Kathrine Osborn Lorenz

Atomic force microscopy and scanning electron microscopy analysis of daily disposable limbal ring contact lenses

Limbal ring (also known as ‘circle’) contact lenses are becoming increasingly popular, especially in Asian markets because of their eye‐enhancing effects. The pigment particles that give the eye‐enhancing effects of these lenses can be found on the front or back surface of the contact lens or ‘enclosed’ within the lens matrix. The purpose of this research was to evaluate the pigment location and surface roughness of seven types of ‘circle’ contact lenses.

Clinical evaluation of fitting toric soft contact lenses to current non-users

To evaluate the ease with which astigmats from three groups of current non‐wearers of toric contact lenses can be fitted with current toric soft lenses, and to determine toric lens‐wearing success.

Friction Measurements on Contact Lenses in a Physiologically Relevant Environment: Effect of Testing Conditions on Friction.

Purpose To characterize the effect of lubricant composition and in vitro ageing on the coefficient of friction (CoF) of a wide range of commercially available soft contact lenses (SCLs). Methods The CoF of SCLs was characterized by means of microtribometry against a mucin-coated glass disk. One reusable (RU) silicone-hydrogel (SiHy) lens, senofilcon A, and two daily disposable (DD) lenses, etafilcon A (hydrogel) and nelfilcon A (hydrogel), were tested under different lubricant solutions, including a tear-like fluid (TLF) containing proteins and lipids. Five RU (balafilcon A [SiHy], comfilcon A [SiHy], etafilcon A [hydrogel], lotrafilcon B [SiHy], senofilcon A [SiHy]) and five DD (delefilcon A [SiHy], etafilcon A [hydrogel; two lens types], narafilcon A [SiHy], nelfilcon A [hydrogel]) lenses were tested before and after exposure to an in vitro ageing process, consisting of continuous immersion and withdrawal from TLF for 18 hours. The CoF in TLF was further compared to previously published data collected in a different lubricant. Results After in vitro ageing, three RU (balafilcon A, etafilcon A, comfilcon A) and three DD (delefilcon A, etafilcon A, nelfilcon A) lenses displayed a significant increase in CoF (P < 0.05). Lenses that contained poly (vinyl pyrrolidone; PVP) showed unaltered CoF after ageing. Conclusions An in vitro methodology to simulate in vivo wearing of contact lenses has been proposed. The results suggest that certain lens materials show increased CoF after ageing, with potential clinical implications. The results indicate that the presence of a persistent wetting agent is of advantage to maintain a low CoF after prolonged wearing.

Theoretical fitting characteristics of typical soft contact lens designs

PUROSE To calculate theoretical fitting success rates (SR) for a range of typical soft contact lens (SCL) designs using a mathematical model. METHOD A spreadsheet mathematical model was used to calculate fitting SR for various SCL designs. Designs were evaluated using ocular topography data from 163 subjects. The model calculated SR based on acceptable edge strain (within range 0-6%) and horizontal diameter overlap (range 0.2-1.2mm). Where lenses had multiple base curves (BCs), eyes unsuccessful with the steeper BC were tested with the flatter BC and aggregate SR calculated. Calculations were based on typical, current, hydrogel and silicone hydrogel SCLs and allowed for appropriate on-eye shrinkage (1.0-2.3%). Theoretical results were compared with those from actual clinical trials. RESULTS Theoretical success rates for one-BC lenses ranged from 60.7% (95% CI 7.2%) to 90.2% (95% CI 3.7%). With two-BC designs, most combinations showed a SR increase with a second BC (84.0%-90.2%). However, one of the two-BC combinations showed only negligible increase with a second BC (72.4%-73.0%). For designs with lower SR, the greatest contributor to failure was inadequate lens diameter. For a given design, differences in shrinkage (i.e. on-eye bulk dehydration) had a significant effect on success rate. In comparison with historical clinical data, there was a positive correlation between small lens fitting prevalence and discomfort reports (r=+0.95, P=<0.001) with a poor correlation between theoretical and actual tight/loose fittings. CONCLUSIONS Mathematical modelling is a useful method for testing SCL design combinations. The results suggest that judicious choice of additional fittings can expand the range of fitting success.

