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Biomedical subjects

Deborah F Sweeney

Publications and source records attributed to Deborah F Sweeney.

At least 19 recordsLinked to original sources
PubMed2006

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.

Contact Lenses, Extended-Wear↗
PubMed2006

Two presentations of contact lens-induced papillary conjunctivitis (CLPC) in hydrogel lens wear: local and general.

PURPOSE: The purpose of this study was to confirm that two distinct clinical presentations of contact lens-induced papillary conjunctivitis (CLPC), local and general, occur in hydrogel lens wear. METHODS: Retrospective analyses of 124 CLPC events were identified. The classification of CLPC was based on location and extent of papillae. CLPC was classified as local if papillae were present in one to two areas of the tarsal conjunctiva and general if papillae occurred in three or more areas. The CLPC events were compared with an asymptomatic control group in prospective clinical trials conducted from 1993 until 2003 at two clinical sites, Australia and India. Two hundred sixteen subjects from Australia and 914 subjects from India wore either high Dk silicone hydrogel or low Dk hydrogel lenses on a 6-night (6N) or 30-night extended-wear (EW) schedule. The physiological responses of the ocular surface, including tarsal conjunctiva redness and roughness, number of papillae present, lens fit and performance, and subjective patient symptoms, were measured during each visit at each site. These variables listed were compared between local CLPC groups and asymptomatic controls and general CLPC groups and asymptomatic controls. RESULTS: Two types of CLPC in hydrogel lens wearers have been confirmed. Of the 124 CLPC events, there were 61 local and 63 general events. Local and general CLPC cases reported significantly greater frequency of symptoms compared with the asymptomatic controls, in particular itching, lens awareness, secretion, and blurred vision (p < 0.1). CONCLUSIONS: The classification of CLPC into two types, local and general, in hydrogel lens wear was confirmed based on presentations at both sites. This distribution of papillae between local and general CLPC may indicate separate etiologies involved in the pathogenesis of the condition.

Adolescent↗
PubMed2006

The Max Schapero Memorial Award Lecture 2004: contact lenses on and in the cornea, what the eye needs.

PURPOSE: The aim of this study is to review the advances made in understanding the needs of the cornea and the way in which it responds to contact lens wear and corneal implants. METHODS: The review is based on personal knowledge and involvement of the author and colleagues from the 1970s to 2005. RESULTS: Development of silicone hydrogel contact lenses is presented as well as development of synthetic materials for implantation on the corneal surface (corneal onlay). CONCLUSIONS: The future of vision correction involves developing highly porous and biocompatible lens materials. For contact lenses, a better understanding of the effects of contact lens wear on the ocular surfaces, including the tear film, and development of lens materials with greater bacterial resistance are required. For those who require new solutions to permanent vision correction, corneal onlays (implantable contact lenses) are a minimally invasive and totally reversible procedure that can be removed or replaced as visual needs change over time.

Contact Lenses↗
PubMed2006

Two-year preclinical testing of perfluoropolyether polymer as a corneal inlay.

PURPOSE: To assess the long-term biocompatibility and optical clarity of a perfluoropolyether (PFPE) polymer as a corneal inlay. METHODS: A 4-mm-diameter PFPE inlay was implanted under a microkeratome flap in the corneas of rabbits (n = 16) and maintained for predetermined time points of 6, 12, or 24 months. These were compared with normal (n = 3) and time-matched sham-wounded rabbit corneas (n = 8). All corneas were monitored clinically with a slit lamp. Histology was performed on all eyes on termination to assess the tissue response. RESULTS: Some sham and implanted animals were discontinued from study 1 to 2 days after surgery because of flap dislodgement. Ten animals with PFPE inlays remained in the study, and 7 of these were maintained to their predetermined time point for up to 2 years (3 were discontinued because of peripheral corneal defects). The corneas of these 7 animals remained clear and healthy, tear film remained normal, and there were no signs of inflammation, neovascularization, or increased conjunctival redness. All inlays remained centered and optically clear (clarity 85% or greater). Histology showed PFPE was biostable. The epithelia of operated corneas were stratified but slightly thinned compared with those of normal corneas. Stromal tissue anterior and posterior to each inlay appeared normal. Keratocytes in the vicinity of the inlay were normal in distribution but showed increased vacuolation, indicating tissue repair after the surgery. CONCLUSIONS: The PFPE polymer maintained a high level of optical clarity and showed long-term biocompatibility for up to 2 years when implanted as an inlay in the rabbit cornea.

Actins↗
PubMed2006

Accommodative facility in eyes with and without myopia.

