.  Initial clinical experience with the Ahmed Glaucoma Valve implant. , 1995, American journal of ophthalmology.

[29]  R. P. Mills,et al.  Long-term survival of Molteno glaucoma drainage devices. , 1996, Ophthalmology.

[30]  T. Krupin,et al.  Valve implants in filtering surgery. , 1976, American journal of ophthalmology.

[31]  Christopher C. Wilcox,et al.  Performance of a New, Low‐volume, High‐Surface Area Aqueous Shunt in Normal Rabbit Eyes , 2000, Journal of glaucoma.

[32]  A. Molteno,et al.  Long tube implants in the management of glaucoma. , 1976, South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde.

[33]  D. Minckler,et al.  In vitro and in vivo flow characteristics of glaucoma drainage implants. , 1995, Ophthalmology.

[34]  J. Parel,et al.  Synthetic meshwork implant for glaucoma filtering surgery: effect of adjunct heparin and sodium hyaluronate in rabbits. , 1998, Ophthalmic surgery and lasers.

[35]  A. Molteno,et al.  Surgical technique for advanced juvenile glaucoma. , 1984, Archives of ophthalmology.

[36]  H. Gelender,et al.  The use of Molteno implant and anterior chamber tube shunt to encircling band for the treatment of glaucoma in keratoplasty patients. , 1990, Ophthalmology.

[37]  C. Burgoyne,et al.  Slow release of the antimetabolite 5-fluorouracil (5-FU) from modified Baerveldt glaucoma drains to prolong drain function. , 2001, Biomaterials.