E-PTFE (Gore-Tex^®) implant with or without low-dosage mitomycin-C as an adjuvant in penetrating glaucoma surgery: 2 year randomized clinical trial

Abstract

ABSTRACT.Purpose: To test the expanded polytetrafluoroethylene (ePTFE) as a new adjuvant in trabeculectomy. Methods: Consecutive glaucoma surgical inpatients were observed at the Department of Ophthalmology of Palermo University. Sixty patients (60 eyes) were randomly assigned to undergo trabeculectomy (T), trabeculectomy with mitomycin-C (TMMC), with ePTFE (TG) or with mitomycin-C and ePTFE (TGMMC). Postoperative visits were scheduled at 24 hr, 7 days, 1, 3, 6, 12, 18 and 24 months. Complete success and qualified success were assessed at two target intraocular pressure (IOP) levels -£21 and £17 mmHg -by Kaplan-Meier curves. Results: The postoperative IOP reduction was significant (P < 0.01) at the endpoint in all groups, with a mean IOP of 16.9 (±2.9), 16.2 (±2.7), 15.3 (±3.4) and 15.2 (±4.3) mmHg in T, TMMC, TG and TGMMC eyes, respectively. No intergroup difference was found at either IOP targets. The Kaplan-Meier curves relating to either the £21 mmHg or the £17 mmHg target IOP did not show significant intergroup differences for complete and qualified success rate. When ePTFE was used, a trend favouring the medium-term survival rate was noted. No adverse reaction to the ePTFE was present, and no membrane extrusion or conjuctival erosion were noted in any cases. Hypotony was significantly more frequent (P = 0.035) in groups without ePTFE. Moreover, the late MMC-related complications were more frequent when MMC was applied. Conclusion: Expanded polytetrafluoroethylene implant in trabeculectomy is well tolerated and could act as a filtration modulating device. Therefore, it is useful in reducing early hypotony-related complications and contributes to attaining medium-term IOP control that is comparable to the low-dosage MMC.

The effect of deep sclerectomy on intraocular pressure of normal‐tension glaucoma patients: 1‐year results

“…2006). The use of an expanded polytetrafluoroethylene implant may reduce the frequency of early hypotony with trabeculectomy (Cillino et al. 2008).…”

Prevention of Ocular Tenon Adhesion to Sclera by a PDMAA Polymer to Improve Results after Glaucoma Surgery

“…On the other hand, separating agents such as hyaluronate hydrogel, biodegradable collagen, or expanded polytetrafluoroethylene coatings can be used to separate the scleral flap from the lower part of the sclera to prevent scarring. Approaches that use a separating agent to prevent scarring, however, showed inconsistent results concerning the surgical outcome and are therefore far away from being used in a clinical routine …”

A novel bilayered expanded polytetrafluoroethylene glaucoma implant creates a permeable thin capsule independent of aqueous humor exposure

“…ePTFE has been evaluated previously in glaucoma surgery. [33][34][35][36][37][38][39] The Ahmed implant was modified with an outer ePTFE membrane to create the PRIME-Ahmed, which showed increased resistance to fluid outflow in vitro, but created a thinner capsule in rabbit eyes when compared to unmodified Ahmed implants. 34,36 Of note, blebs associated with the PRIME-Ahmed showed a greater degree of vascularization, collagen disorganization, and chronic inflammation compare to control implants; these features were not noted in our histopathological exams.…”