The nanoFLEX® Collamer® IOL
The science behind the unique, highly advanced biocompatible lens material.
The nanoFLEX® IOL is a single-piece lens designed to treat aphakia. This lens combines STAAR’s proprietary Collamer® material — the same material used in the Visian® ICL — with an advanced C2 Aspheric Optic designed to deliver optimal outcomes. It provides optimized visual performance and an integrated anti-reflective interface, making it nearly identical to the eye’s natural crystalline lens.1
Collamer is a STAAR Surgical proprietary copolymer material derived from porcine collagen and a polymethacrylic base used to manufacture a range of advanced implantable ophthalmic phakic and aphakic lenses. The addition of 0.3% covalently bonded porcine collagen, poly-HEMA (a 30% water hydrogel material hydroxyethyl methacrylate) and a covalently bonded ultraviolet-blocking chromophore result in the body’s fibronectin bonding to the lens surface. Thus, the body subsequently recognizes the material as natural body tissue, which in turn prevents the initiation of protection mechanisms, thus preventing otherwise typical calcification. The collagen protein conveys a negative charge to the nanoFLEX IOL, which may assist in repelling negatively charged proteins in the aqueous humor (Figures 1 and 2). Human fibronectin has a specific affinity for the type of collagen incorporated in the nanoFLEX IOL.2 Over the course of several weeks, fibronectin forms a layer which covers the nanoFLEX, further reducing the likelihood that the body’s immune system will recognize the IOL as a foreign substance. From a biocompatibility perspective, the nanoFLEX IOL passes all standard ophthalmic device testing and is clinically “quiet,” eliciting very little inflammatory response in the eye.3
Acrylic lens after 1-minute exposure to protein mixture, magnified 1000 times. Note dense protein deposition.
Collamer lens after 1-minute exposure to the same protein mixture, magnified 1000 times. Note near absence of protein deposition.
The Collamer material found in the nanoFLEX IOL discussed in this supplement has demonstrated optimal optical, mechanical, chemical and clinical/biological properties so unique they can’t be compared to any similar material in the ophthalmic industry.
nanoFLEX IOL Attributes
Collamer is 100% pure copolymer material that is biologically and optically quiet in the eye. nanoFLEX’s hydrophilic properties have an integrated anti-reflective interface that’s a unique, highly advanced biocompatible material. It’s easy to implant because it unfolds gently in the eye. Furthermore, collamer has the ability to repair itself when exposed to YAG laser energy.
Collamer transmits light in a way that is similar to the natural lens. nanoFLEX is designed to provide sharp image quality and increased functional vision. It’s designed to have a negative spherical aberration of -0.019 microns. This compensates for a mild positive spherical aberration of the cornea and improves contrast sensitivity without compromising depth-of-field vision (Table 1).
% Water Content | % Water Content at Lens Surface | Refractive Index | Theoretical Refractive Index at Lens Surface | Difference in Refractive Index Lens Surface vs Aqueous | |
---|---|---|---|---|---|
Hydrophobic Acrylic | 0% | 0% | 1.550 | 1.550 | 0.214 |
Collamer | 40% | 95% | 1.442 | 1.360 | 0.024 |
Aqueous | >99% | N/A | 1.336 | N/A | – |
nanoFLEX Specifications | |
---|---|
Model | CC4204A |
Optic | 6.0mm, Biconvex |
Length | 10.8mm |
Haptic | Collamer, Single-Piece (Plate) |
Diopters | 10.5 to 30.5 |
A-Constant | 118.6 (suggested) |
ACD | 5.32mm |
Fibronectin and Collamer
Collagen in the nanoFLEX IOL attracts fibronectin and develops a monolayer on the surface of the lens. Fibronectin has an affinity to collagen-inhibiting cell adhesion to the lens and deposition of other proteins. And once the monolayer is formed, nanoFLEX is not recognized as a foreign body (Figure 3). ■
Due to the chemical composition of Collamer, fibronectin has a natural affinity for nanoFLEX, which results in providing an immunological shield to the body’s defense mechanism.2
References
1. IOL Roundtable: Close-up on Collamer. A supplement to Ophthalmology Management; May 2000.
2. Till, JS. Collamer intraocular lens implantation with active uvetis. J Cataract Refract Surg 2003;29:2439-2443.
3. Data on file. STAAR Surgical, Monrovia, Calif.
4. Gontijo I, The Collamer Story. 2006. Data on file. STAAR Surgical, Monrovia, California.
5. Ossipov A. Comparison of internal reflectance patterns of COLLAMER®, acrylic, and silicone. 1997. Data on file, STAAR Surgical.
6. Kawai K, Hayakawa K, Suzuki T. Simulation of 20 Year Deterioration of Acrylic IOLs Using Severe Accelerated Deterioration Tests. Tokai J Exp Clin Med. 2012;37(3):62-65.