Serina Stretton

Silicone Hydrogel Contact Lenses and the Ocular Surface

For 30 years, contact lens research focused on the need for highly oxygen-permeable (Dk) soft lens materials. High Dk silicone hydrogel contact lenses, made available in 1999, met this need. The purpose of this review is to examine how silicone hydrogel lens wear affects the ocular surfaces and to highlight areas in which further research is needed to improve biocompatibility. Silicone hydrogel lenses have eliminated lens-induced hypoxia for the majority of wearers and have a less pronounced effect on corneal homeostasis compared to other lens types; however, mechanical interaction with ocular tissue and the effects on tear film structure and physiology are similar to that found with soft lens wear in general. Although the ocular health benefits of silicone hydrogel lenses have increased the length of time lenses can be worn overnight, the risk of infection is similar to that found with other soft lens types, and overnight wear remains a higher risk factor for infection than daily wear, regardless of lens material. Future contact lens research will focus on gaining a better understanding of the way in which contact lenses interact with the corneal surface, upper eyelid, and the tear film, and the lens-related factors contributing to infection and inflammatory responses.

Solution toxicity in soft contact lens daily wear is associated with corneal inflammation

Purpose. Contact lens-associated solution toxicity manifests as generalized, mild punctate epithelial fluorescein staining and usually is widely reported as asymptomatic, with no substantial clinical sequelae. This study examined the relationship between solution toxicity and corneal infiltrative events (CIEs) in soft contact lens daily wear. Methods. Several nonrandomized interventional clinical trials conducted between May and November 2005 were analyzed retrospectively. Subjects wore commercially available soft contact lenses bilaterally, on a daily schedule, disinfected overnight using marketed lens care solutions for 3 months with monthly disposal. Solution toxicity was defined as diffuse punctate staining in at least four of five areas of the cornea after instillation of sodium fluorescein. First events of corneal staining or corneal infiltrates were used to calculate incidence (per 100 eye months). Results. Toxic staining was detected in 77 of 609 subjects and all CIEs were mild and symptomatic or asymptomatic. The incidence of CIEs in eyes with a predisposition to toxic staining was 6.7% and in unaffected eyes was 2.3%. CIEs were 3-times more likely to occur in eyes that exhibited solution toxicity compared to unaffected eyes (odds ratio = 3.08, p = 0.008, 95% CI 1.40 to 6.76). Previous events of limbal redness (≥grade 2.0) were not associated with CIEs (odds ratio = 1.53, p = 0.364, 95% CI 0.63 to 3.70). The rate of CIEs increased as the rate of toxic staining increased for specific lens type-solution combinations (Spearman’s rho = 0.558, p = 0.025, n = 16), and peroxide-based solutions consistently resulted in the lowest rates of toxic staining and corneal inflammation. Conclusions. Eyes that experience solution toxicity are more likely to experience a CIE. Daily wear soft lens wearers should be routinely examined with sodium fluorescein soon after lenses are inserted and alternative solution/lens type combinations should be investigated if toxic staining is detected.

Superior epithelial arcuate lesions with soft contact lens wear.

Background Superior epithelial arcuate lesions (SEALs) are an infrequent and often asymptomatic complication of conventional soft contact lens wear. The characteristic arcuate pattern of the full-thickness corneal epithelial lesion usually occurs in the area covered by the upper eyelid, within 2 to 3 mm of the superior limbus in the 10- and 2-o’clock region. Methods Literature on SEALs and recent clinical records from clinical trials using two types of prototype high Dk soft contact lenses were reviewed to gain greater insights into the etiology of SEALs. Results and Conclusions The reported low incidence of SEALs is partly because SEALs are not usually symptomatic. The etiology of SEALs is multifactorial. Our current hypothesis is that SEALs are produced by mechanical chaffing at the peripheral cornea. This chaffing occurs as a result of inward pressure of the upper lid, in an area where the peripheral corneal topography and lens design, rigidity, and surface characteristics combine to create excessive “frictional” pressure and abrasive shear force on the epithelial surface. Patient characteristics such as gender, age, and specific corneal and lid topographies also appear to influence the occurrence of SEALs. Prototype silicone hydrogel lenses are made from higher modulus materials with surfaces that seem to differ subtly in wettability in some patients. The prevalence of SEALs may well increase with the first generations of these lenses.

