New glaucoma treatment development: the cilioscleral technique

At the World Glaucoma Congress (WGC) in Rome, Italy this summer, Ciliatech presented preliminary results of the second 2-year postoperative clinical trial (SAFARI Ⅱ) on its Cilioscleral Interposition Device (CID). The device, a 26% hydrophilic acrylic implant, is designed to lower intraocular pressure without entering the anterior chamber and without bleb (Figure 1).

In the poster presented at the WGC, study results showed a statistically and clinically significant reduction in IOP.¹ In patients with primary open-angle glaucoma (POAG) who received 1 or 2 implants, IOP reduced by 39% at 24 months. Notably, no statistical difference was observed between patients who received 1 or 2 implants, which suggests a single device is effective in decreasing IOP (Figures 2, 3, 4). Ophthalmology Times Europe spoke to Dr Philippe Sourdille the pioneer behind Ciliatech’s CID implant and the cilioscleral technique.

As the cofounder of Ciliatech, Sourdille has spent years developing the CID and spoke to its unique role in the microinvasive glaucoma surgery (MIGS) space. “We want to avoid any risk related to corneal damage, which can happen with devices introduced in the anterior chamber,” Dr Sourdille said. “We also want to avoid any formation of subconjunctival blood, which means a lot of follow-up and a lot of potential complications.” That includes postoperative medications, he added, noting that the burden of continually managing glaucoma with medication diminishes quality of life for many patients.

Dr Sourdille explained the process of the procedure, during which surgeons use a distance-operated instrument to slide the implant into place (Figure 5). “You do not see the implantation of the device,” Dr Sourdille explained, but this does not present a problem. “If you have separated the sclera from the ciliary body, it slides very easily.” He said the procedure is fairly easy to learn and to teach. “There is no real learning curve,” he said. The key is “to be confident in your [ciliioscleral] separation...and slide without visual control.” Future studies the team is conducting in Spain will have optical coherence tomography (OCT)-mounted microscopes which will allow surgeons to see the implant through the sclera. But, Dr Sourdille noted, “It’s not mandatory to have such a sophisticated system to do the operation.”

At the WGC, Ciliatech’s poster detailed the capabilities of the CID and its patient outcomes.¹ At baseline, all patients in the study had prescriptions for 1 to 4 hypotensive medications to manage glaucoma. After 24 months with the CID, 85% of patients no longer required their prescriptions. Also, during the study, there were no reports of complications or adverse events (including angle modification and device movement).

Following the congress, Ophthalmology Times Europe spoke to Dr Lilit Voskanyan, head of the Glaucoma Department in Ophthalmology at the Malayan Center, Yerevan, Armenia. Dr Voskanyan detailed reactions to the poster presentation. The lack of adverse effects or need for postoperative modification were a major source of interest at the meeting.

“The Ciliatech implants have almost zero complications, and zero serious complications,” said Dr Voskanyan, referring to the outcomes of the 2-year study. The 10-minute procedure takes longer than some MIGS procedures, she noted, but is worth the time to avoid postoperative complications.

Dr Voskanyan fielded questions about the procedure, including potential for adverse effects. “This surgery does not work inside of the eye, which brings inflammation and infectious growth,” she explained. The first month following implantation is a crucial period to monitor progress and complications. “When done successfully, the surgery begins to help [lower IOP] within the first month, then it helps for a long, long time,” Dr Voskanyan said. Both she and Dr Sourdille reported patients with the CID saw IOP continually reduced over time.

As Ciliatech conducts long-term research with the new implant, Dr Voskanyan said she hopes the novel procedure becomes a common approach to glaucoma treatment. She said most practitioners experience a learning curve of 7 to 10 surgeries. “It’s very easy to perform,” she said. “The main thing is to make the right measurements, and know the steps exactly as they should be done.”

Philippe Sourdille, MD, is the cofounder and medical director of Ciliatech. He was chairman of the Clinique Sourdille for over 20 years, and is a former president of the European Society of Cataract and Refractive Surgeons.

Lilit Voskanyan,MD, PhD, is the investigator for Ciliatech’s SAFARI clinical studies. She is head of the Glaucoma Department in Ophthalmology at the Malayan Center in Yerevan, Armenia.

Reference

1. Voskanyan L, Papoyan V, Sourdille P, Benoit O, Miroyan H. Supraciliary drainage without entering the anterior chamber and without bleb: 24 months follow up results. Poster presented at World Glaucoma Congress; June 2023; Rome, Italy.