PURPOSE: To compare accommodative facility in eyes with myopia to that in eyes with emmetropia or hyperopia and to determine whether accommodative facility can be used to predict an association with myopia. METHODS: In the Sydney Myopia Study, year-1 school children (6.7 +/- 0.4 years) were assessed for accommodative facility at distance (3 m) and near (33 cm) with semiautomated flippers. Spherical equivalent refractive error (RE) was defined as myopia (< or = -0.50 D), emmetropia (> -0.50 D, but < +1.50 D), and hyperopia (> or = +1.50 D) based on postcycloplegia readings. Only right eye data were considered. Differences between groups were analyzed with the Brown-Forsythe F test after adjustment for age and gender. Multiple comparisons were adjusted with the by the Games-Howell METHOD RESULTS: Of the 1328 right eyes assessed, 20 (1.5%) eyes were myopic, 977 (73.6%) were emmetropic, and 331 (24.9%) were hyperopic. At distance, mean facility was less for myopic eyes at 5.5 +/- 2.0 cycles per minute (cpm) in comparison to 6.9 +/- 1.7 cpm for eyes with emmetropia or hyperopia (P = 0.005). Myopic eyes recorded greater positive and negative accommodative response times than did emmetropic or hyperopic eyes (P < 0.05). There were no differences among the groups in near facility. The area under the receiver operating characteristic (ROC) curve for distance facility was 0.692 (P = 0.003, 95% CI, 0.580-0.805). CONCLUSIONS: Myopic eyes have reduced accommodative facility at distance, and accommodative responsiveness to both positive and negative defocus is slow. However, accommodative facility as a test does not have sufficient power to discriminate eyes with myopia from other refractive errors.

Accommodation, Ocular↗
PubMed2005

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.

Adolescent↗
PubMed2004

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.

Adult↗
PubMed2003

Comparison of adverse events with daily disposable hydrogels and spectacle wear: results from a 12-month prospective clinical trial.

OBJECTIVE: To evaluate the type and incidence of adverse events seen with daily disposable hydrogel contact lens wear compared with a control (spectacle) group over 12 months. DESIGN: Prospective, randomized, observer-masked, comparative clinical trial. PARTICIPANTS: Two hundred eighty-one myopes with no prior contact lens wear experience were enrolled from August to December 1996. Subjects were 16 to 35 years old and had refractive errors ranging from a -0.75-diopter (D) sphere to a -6.00-D sphere with a cylinder less than -1.00 D. INTERVENTION: Each subject was randomly assigned to wear either bilateral disposable hydrogels on a daily disposable wear schedule or spectacles. MAIN OUTCOME MEASURE: Type and incidence of adverse events from each group. Adverse events were categorized as serious, significant, and nonsignificant based on the potential to cause vision impairment, severity at event, and level of clinical concern. RESULTS: At baseline, 1.6% of eyes had asymptomatic infiltrates that were nonsignificant. During the study, asymptomatic infiltrates were seen in both contact lens and spectacle groups at 20.5 events versus 11.3 events per 100 eyes per year of wear. No significant events were seen with the spectacle group. With the contact lens group, the type and incidence of significant events per 100 eyes per year of lens wear were corneal peripheral ulcer, 2.5 events; infiltrative keratitis, 1.5 events; and papillary conjunctivitis, 1 event. The incidence of both significant and nonsignificant events was greater with the contact lens group (P<0.05). No serious events (i.e., microbial keratitis) were seen in either group. A greater number of subjects were lost to follow-up or permanently discontinued from the contact lens group relative to the spectacle group (33% vs. 17%, P = 0.002). Lens-related problems such as dryness, discomfort, and difficulty with insertion and removal accounted for 27% of discontinuations from the contact lens group. Poor compliance (40%) was the greatest reason for discontinuations from the spectacle group. CONCLUSIONS: No clinically serious events were seen with either group. Only a small percentage of contact lens-wearing eyes presented with significant events, which is promising for daily disposable lens wear. Far more contact lens subjects were lost to follow-up or discontinued. Small, asymptomatic, subepithelial corneal infiltrates of unknown significance were seen in both contact lens- and spectacle-wearing eyes.

Adolescent↗
PubMed2003

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.

Contact Lenses↗
PubMed2003

Corneal epithelial thinning profile induced by long-term wear of hydrogel lenses.

