Using a simple Ab-Externo surgical procedure, the implant is placed in between the ciliary body and sclera without needing to open the anterior chamber, or create a cyclodialysis cleft1.
Intercil®️ is a non-resorbable, one-piece 26% hydrophilic acrylic implant. This material widely used in the manufacturing of intra-ocular lenses, which ensures long-term biocompatibility (‘uveocompatibility’)
The implant consists of a precision engineered plate measuring 7mm x 3.4mm x 0.6mm which is trapezoidal in shape. Fairly uniquely and unlike a number of other devices used in glaucoma surgery, Intercil®️ is not a tube
The device has been designed with grooves and corrugations to maximise the outflow from the anterior chamber to the suprachoroidal space
Ciliatech have been investing in the SAFARI (SuprAciliary Filtration Alone Reduces IOP) Clinical Trial Programme since 2020. These are a combination of multicenter, prospective, nonrandomized trials. The trials in this programme are so far reporting as far as 3 years of follow up and are seeking to validate the hypothesis that Supraciliary Filtration Alone Reduces IOP without opening the anterior chamber and without disinserting the iris root to create a cleft2.
Ciliatech plans to embark upon additional studies in order to continue supporting the device with further scientific validation
In the SAFARI 1&2 studies, the first version of Intercil® has been implanted in 41 patients.
After refining the device design Ciliatech have since trialled Intercil® in an additional 57 patients in the SAFARI-3 study. In this trial patients with both Primary Open Angle Glaucoma (POAG) and Primary Angle Closure Glaucoma (PACG) were tested – overall results were remarkably similar between groups.
“A CID surgery is very simple, safe and short to perform. It is minimally invasive, very gentle and the learning curve is fast. But most importantly, the anterior chamber is preserved, so that the cornea is not exposed and the eye is very calm in the post-op period, with no bleb and no pain for the patient. And this without saying that the IOP results are also very good and sustained in the long run.”
Dr L. Voskanyan MD PhD
Head of Glaucoma department, S.V. Malayan’s Eye Center
Chief of Ophthalmology at Yerevan State Medical university
Intercil® is CE certified by the notified body Kiwa Italia, CE 0476, as an implantable medical device (Class IIb). Intercil® is available for sale in European Union and UK.
During this period Ciliatech plans to continue follow up of the current studies beyond the existing 3-year time points, in addition to embarking upon additional new multi-centre studies around the world in order to continue supporting the device with further scientific validation.
Contra-indication:
INTERCIL® should not be used in a case of known hypersensitivity or individual allergy to one or more of the components.
INTERCIL® should not be used in an eye with traumatic, malignant, uveitic or neovascular glaucoma.
No clinical experience was collected concerning the use of INTERCIL® in children, or pregnant or nursing women.
† 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 Uveoscleral Outflow, Current understanding and methods of measurement. Carol B. Toris, PhD. glaucoma today, September/October 2013
4 Toris CB, Yablonski ME, Wang Y, Camras CB. Aqueous humor dynamics in the aging human eye. Am J Ophthalmol. 1999;127(4):407-412
5 Hydrostatic Pressure of the Suprachoroidal Space Kozuyuki Emi, Jonathan E. Pederson, and Carol B. Toris Investigative Ophthalmology & Visual Science, Vol. 30, No. 2, February 1989 Association for Research in Vision and Ophthalmology
6 THE UVEOSCLERAL OUTFLOW ROUTES – SIV F. E. NILSSON, Uppsala, Sweden, Eye (1997) 11, 149-154 © 1997 Royal College of Ophthalmologists
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