Supra Ciliary Drainage Without Entering The Anterior Chamber And Without Bleb: A Totally New Glaucoma Surgery Concept

Published 2022 - 40th Congress of the ESCRS

Reference: PP15.10 | Type: Free paper | DOI: 10.82333/x3yn-nc70

Authors: Lilit Voskanyan* ¹ , Vahan Papoyan ² , Astghik Ghazaryan ² , Hovsep Miroyan ²

¹Glaucoma Department,S.V. Malayan's eye centre,Yerevan,Armenia, ²Glaucoma department,S.V. Malayan's Eye Center,Yerevan,Armenia

Purpose

Enhancing uveo-scleral outflow to lower intra ocular pressure (IOP) by interposing an implant between the sclera and the ciliary body without entering the anterior chamber nor creating any subconjunctival filtration

Setting

S.V. Malayan's Eye Center

Methods

42 Caucasian patients, 62±9 years were enrolled in a 1st-in-human clinical study, followed at D1, D7, D30, M3, M6, M12

Inclusion criteria: POAG Shaffer 3 & 4 with medically uncontrolled IOP > 21 mmHg, naive from prior glaucoma surgery, glaucoma standalone surgery only. No wash out. Prostaglandins mandatory 30d post-op. IOP, comedications and safety parameters were collected at each time point

1st group: n=20, operated from Dec. 2020 to Jan. 2021 with 1 implant

2nd group: n=22 operated from Apr. to May 2021 with 2 implants sutured one over the other

A 26% hydrophilic acrylic implant, 6*4*0.2 mm, is inserted 2mm behind limbus in the supraciliary space through 2 scleral incisions. Anterior chamber is untouched. Incisions are sutured watertight

Results

Overall safety appeared very good, no patient needed adjunctive treatment or new surgery up to M12

Group 1

Baseline IOP was 23.7±2.5 mmHg w 2.0±0.6 meds, then 16.0±5.6 w 0.2±0.4 meds at M3 (n=19), 15.7±2.4 w 0.2±0.5 meds at M6 (n=18), 16.1±2.5 w 0.2±0.5 meds at M12 (n=18) showing IOP drop of 32%, 34% and 32%, and meds drop of 92%, 89% and 89% at M3, M6 and M12 resp.

Group 2

Baseline IOP was 25.8±4.5 mmHg w 1.6±0.6 meds, then 17.5±6.0 w 0.05±0.2 meds at M3 (n=19), 16.6±2.8 w 0.3±0.6 meds at M6 (n=17) showing IOP drop of 32% and 36%, and meds drop of 97% and 84% at M3 and M6 resp

UBM exams shown ideal placement at the angle, w/o postop movement along FU. No subconjunctival filtration was detected, gonioscopy confirmed absence of angle modification

Conclusions

To the best of our knowledge this is the first time a device can significantly lower the IOP without entering the anterior chamber nor creating some subconjunctival filtration. 88% of Group 1 patients are mdeication free at M12, and 86% of Group 2 at M6.

Surgical enhancement of uveoscleral outflow though physiological pathways seems to be a very promising approach.