To listen and learn – Orca Surgical credits surgeons who share insights with the company
For the Orca Surgical team, the goal is addressing unmet needs of ophthalmic surgery patients and surgeons – even when those needs aren’t obvious. The Epi Clear epikeratome, Orca’s first commercially available product, and the related Epi-Bowman’s Keratectomy (EBK™) procedure are a case in point.
The idea for EBK™ grew from Yariv Bar-On’s experience in a large laser refractive surgery centre. Results with advanced surface ablation were quite good. However, each of seven surgeons used a different approach to removing the corneal epithelium, requiring seven different treatment protocols.
So when Bar-On founded Orca five years ago, the challenge was to standardise epithelium removal. This could further improve refractive outcomes by increasing the procedure’s reproducibility, he reasoned.
EBK™ removes the corneal epithelium layer-by-layer down to Bowman’s layer in about 10 to 20 seconds. It consistently leaves Bowman’s layer undamaged and free of epithelial cell debris with a smooth, gradual transition to full-thickness epithelium at the periphery.
This creates an ideal bed for refractive surface ablation, said Bar-On, now CEO of Orca, based in Caesarea, Israel. EBK™ enhances precision and eliminates the need for separate protocols and nomograms for each surgeon to correct for variations in epithelium removal.
LESS PAIN, QUICKER RE-EPITHELIALISATION
Patient safety and simplicity of use were also top considerations in developing the Epi Clear device and EBK™. “We designed the procedure to minimise trauma for the cornea. When you have less trauma you have less pain,” explained Bar-On. (Shetty R, Nagaraja H, Pahuja NK, Jayaram T, Vohra V, Jayadev C: Safety and Efficacy of Epi-Bowman Keratectomy in Photorefractive Keratectomy and Corneal Collagen Cross-Linking: A Pilot Study. Curr Eye Res 2015:1-7)
The Epi Clear epikeratome accomplishes this with materials and design that gently remove the epithelium layer-by-layer, Bar-On said. It consists of a removable polymer tip with two nearly parallel peeling surfaces separated by a groove. The whole device is made of a biocompatible material specially designed to fit five holding positions. This single-use, sterilised device enables the surgeon maximum certainty for each treatment.
As the Epi Clear is drawn across the eye, the leading polymer edge creates a small fold in the outermost remaining epithelial layer, allowing the second edge to peel it off. The movement creates a vacuum in the groove between the edges, gently pulling epithelial cells free while capillary attraction pulls them up into the groove, Bar-On said.
Each pass removes a layer of cells until the acellular Bowman’s layer is reached, with the number of passes required varying by patient, Bar-On said. Then the device stops because it is not sharp. “It peels until you can visualise Bowman’s,” he explained.
With Bowman’s undamaged and a smooth epithelium edge, EBK™ is less painful and re-epithelialisation is quicker with less risk of haze – effects demonstrated in one published clinical trial (Shetty R et al. Curr Eye Res. 2016 May;41(5):623-9) and several papers and posters, Bar-On said.
EBK™’s gentleness makes it popular not just for refractive procedures on healthy eyes, but for epi-off corneal crosslinking and treatment of recurrent corneal erosions, Bar-On said. Because these procedures leave Bowman’s intact, the reduction in re-epithelialisation time EBK™ delivers is even greater than with surface ablation.
With more than one-third of laser refractive procedures using EBK™ in Poland, and market penetration increasing in Spain, Italy and the USA, EBK™ is rapidly establishing itself as the new corneal epithelium removal standard. Bar-On credits his colleagues at Orca, who shepherded Epi Clear through more than 100 prototypes over seven years of development, and have several other innovative designs in the pipeline.
“Based on worldwide clinical papers and data, by using EBK™, patients report less pain, faster recovery time and better visual acuity. Meanwhile, physicians report much more confidence in results, reproducibility, ease of procedure with a short learning curve, and patient satisfaction,” Bar-On added.
Most of all, Bar-On credits the many surgeons who generously share their insights. “We are not just developing something in the lab, we are physically in the clinic listening to our users’ needs. Medicine is based on observation, Orca is challenged to serve those needs.”
In a pilot study, keratoconus patients treated using the Athens Protocol had less pain and quicker regrowth of corneal epithelium in eyes where the epithelium was removed using Epi-Bowman’s Keratectomy (EBK™) than in fellow eyes using a standard mechanical scraper and 20 per cent alcohol solution, reported A John Kanellopoulos MD, of LaserVision Clinical and Research Institute, Athens, Greece, and New York University School of Medicine, USA.
The Athens Protocol combines surface ablation and corneal crosslinking (CXL) in treating keratoconus. EBK™ peels the epithelium layer-by-layer using Orca Surgical’s Epi Clear epikeratome, leaving Bowman’s layer intact with no cell debris and smooth margins to full-thickness epithelium.
All five study patients, ranging from 19 to 27 years old, reported less discomfort in the EBK™-treated eye, and complete re-epithelialisation one to two days earlier after surgery, Dr Kanellopoulos said. Less erythema and light sensitivity were reported in the EBK™ eyes as well, he added.
“These early data are compelling for the potential advantage this new technology holds for safer, faster re-epithelisation in surface ablation procedures compared to standard alcohol/mechanical epi-debridement,” Dr Kanellopoulos said.
Yariv Bar-On: firstname.lastname@example.org