A new glaucoma drainage implant with the use of Polytetrafluoroethylene (PTFE). A pilot study

Purpose: To investigate the implantation of Polytetrafluoroethylene (PTFE) as a glaucoma drainage device. Methods: This study has been done in two steps. First, the constructed implants have been used in 4 rabbits and the histopathologic response was evaluated. In the second step, the implants were used in the 6 eyes of 6 patients with end-stage glaucoma with uncontrolled IOP and poor visual acuity. The tube was made of two-layer of PTFE membrane measuring 8 * 6 mm with a thickness of 1.8 mm and a silicone tube. The rabbits and the human eyes underwent surgical implantation of the tube in the anterior chamber. The histopathologic evaluation was done using H&E staining. Visual acuity, intraocular pressure and the number of glaucoma medications were assessed before and after the surgery. Results: In the histopathologic evaluation, subconjunctival polarizing fibers of a synthetic mesh infiltrated by fibrovascular septa was seen. A granulomatous inflammatory reaction composed of histiocytes, lymphocytes, and multinucleated giant cells were seen around and between the synthetic bundles. The average age of patients was 63 ± 5.5 years. The mean IOP reached from 36.6 ± 5.7 mmHg at baseline to 16.2 ± 8.9 mmHg at the final follow-up. Patients were followed for an average of 6.6 ± 4.5 months. One patient found hypotony refractory to medical and surgical treatment, which led to implant removal. One patient had uncontrolled IOP and finally led to phthisis bulbi following slow CPC. The remaining four eyes did well during the follow-up. Conclusion: The use of PTFE as a new polymer in tube shunt construction was reported. Larger studies, modification of the PTFE membranes like changing the porosity amount, and size of PTFE membranes might result in different conclusions.