Comparison of the performance of 6- or 30-night extended wear schedules with silicone hydrogel lenses over 3 years.

Aim: To compare the clinical performance of silicone hydrogel lenses worn for 6- or 30-nights, with monthly replacement, for 3 years. Methods: In this 3-year prospective clinical trial, 161 subjects were enrolled and 154 commenced extended wear. Clinical performance was assessed by comparing discontinuations and lens surface characteristics (front surface deposits, lens wettability, number of mucin balls), lens fitting performance (primary gaze movement, lens tightness), and physiologic parameters (limbal and bulbar redness, corneal and conjunctival staining, microcysts) and subjective parameters (ratings of comfort and vision) between groups. Results: Eighty-eight subjects remained in the study after 36 months. There were no differences in the probability of subjects surviving in either group, and the major cause of lens-related discontinuation in both groups was contact lens-induced papillary conjunctivitis. There were no clinically important differences in performance between wear schedules. Conclusion: The long-term clinical performance of silicone hydrogels worn for 6- or 30-nights continuously was similar. Clinical markers of hypoxia were low in both groups, and the 6-night wear schedule was not superior to the 30-night wear schedule with regard to preventing lens spoilage, improving corneal physiology, or subjective symptoms of comfort and vision.

Microbial keratitis and vision loss with contact lenses.

Purpose. Microbial keratitis is the only sight-threatening adverse event that occurs with contact lens wear. This article gives a preliminary estimation of the incidence of microbial keratitis and vision loss with continuous-wear contact lenses made from highly oxygen permeable (Dk) materials. Methods. The most up-to-date data available on microbial keratitis and vision loss are collected from a range of sources including industry, private practice, and publications and is reviewed. Results. There have been 16 cases of microbial keratitis with high-Dk silicone hydrogel lenses. Of the 13 where data are available, none have lost two or more lines of best-corrected visual acuity (BCVA). Conclusion. First approximation indicates that the incidence of microbial keratitis with high-Dk silicone hydrogel lenses may be lower than the incidence with low-Dk soft lenses during extended wear. The rate of loss of more than two lines of BCVA is low in patients that develop microbial keratitis with low- and high-Dk soft lenses.

Microbial keratitis in prospective studies of extended wear with disposable hydrogel Contact lenses

Purpose: To report the annualized incidence of microbial keratitis with extended wear of low oxygen transmissible (Dk/t) disposable soft contact lenses from prospective postmarket clinical trials. Methods: Seven hundred ninety subjects were enrolled at the L.V. Prasad Eye Institute (LVPEI), Hyderabad, India from March 1993 to March 2000, resulting in 1231 patient eye years, and 167 subjects were enrolled at the Cornea and the Contact Lens Research Unit (CCLRU), Sydney, Australia from July 1987 to December 1999, resulting in 842 patient eye years. Results: The annualized incidence of microbial keratitis per 10,000 eyes per year of lens wear was 32.5 (95% CI 8.9 to 83.2) for LVPEI, 23.8 (95% CI = 2.9 to 85.8) for CCLRU; when data are combined across both centers, the incidence was 28.9 (95% CI = 10.6 to 63) per 10,000 eyes per year of lens wear. This equates to 57.0 per 10,000 wearers or 1 in 173 wearers per year of lens wear. All events were rated as slight to moderate in severity and did not result in visual loss. Two events were described to highlight the challenges in diagnosis and treatment of microbial keratitis. Conclusions: The incidence of microbial keratitis with extended wear of low-Dk/t disposable lenses was higher in these prospective studies (1 in 210 wearers per year at CCLRU and 1 in 154 wearers per year at LVPEI) than that seen in retrospective population-based surveillance studies (1 in 500 wearers per year). Practitioners and patients should always be alert to signs and symptoms, and practitioners should adopt conservative strategies for diagnosis and management of contact lens-related adverse events.

