The OptiShuntV1 is a proof of concept device designed to evaluate the safety, feasibility, and efficacy of oculosubarachnoid shunting.
The device is manufactured using world-class silicone micro moulding techniques according to ISO13485 guidelines. First in man clinical trial of the device is currently underway in the GOSSIP study being conducted at Groote Schuur tertiary academic Hospital, the home of the world’s first heart transplant.
GOSSIP study results
The Glaucoma treatment by OculoSubarachnoid Shunt Insertion Pilot (GOSSIP) study is an early feasibility study evaluating the safety and feasibility of oculosubarachnoid shunting and the performance of the OptiShuntV1 device. The study is conducted according to GCP and ISO14155 guidelines and aims to recruit 15 patients with severe, end-stage glaucoma refractory to medical therapy. Due to the coronavirus pandemic, recruitment was temporarily halted after the 8th patient.
3-month trial results demonstrate that oculosubarachnoid shunting is safe and highly effective in lowering IOP and the number of medications used by patients.
74% reduction in mean IOP
41mmHg → 11mmHg
The Mean IOP prior to OptiShuntV1 insertion was 41 mmHg on an average of 3 medications. At 3-months post insertion, the Mean IOP was reduced by 74% to 11mmHg with all patients reaching a target IOP of <18mmHg on an average of 1 medication. No severe, unexpected, or intra-operative adverse events occurred and areas for improved surgical technique and device design were successfully identified
The OptiShunt is an oculosubarachnoid glaucoma device (OGD) which is inserted via the ab-externo pathway.
The device creates an open shunt communication between the ocular anterior chamber and the retrolaminar subarachnoid space. By making use of this naturally occurring fluid reservoir, the OptiShunt is able to provide self-regulating, highly effective intraocular pressure (IOP) control without the complications associated with bleb formation.
The OptiShuntV2 is the follow-on device which incorporates design optimisation changes identified during the GOSSIP study.
The device includes a two-part construction and a modified shunt insertion device to make the device simpler, safer, and even more effective. The OptiShuntV2 is planned for implementation in the GOSSIP study phase 2, starting in 2021.