PURPOSE: To characterize the epithelial thickness profile and study the effects of long-term wear of hydrogel lenses on this profile. METHODS: A cross-sectional study was designed. Epithelial thickness was evaluated in 15 subjects who had worn one of two types of low oxygen transmissibility (Dk) hydrogel contact lenses for an average of 10 years (range, 7-16) and compared with a group of 18 control subjects who had never worn contact lenses. Epithelial thickness was measured at the center and at four mid-peripheral and four peripheral locations in the vertical and horizontal meridians of the cornea using a modified optical pachymeter. RESULTS: Lens wearers had significantly thinner epithelium than controls [analysis of variance (ANOVA), p < 0.001] in the central (41 +/- 7 microm versus 48 +/- 5 microm), mid-peripheral (41 +/- 7 microm versus 48 +/- 7 microm), and peripheral (42 +/- 9 microm versus 48 +/- 6 microm) cornea. The extent of this difference ranged from 8.7% to 18.4% of the total epithelial thickness, was not associated with the duration of wear (ANOVA, p = 0.87, power = 0.05), and was significantly greater for the lower Dk contact lens type (ANOVA, p < 0.001). Topographical position did not have a significant effect on epithelial thickness (ANOVA, p > 0.13, power > 0.22). CONCLUSION: This study establishes that the epithelial thinning associated with hydrogel lens wear is topographically uniform. It also confirms that this effect is inversely related to lens oxygen transmissibility but does not appear to increase with longer duration of wear.

Adult↗
PubMed2003

Clinical characterization of corneal infiltrative events observed with soft contact lens wear.

PURPOSE: Corneal infiltrates are commonly observed during adverse reactions associated with contact lens wear. Broad ranges of presentations are encountered, and there is no well-established classification system. The aim of this paper is to categorize corneal infiltrates associated with soft lens wear and present the typical clinical characteristics associated with each type of event. METHODS: All events of corneal infiltrates occurring in soft contact lens clinical trials over 10 years (9 years retrospective and 1 year prospective) and conducted at two contact lens research centers were reviewed by a panel of experts comprising ophthalmologists, optometrists, and other biologic scientists. Classification of each event was based on assessment of a range of signs and symptoms by the review panel. RESULTS: A classification scheme was devised to distinguish infiltrative events that were serious and symptomatic (microbial keratitis), clinically significant and symptomatic (contact lens-induced peripheral ulcer, contact lens-induced acute red eye, infiltrative keratitis), and clinically nonsignificant and asymptomatic (asymptomatic infiltrative keratitis and asymptomatic infiltrates). CONCLUSION: Corneal infiltrates can be classified into six distinct categories. This classification scheme, based on clinical characteristics, should aid diagnosis, management, and treatment of corneal infiltrates as well as assisting investigations into the etiology of each of these conditions.

Contact Lenses, Hydrophilic↗
PubMed2003

Altered conjunctival response after contact lens-related corneal inflammation.

PURPOSE: Corneal inflammation in overnight contact lens (CL) wear is not fully understood. We designed a masked study to examine the impact of overnight CL wear on clinical variables in subjects who had previously experienced corneal inflammatory disease. METHODS: Forty-four subjects were entered into the study: Nine subjects who had previously experienced CL-associated acute red eye (CLARE) and nine controls; 13 subjects who had previously experienced CL-induced peripheral ulceration (CLPU) and 13 controls, respectively. Controls were matched for age, gender, CL wear experience, and refractive error. Subjects wore bilateral disposable CLs (-3.00 DS). Corneal, conjunctival, and CL fitting variables were assessed prior to sleep, after a single night of CL wear, at 1, 2, and 4 hours after waking by clinicians who were masked to group membership. Retrospective analysis of prewear corneal and conjunctival variables for CLARE subjects and their respective controls was also performed. RESULTS: Contact lens-associated acute red eye subjects consistently showed higher limbal redness (p < 0.05), bulbar redness (p < 0.05), and conjunctival staining (p < 0.005) compared with controls. Lens fitting and corneal variables were not significantly different at any time point for CLARE subjects. Contact lens-induced peripheral ulceration subjects were not different from matched controls for any variable at any time point. Limbal redness varied significantly over time among controls, with highest values measured at eye opening (p < 0.05). Retrospective analysis of prewear variables showed no significant differences between CLARE and control subjects. CONCLUSIONS: Wearers who previously experienced CLARE had a greater conjunctival response to CL wear compared with wearers who had no previous inflammatory disease. Clinical observations, however, were not helpful in predicting wearers who were predisposed to CLARE.

Adult↗
PubMed2003

Mucin balls with wear of conventional and silicone hydrogel contact lenses.

PURPOSE: To compare the frequency of mucin balls in subjects wearing conventional and high-Dk silicone hydrogel lenses during 12 months of extended-wear and to determine whether mucin balls are associated with any lens or subject characteristics. METHODS: This study used data from a clinical trial where subjects wore either conventional hydrogel (N = 69, 6-night extended-wear) or silicone hydrogel (N = 70, 30-night extended-wear) contact lenses for 12 months. The number of mucin balls and other physiological responses, lens fit and performance, and subjective patient responses to lens wear were rated at each scheduled visit. RESULTS: Subjects in the silicone hydrogel group had significantly greater numbers of mucin balls compared with subjects in the conventional hydrogel group over time (p < 0.001), but there were no significant differences in the percentage of subjects with mucin balls between the two groups. Increasing lens wettability, back surface deposits, and time of lens wear were associated with higher numbers of mucin balls in the conventional hydrogel group (p < 0.05); steeper corneal curvature and increasing lens wettability, back surface deposits, and number of microcysts were associated with higher numbers of mucin balls in the silicone hydrogel group (p < 0.05). CONCLUSIONS: This study indicates that a subset of the population is predisposed to develop mucin balls irrespective of the soft contact lens type worn, but lens type influences the degree of mucin ball formation. The relationship between lens wettability, back surface deposits, and steeper corneal curvature with mucin balls supports the hypothesis that the mechanical interaction of a lens with the surface layer of the epithelium and the tear film in association with the blinking forces of the lid is involved in mucin ball formation.

