3 Years Outcomes Of A Novel Cilio-Scleral Interposition Device (Cid Sv13): Managing Iop Without Entering The Anterior Chamber

To assess the effect of a novel cilio-scleral interposition (CID) device inserted ab externo, without subconjunctival filtration nor anterior chamber (AC) infraction, on the IOP and postoperative glaucoma medications (meds) rate of patients with primary open-angle glaucoma (POAG).

First-in-human clinical study conducted in S.V. Malayan eye Centre, Yerevan, Armenia from December 2020 to May 2021.

The 25% hydrophilic acrylic, 6 by 4mm, 200µm thick, CID SV13 implant was inserted 2 mm behind the limbus through 2 scleral incisions, separating the sclera and ciliary body without entering the AC. Scleral incisions are watertight closed after implant positioning. Group 1 received 1 implant and group 2 received 2 implants sutured together. Inclusion criteria included POAG Shaffer 3 and 4 with medically uncontrolled IOP, naive from any prior glaucoma incisional surgery or SLT more than 6 months, expected for glaucoma standalone surgery. No washout was performed. Prostaglandins were mandatory per protocol for 30d post-operatively. IOP, concomitant pharmacological treatments and other clinical and safety parameters were collected up to 36 M.

42 Caucasian patients, 62 ± 9 years, 23M 19F were included.

In group 1 (ITT n=20) baseline IOP was 23.7 ± 2.6 mmHg with 2.2 ± 0.8 meds, 15.4 ± 8.3 mmHg with 0.3 ± 1.0 meds at M6 (n=18), 15.4 ± 2.7 mmHg w 0.3 ± 0.5 meds at M24 (n=16) and 15.5 ± 1.2 mmHg with 0.5 ± 0.6 meds at M36 showing IOP / meds decrease of resp. 35, 35 and 34%, and  85, 86 and 77% at each timepoint.

In group 2 (ITT n=22), baseline IOP was 25.8±4.6 mmHg with 1.8 ± 0.6 meds, 18.2 ± 6.4 mmHg with 0.4 ± 0.8 meds at M6 (n=17) and 15.8 ± 5.0 mmHg with 0.7 ± 1.0 meds at M24 (n=17) showing IOP / meds decrease of resp 29%, 40%, and 80, 61% at M6 and M24.

At 36M: no adjunctive treatment, no new incisional surgery, no bleb, no implant displacement nor encapsulation was observed.

These results suggest that the CID device can significantly lower IOP and postoperative medication rate, without penetrating the AC and with no significant adverse event or complication up to M36. IOP decreases to mid-tens since D1 and remains stable up to M36, with limited use of medications.

This is the 1st time it is shown that penetrating the AC with an implant is NOT necessary to achieve low IOP / med scores. This improves patient safety as hyphema or AC inflammation are very limited. Corneal issues like ECL, erosion, decompensation are not possible by concept.

This device could represent a safe and effective treatment option for patients with POAG and could reduce the clinical and economic burden associated with glaucoma medications.