Glistenings are fluid-filled imperfections that develop in certain intraocular lens materials, post-operatively. These vacuoles of fluid unevenly scatter light as it passes through the lens to the patient’s retina, impairing visual function by causing disability glare. Important points of interest:
- Approximately 200,000 cataract surgeries are performed in Ontario annually; 60% of these patients receive the Alcon Acrysof lens which is prone to water vacuole (termed "glistenings" due to their clinical appearance)
- At 3 years postoperatively, 97% of Acrysof patients will have glistenings and up to 60-87% of these patients will have moderate to severe glistenings; the severity of the glistenings continues to increase with time and does not level off.
- A pilot study (conducted on 90 patients) that I have conducted has suggested that 10% of these patients with Alcon lenses (which are prone to glistenings) were involved in some motor vehicle accident by 2 years after surgery; a comparable group of patients with a glistening free lens did not have any accidents.
- Previously, cataract patients were primarily elderly (average age 76 about a decade ago); however, now the average age is lower and nearer 65; a gradual worsening of visual function could affect their ability to drive safely and maintain their independence; of note is that historically, drivers in the 55-65 year age group were considered to be the safest drivers
- The impact on vision is much more significant in low-lighting conditions – conditions which again constitute a higher risk for car accidents;
- This phenomenon has affected some individuals to the point where they have required a surgical procedure to have the offending intraocular lens removed because it has become intolerable; this surgery to replace the lens is associated with a 30% risk of serious eye complications
- The material which is most recognized for this phenomenon is still widely-used, and patients are still being exposed to this long-term, post-operative problem. With our aging demographics, the incidence of this issue, and the liability associated with its effects, the potential impact on patient safety, and health care costs is quite large.
- Health Canada is aware of this situation and has issued an advisory.
- Health Shared Services BC issued a province wide RFP for intraocular lenses in 2013; based on clinical criteria, Alcon Acrysof lenses were not chosen; in Quebec, certain hospitals that have contracts with Alcon have decided to exclude patients less than 60 yrs of age from having this lens implanted at the time of cataract surgery.
- Current purchasing practices of Ontario hospitals involve bundling of products/services which makes it hard for surgeons to use other lenses if Alcon is awarded the contract, even if patients agree to pay as there are quotas that hospitals impose on them.
The Ontario Government is funding an out-dated and flawed cataract technology, which is being implanted into patients as a result of a procurement system that promotes short term financial gain but results in patients receiving lower quality products. These practices are jeopardizing the health and safety of cataract patients, primarily seniors, and are putting the general public at risk.
George Beiko BM BCh FRCSC