Ab interno trabeculectomy: development of a novel device (Trabectome) and surgery for open-angle glaucoma.

PURPOSE: To design an instrument to selectively remove trabecular meshwork and Schlemm's canal inner wall (SCIW), and demonstrate its effectiveness by histologic analysis of treated cadaveric human tissue. METHODS: The design parameters of the instrument were the ability to permanently remove a segment of trabecular meshwork and Schlemm's canal inner wall without causing damage to surrounding tissue, and to allow use with standard anterior segment surgical techniques and equipment via an ab interno approach. Treatment was applied to 20 segments of human corneoscleral rims. The treated areas were examined using a confocal microscope and compared with matching areas in untreated controls and simulated goniotomy. RESULTS: The resultant instrument system surgically removes the trabecular meshwork and Schlemm's canal inner wall from an anterior chamber approach. It consists of a disposable surgical handpiece with irrigation, aspiration, and electrocautery to focally ablate the target tissues. The attached console includes a high-frequency (550 KHz) electrosurgical generator and irrigation/aspiration controlled by a foot pedal. Histologic examination of specimens treated with the Trabectome displayed disruption of the trabecular meshwork and Schlemm's canal inner wall without damage to surrounding structures. The specimens treated by simulated goniotomy displayed significant damage to the outer wall of Schlemm's canal and the surrounding sclera. The controls showed no disruption or damage to any tissues. CONCLUSIONS: The Trabectome system is designed for performing trabeculectomy via an ab interno approach. It successfully removed sections of trabecular meshwork and Schlemm's canal inner wall with less injury to the adjacent tissue compared with goniotomy knife in vitro. Theoretically, this procedure should provide direct access of aqueous humor to Schlemm's canal.