• How Viscoelastics Gained Ophthalmic Acceptance

    Written By: David Miller, MD

    In the mid 1970s there was strong opposition to IOL implantation. Some even said, “We take foreign bodies out of the eye, we don’t put them in.” The opposition had some legitimacy: at that time, the incidence of post-op corneal edema was very high. Indeed, the great Spanish ophthalmologist Joaquin Barraquer, MD stopped implanting IOLs altogether.

    Viscoelastics would change that.

    The first player in the viscoelastic story was a Hungarian laboratory scientist, by the name of Endre Balazs. He had come to Boston in the 1960s to develop an artificial vitreous using hyaluronic acid, which he purified from the material found in rooster combs and umbilical cords. I became familiar with his work because we occupied adjoining labs at old Retina Foundation.

    The second major player was Robert (“Robbie”) Stegmann, MD, a young South African ophthalmologist who spent a fellowship year with me in Boston in the early 1970s. I accepted Robbie on the basis of a sincere handwritten letter, but when I told the hospital director about Robbie, he warned me that I had better ask for his formal credentials since he had heard of a number of South African imposters who had falsified their papers.

    I guess my letter asking for credentials crisscrossed the Atlantic as Robbie traveled from Pretoria to Boston; he never received my request. When he arrived on Jan. 1, we both agreed that, while starting the fellowship, he would also try to gather the required credentials.

    Happily, Robbie turned out to be one of the most remarkable people I have ever met. He was intelligent, curious and had great surgical skills. He was also a gifted tennis player and golfer and a remarkable teller of stories, all with the perfect dialect and an expert’s knowledge of wines and also … diamonds. My kids actually called him 007.

    Dr. Stegmann’s connection to Healon came about after he finished his training in Boston and South Africa, when he was chosen as chief of ophthalmology at a new 2000-bed government hospital in South Africa. While there, he was able to recruit patients for a clinical trial studying the value of Healon in IOL implantation, compared to a control group operated on with the traditional method. At this government hospital, Robbie could hospitalize the 20 patients for a full month for the price of $2. Thus, he could follow the post-op status for each operated patient on a daily basis.

    The third player was Pharmacia, a small Swedish company whose major product was IV Dexran solutions. In the 1970s, they had licensed Balazs’ hyaluronic acid patent and planned to market it as an injectable treatment for equine arthritis.

    Here, luck stepped in as a double agent. When the equine arthritis market turned out to be too small, the company decided to close their manufacturing facility. But their luck and mine were about to change.

    After experiencing a high incidence of post-op edema after IOL implantation I became the next player in the viscoeleastic story. I realized that we needed a viscous, physiologically acceptable lubricant prior to implantation to protect the endothelial layer. I wondered if Dr. Balazs’ Healon was “that” lubricant. After I asked him if he could supply me with enough Healon for some animal experiments, Pharmacia agreed to help.

    When Balazs enthusiastically reported positive results in my animal studies to Pharmacia, we arranged a meeting in New York. During that meeting, I performed an IOL implantation on an enucleated rabbit eye, using Healon before to IOL implantation. As I injected the viscous Healon into the anterior chamber, the head of research (and, incidentally, the brother of the actor Max Von Sydow) blurted out, “So that’s how it works.”

    After that meeting, the pace of the story picked up. I used Healon for IOL implantation in a small series of patients at my hospital, with excellent results. I shall never forget the time a fellow ophthalmologist watched me operate and asked what viscous substance I was using. Understanding that we wanted no publicity at this early stage in the study, the OR nurse said, in the most casual manner, “Oh that’s heavy saline.”

    Apparently, the doctor was satisfied and no more questions were asked.

    Luckily, Pharmacia agreed to my suggestion that Dr. Stegmann do a controlled study at his hospital. The lack of edema and the normal endothelial counts in the Healon-treated eyes supported my early findings.

    Surprisingly, all the major eye journals rejected publication of our study. But here again, luck stepped in. When a small circulation journal, The Annals of Ophthalmology, published the work, the game was afoot. In time, Pharmacia sent Dr. Stegmann and myself to meetings around the world to describe the technique of using Healon in IOL implantation.

    What has happened since those glory days? On a technical level, the product has been improved and over a half billion units of visco elastics have been used in eye surgery worldwide.

    On a personal level, Dr. Stegmannn still lives in Pretoria and works in the OR five to six days a week. He has invented a viscocanalostomy procedure for intractable glaucoma and repaired 4,000 to 5,000 eyes with penetrating trauma, using a viscoelastic. We have remained friends for the last 40-plus years and agree that we were two very lucky ophthalmologists to have been part of the Healon story.

    Editor's note: For more on this story, see the "Viscoelastics" chapter by Drs. Miller, Stegmann and Avi Wallerstein, MD, in The History of Modern Cataract Surgery.