Changes in myopia with low-Dk hydrogel and high-Dk silicone hydrogel extended wear

Purpose. This study compared changes in myopia between wearers of high-oxygen permeability (Dk) silicone hydrogel lenses and low-Dk hydrogel lenses after 1 year of extended wear (EW). Methods. Ninety-two adult subjects were randomly assigned to a lens type. Subjective refraction and autokeratometry were performed at baseline and at 6 and 12 months. Results. After 6 months of EW, myopia (spherical equivalent) regressed by 0.18 ± 0.33 D (p < 0.001) in the high-Dk silicone hydrogel group and progressed by −0.23 ± 0.36 D (p < 0.001) in the low-Dk hydrogel group. There were no further changes after 12 months. Previous lens wear history, baseline refractive error, and age and gender did not have an impact on the change in myopia, and only 35% of the variation could be accounted for by changes in corneal curvature and lens type. Conclusion. Soft contact lens type significantly affects the direction of change in myopia during EW. We hypothesize that these changes are driven by pressure-related redistribution of corneal tissue in high-Dk silicone hydrogel lens wearers and by hypoxia-associated corneal thinning in low-Dk hydrogel wearers. More long-term studies are required to confirm whether the effects of high-Dk silicone hydrogel lens wear on myopia are permanent.

Corneal ulceration in pediatric patients: a brief overview of progress in topical treatment.

Pediatric microbial keratitis is a rare but potentially devastating condition. The condition is similar to adult microbial keratitis, but is often characterized by a more severe inflammatory response. The micro-organisms that cause microbial keratitis in children are similar to the causative agents in adults, with herpes simplex and bacteria being the predominant causative agents, and fungi being less frequent. Of the bacterial pathogens, Pseudomonas aeruginosa, Staphylococcus aureus and α-hemolytic streptococci are common.The risk factors for pediatric keratitis include colonization of the eyes during birth and trauma to the cornea. Certain microbial factors involved in microbial keratitis are common to all micro-organisms, including adhesion to the cornea, penetration into the cornea, destruction of the corneal stroma (usually by microbial and/or host proteases), and recruitment of white blood cells to help defend the eye. Specific inflammatory responses that occur during pediatric microbial keratitis are not known in detail, but it is likely that cytokines and polymorphonuclear leucocytes are major factors, as they are in adult microbial keratitis.Treatment for pediatric microbial keratitis is usually the same as treatment for adult microbial keratitis; topical application of antimicrobial agents initially, followed by application of anti-inflammatory agents. With pediatric microbial keratitis, extra care must be taken to ensure nontoxicity due to blood adsorption. New microbial keratitis treatments are being developed and these mainly focus on new antimicrobials, antivirulence agents (such as vaccination against microbial toxins) or specific anti-inflammatory agents.There remains a clear need for increased research into the specific responses during microbial keratitis in children which will help progress new therapies as well as the development of new antimicrobials, especially new antifungal therapies.

Artificial Cornea: Towards a Synthetic Onlay for Correction of Refractive Error

Synthetic onlays that are implanted onto the surface of the cornea have the potential to become an alternative to spectacles and contact lenses for the correction of refractive error. A successful corneal onlay is dependent on development of a biocompatible polymer material that will maintain a healthy cornea after implantation and that will promote growth of corneal epithelial cells over the onlay, and development of a method for attachment of the onlay with minimal surgical invasiveness. The ideal onlay should be made of a material that is highly permeable yet has sufficient surface characteristics to stimulate stable and firm attachment of the corneal epithelium over the onlay. Recent research indicates that collagen I coated polymer materials that mimic the basement membrane of the corneal epithelium promote the most favorable growth of epithelial cells in vivo in comparison to wholly biological or synthetic materials.

Corneal hypoxia secondary to contact lenses: the effect of high-Dk lenses

Contact lenses made from materials of low-oxygen permeability (Dk) do not meet the oxygen requirements of the cornea for overnight wear. Long-term extended wear of these lenses results in chronic changes to all layers of the cornea, many of which are associated with hypoxia. High-Dk silicone hydrogel and gas permeable lenses are now available for 30-night continuous wear. The high-oxygen transmissibilities of these lenses have enabled the development of a successful continuous wear modality by eliminating the hypoxic effects of long-term wear. Presently, the focus is on improving lens performance by developing lenses that are more biocompatible, provide greater comfort, and maintain a stable tear film without inflammatory or mechanically induced adverse events.