INtroducing
A New Class of Implant for Surgical Glaucoma
Welcome to the supraciliary space: welcome to the Intercil® Uveal Spacer. The Cilioscleral Inter-positioning Device (CID) that works with the natural physiology of the eye without needing to enter the Anterior Chamber. For glaucoma surgery that’s ab-externo, yet bleb free.1 Offering a promising safety profile, potent standalone IOP lowering in both POAG and PACG2. Your new glaucoma plan A, that won’t stop a plan B (or C). We’re conquering the space, soon it will be yours to use. Choose Intercil® and take glaucoma surgery to a different space.
Intercil® Uveal Spacer
Key Benefits¹ ²
AC Free: harnessing the potential of the supraciliary space, but without any anterior chamber cleft to give an outstanding safety profile
Powerful standalone IOP lowering in POAG and PACG without the need for a bleb, antimetabolites or the associated post-op demands
Procedural simplicity that doesn’t inhibit future treatment options
Intercil® Uveal Spacer
Looking at Existing Surgical Options Today
Working externally to the Anterior Chamber (Ab-Externo) usually means creating a bleb. If wanting to avoid a bleb this normally means going Ab-Interno – resulting in the need to work extensively inside the anterior chamber. This can cause turbulence inside the AC and therefore a risk of compromising Endothelial Cells – amongst other potential adverse effects**3. In contrast Intercil® offers a completely different proposition – avoiding a bleb AND avoiding the anterior chamber. This is achieved by targeting the natural uveo-scleral outflow using a unique external approach1.
**Any anterior segment intervention has an impact on the CEC anatomy and physiology. Implanting any foreign body in the form of devices into the anterior chamber will have additional impact on the long-term viability of the corneal endothelium.
Ref: Corneal endothelium and its reaction to anterior segment surgical interventions, Sathish Srinivasan, FRCSEd, FRCOphth, FACS, Ayr, Scotland, Downloaded from http://journals.lww.com/jcrs on 04/02/2024
Intercil® Uveal Spacer
The INTERCIL® Uveal
Spacer Concept
Uveoscleral outflow changes throughout life and in various syndromes associated with elevated IOP4. Uveoscleral outflow is also reduced with aging5. The ciliary muscle does restrict uveoscleral outflow. The driving force for the uveoscleral outflow is the difference in pressure between the anterior chamber and the suprachoroidal space6.
Independent references have suggested that changing the tone of the ciliary muscle may redistribute aqueous humour between the conventional and uveoscleral outflow routes6.
The Intercil® Uveal Spacer has therefore been precision engineered by Ciliatech to create a localised gap between the ciliary muscle and the sclera1.
This spacing may decrease the element of resistance to the passage of aqueous humour into this area, and may thereby re-establish the natural uveo-scleral flow to the choroidal circulation – leading to a physiological reduction of IOP1.
Advantages
Potential Advantages
of this Approach1
Endothelial Cell Loss (ECL) risk may be minimized by working completely outside the Anterior Chamber (AC). This may be additionally advantageous for patients with pre-existing corneal issues
No cleft needs to be created in the AC – this is likely to minimize the occurrence of intraoperative hyphemas and other intra-AC adverse events
It is not necessary for patients to have open angles for the procedure (unlike many trabecular procedures), therefore Intercil® can also be used in Primary Angle Closure Glaucoma (PACG) as well as Primary Open Angle Glaucoma (POAG). Intercil® is therefore ‘angle agnostic’ for Shaffer grades 1, 2, 3 and 4
Minimal conjunctival involvement, combined with utilisation of a drainage pathway that differs to the majority of other surgical procedures (trabecular or sub-conjunctival filtration) means that Intercil® is unlikely to preclude you from utilising the above surgical options further on in the course of a patients disease
No bleb = no antimetabolites = no extensive post operative follow up regimes
Endothelial Cell Loss (ECL) risk may be minimized by having no device placed in the Anterior Chamber (AC). This may be additionally advantageous for patients with pre-existing corneal issues
It is not necessary for patients to have open angles for the procedure (unlike many trabecular procedures), therefore Intercil® can also be used in Primary Angle Closure Glaucoma (PACG) as well as Primary Open Angle Glaucoma (POAG). Intercil® is therefore ‘angle agnostic’ for Shaffer grades 1, 2, 3 and 4
Minimal conjunctival involvement, combined with utilisation of a drainage pathway that differs to the majority of other surgical procedures (trabecular or sub-conjunctival filtration) means that Intercil® is unlikely to preclude you from utilising the above surgical options further on in the course of a patients disease
Ongoing Clinical Research
† Intercil is a surgically implantable medical device that is indicated in adult patients (18 years old and older) suffering from mild to moderate glaucoma. Intercil is intended for use only by trained ophthalmic surgeons. The device is not exempt from the usual risks of surgery.
1 Intercil® Instructions for Use IFU – EN, Ciliatech SAS, 2024
2 SAFARI-I, SAFARI-II & SAFARI-III Clinical Trials; Ciliatech SAS, Data on File, August 2024
3 Corneal endothelium and its reaction to anterior segment surgical interventions, Sathish Srinivasan, FRCSEd, FRCOphth, FACS, Ayr, Scotland, Downloaded from http://journals.lww.com/jcrs on 04/02/2024
4 Uveoscleral Outflow, Current understanding and methods of measurement. Carol B. Toris, PhD. glaucoma today, September/October 2013
5 Toris CB, Yablonski ME, Wang Y, Camras CB. Aqueous humor dynamics in the aging human eye. Am J Ophthalmol. 1999;127(4):407-412.
6 THE UVEOSCLERAL OUTFLOW ROUTES – SIV F. E. NILSSON, Uppsala, Sweden, Eye (1997) 11, 149-154 © 1997 Royal College of Ophthalmologists