เทคนิคการผลิตและการทดสอบคอนแทคเลนส์
เทคนิคการผลิตและการทดสอบคอนแทคเลนส์
เทคนิคการผลิตคอนแทคเลนส์
การซึมผ่านของออกซิเจนของวัสดุคอนแทคเลนส์และมาตรฐานการทดสอบ
Oxygen permeability of contact lens materials and testing standards
ทำไมจึงต้องมีการตรวจวัดการขนส่งออกซิเจนของคอนแทคเลนส์?
ความสำคัญของออกซิเจนต่อสุขภาพของกระจกตาเป็นที่รู้จักกันดี ด้วยเหตุนี้ผู้ใช้คอนแทคเลนส์ใส่ใจในผลิตภัณฑ์ที่มีประสิทธิภาพออกซิเจนสูงที่ได้รับการพิสูจน์แล้ว
ผู้ผลิตเลนส์จะระบุข้อมูลจำเพาะของผลิตภัณฑ์ต่างๆ รวมถึงความสามารถในการซึมผ่าน และการแพร่กระจายของออกซิเจนโดยปกติจะส่งให้กับผู้เชี่ยวชาญด้านการดูแลดวงตา ซึ่งสามารถให้คำแนะนำผู้ใช้เกี่ยวกับทางเลือกที่เหมาะสมที่สุดสำหรับความต้องการเฉพาะ ความสามารถในการซึมผ่านเรียกว่า Dk และการส่งผ่าน Dk / t คุณสมบัติเหล่านี้ได้มาจาก
D - the material diffusion coefficient
k - the oxygen solubility
t - the lens thickness
เครื่องวิเคราะห์การซึมผ่านของ Systec ไม่เพียงแต่ใช้สำหรับการพัฒนาวัสดุคอนแทคเลนส์ใหม่ ๆ แต่ยังใช้สำหรับการรับรองผลิตภัณฑ์สำเร็จรูปตามมาตรฐาน ISO อีกด้วย สิ่งนี้จะช่วยให้ลูกค้ามั่นใจได้ว่าข้อมูลผลิตภัณฑ์ที่เชื่อถือได้
Why is there a need for contact lens oxygen transport measurement?
The importance of oxygen to the health of the cornea is well known; as a result contact lens users will prefer a product with proven high oxygen performance. Lens manufacturers advertise their various product specifications, including oxygen permeability and transmission, usually to Eye Care Professionals who can then advise patients on the most suitable choices for their particular needs. The permeability is referred to as Dk and the transmission Dk/t. These properties are derived from:
D - the material diffusion coefficient
k - the oxygen solubility
t - the lens thickness.
A given lens material, typically a hydrogel, will absorb an amount of oxygen governed by its k value, while a higher D will ensure rapid movement through the lens. The thicker the lens the further oxygen has to travel consequently reducing its transmission. A contact lens design using a particular material will require its oxygen transmission measured. Higher permeability materials will perform better, together with thinner lenses, but simply choosing the highest Dk material and making thin lenses is not an easy option, as will be explained later. The lens shape and thickness varies with prescription, a focal length of –3.00 Dioptres has been chosen as the standard for oxygen transmission measurement. The thickness in the central region of the lens is used because this covers the most critical area of the cornea.
Types of lenses used today
Conventional hydrogel soft lenses contain a high proportion of water which provides the main path for oxygen diffusion. So for these products the Dk value is directly proportional to the water content of the particular hydrogel used. However the highest Dk materials are difficult to manufacture into thin lenses, resulting in a range of designs, some medium Dk thinner varieties, and other higher Dk thicker ones. The aim is to produce the highest Dk/t to maximise corneal oxygenation, commensurate with comfort and visual performance. The latest silicone hydrogels do not have their oxygen permeability governed by water content alone, but also by their constituent siloxane groups. Contact lenses containing these products are some of the highest performing available today, with very high oxygen transport and the highest levels of comfort.
Rigid gas permeable (RGP) contact lenses are still an attractive alternative to the soft varieties and probably offer better optical performance generally, combined with excellent corneal care. Although initially less comfortable than soft lenses, the Dk values for the RGP polymer materials are on a par with the best silicone hydrogels whilst offering much longer lifetimes with lower long term cost. Measurement Standards In the early days of contact lens use, indeed up to the early 1980’s the importance of corneal oxygenation was not well understood. However since that time international standards have been put in place to enable reliable oxygen permeation testing of lens materials. Early ISO standards 9913-1:1996 and 9913-2:2000 were put in place for polarographic (Fatt method) and coulometric determination of oxygen permeation through all types of contact lenses. However the high Dk Silicone based lenses proved difficult to measure accurately using these standards, in part due to lens dehydration during coulometric procedures. These standards have now been withdrawn and both replaced by ISO 18369-4:2006, which like the previous standards describes the measurement of Dk/t for finished lenses rather than a material sample. This oxygen transmission value is subsequently converted into the Dk value by measuring the lens thickness, t.
Solutions from Systech Illinois
Systech Illinois produce the 8000 range of oxygen permeation analysers, which are capable of measuring contact lens oxygen throughput. Utilising our proprietary coulometric sensor technology to detect oxygen transmission rates, samples are clamped or attached to a diffusion chamber, illustrated in the principle. Pure oxygen (99.9%) is then introduced into the upper half of the chamber while an oxygen-free carrier gas flows through the lower half.
Molecules of oxygen diffusing through the sample into the lower chamber are conveyed to the sensor by the carrier gas. This allows a direct measurement of the oxygen without using complex extrapolations. Oxygen transmission rate of the test sample is displayed as either cc/m2/day or cc/100in2/day.
In summary, it is possible to utilise Systech’s permeation analysers both for the development of new contact lens materials and also for certifying the finished products to the ISO standards. This will ensure trusted product data to instil confidence in professional and consumer alike.