Adult↗
PubMed2003

Clinical signs of hypoxia with high-Dk soft lens extended wear: is the cornea convinced?

PURPOSE: To assess the effectiveness of high-Dk soft contact lenses with oxygen transmissibility (Dk/L) beyond the critical level required to avoid corneal edema during overnight wear. METHODS: The most up-to-date data available on clinical signs of hypoxia with high-Dk contact lenses is reviewed. RESULTS: Chronic corneal edema associated with hypoxia is responsible for the development of large numbers of microcysts, limbal hyperemia, neovascularization, and small increases in myopia. Silicone hydrogel lenses worn continuously for up to 30 nights prevent corneal edema during overnight wear and do not induce a microcyst response. Long-term clinical trials indicate the mean level of limbal redness for patients wearing high-Dk lenses during continuous wear are equivalent to nonlens wearers. No changes in refractive error are associated with continuous wear of high-Dk lenses. CONCLUSION: High-Dk silicone hydrogel lenses can be worn for up to 3 years with virtual elimination of the hypoxic consequences observed with low-Dk lenses made from conventional lens materials.

Contact Lenses, Extended-Wear↗
PubMed2003

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.

Adult↗
PubMed2003

A comparison of biological coatings for the promotion of corneal epithelialization of synthetic surface in vivo.

PURPOSE: To investigate the effect of a range of biological coatings on corneal epithelialization of a synthetic polymer surface in vivo. METHODS: Eight diverse biological factors (collagen I, collagen III, collagen IV, laminin, fibronectin, endothelial extracellular matrix, hyaluronic acid, and chondroitin sulfate) were coated individually onto the surface of polycarbonate membranes with a pore size of 0.1 micro m. The coated membranes were implanted on the anterior cornea of adult cats and were clinically assessed for rapidity and extent of and persistence of epithelial overgrowth. The membranes with persistent epithelial attachment were examined histologically by immunohistochemistry and routine light and electron microscopy. RESULTS: Collagen I, collagen IV, and laminin consistently enhanced migration and attachment of corneal epithelial cells in vivo. Multiple-layered epithelium over the collagen I-, collagen IV-, and laminin-coated membranes was demonstrated histologically. The collagen I-coated membranes performed best, in that they showed greater stratification and differentiation of the epithelium. Formation of basement membrane and adhesion complexes over the collagen I-coated membranes was detected by immunohistochemistry and electron microscopy up to 9 weeks after implantation. Membranes coated by fibronectin, endothelial extracellular matrix, hyaluronic acid, and chondroitin sulfate did not support persistent epithelial overgrowth. Compromised biostability of these coatings was mostly likely associated with postsurgical reactions of the host corneal tissue. CONCLUSIONS: A biologically modified polymer can support migration and adhesion of corneal epithelial cells in vivo. The collagen I-modified surface exhibited the most promising performance, both clinically and histologically.

Animals↗
PubMed2002

Case reports of three atypical infiltrative keratitis events with high DK soft contact lens wear.

PURPOSE: We report three atypical infiltrative keratitis events in patients that had successfully worn highly oxygen permeable (Dk) soft contact lenses on an extended wear (EW) schedule for at least 15 months. These cases highlight the role of patient/practitioner education, patient compliance, examination, and appropriate referrals that are required to reduce the risk of complications during lens wear. METHODS AND RESULTS: Each patient had been wearing high Dk soft lenses on an EW schedule with monthly replacement for at least 15 months and presented with severe pain, redness, and photophobia. The events were characterized by focal infiltrate(s) with an overlying epithelial defect in the superior periphery to mid-periphery of the cornea and extensive diffuse infiltration. CONCLUSIONS: The signs and symptoms of each case were more severe than is typically associated with contact lens-related infiltrative keratitis. Because of the slow progression of signs and relatively fast resolution, the cases were not found to be microbial keratitis. Although high Dk soft contact lenses overcome hypoxia-associated complications associated with extended wear, patients and practitioners must be vigilant as adverse events can still occur and in rare instances can be severe. Education and patient compliance are a crucial part of successful management of patients on EW schedules. Constant reinforcement is necessary to ensure patient compliance.

Adult↗