Corneal Swelling with Cosmetic etafilcon A Lenses versus No Lens Wear

Purpose To determine if the use of pigments or adding polyvinyl pyrrolidone during the fabrication of 1-DAY ACUVUE DEFINE (AD) brand contact lenses impacts open-eye corneal swelling compared with no lens wear (NLW). Methods A partial double-masked, randomized, bilateral crossover study was conducted in 24 Asian subjects using AD, 1-DAY ACUVUE DEFINE with Lacreon (ADL), NLW, and a control lens with no tint (1-DAY ACUVUE MOIST [AM]). Central corneal thickness was measured before insertion and immediately after removal after 8 ± 1 h of open-eye wear using an optical pachymeter in one eye. Corneal thickness along a 10-mm cord was measured in the contralateral eye using the Visante optical coherence tomographer (OCT). Corneal swelling was tested for noninferiority using a 5% margin. The endothelial bleb response was measured at baseline and 20 min after lens insertion using specular microscopy. Subjective grading of corneal staining and limbal/bulbar hyperemia were also monitored. Results After 8 ± 1 h of open-eye wear, central corneal swelling across the study lenses with either optical pachymeter or OCT methods was negligible. Peripheral corneal swelling least-square mean differences with OCT were −0.03% (95% confidence interval [95% CI], −0.65 to 0.58%) and −0.26% (95% CI, −0.87 to 0.36%) between AD and ADL and the control lens (AM), respectively, and 1.67% (95% CI, 1.06 to 2.29%) and 1.45% (95% CI, 0.84 to 2.06%) between AD and ADL and NLW, respectively. No endothelial blebs were observed. No clinically significant differences were distinguished between the lenses and NLW for corneal staining and limbal/bulbar hyperemia. Conclusions After 8 ± 1 h of open-eye wear, central and peripheral corneal swelling along the horizontal meridian with AD, ADL, AM, and NLW were equivalent. These results confirm that the addition of polyvinyl pyrrolidone or pigments to etafilcon A to obtain a limbal ring design have no impact on corneal swelling or limbal/bulbar hyperemia during normal open-eye wear.

Characterizing Contact Lens-Related Corneal Infiltrates: A Pilot Study.

Purpose: To document the time course and resolution of contact lens–related corneal infiltrative events (CIEs) comparing slit-lamp images with anterior segment ocular coherence tomography (AS-OCT) images. Methods: Six silicone hydrogel (SiHy) soft contact lens (SCL) wearers presenting with newly diagnosed symptomatic CIEs were monitored with slit-lamp images, detailed drawings, and AS-OCT until the resolution of the CIE. A final follow-up visit was completed 4 weeks after CIE resolution to determine whether scar formation was present. Positive controls were 2 SiHy SCL wearers with established (inactive) corneal scars, and negative controls were 2 SiHy SCL wearers with clear corneas. High- and low-contrast logMAR visual acuities were measured, and subjective symptom questionnaires were completed at all visits. Results: Clinical signs, vision, and symptoms improved in tandem with the resolution of the CIEs as measured by imaging methods. Calibrated measures of infiltrate width from a slit-lamp biomicroscope appear to be similar to calibrated images from AS-OCT. Conclusions: Although further studies are needed to develop standardized procedures, AS-OCT can be a useful tool to characterize the development, progression, and resolution of corneal infiltrates as an objective measure of resolution and scar formation.

Resultant vertical prism in toric soft contact lenses.

PURPOSE Rotational stability of toric soft contact lenses (TSCLs) is achieved using a range of designs. Designs utilising prism or peripheral ballast may result in residual prism in the optic zone. This study quantifies the vertical prism in the central 6mm present in TSCLs with various stabilisation methods. METHOD Vertical prism was computed using published refractive index and vertical thickness changes in the central optic zone on a full lens thickness map. Thickness maps were measured using scanning transmission microscopy. Designs tested were reusable, silicone hydrogel and hydrogel TSCLs: SofLens(®) Toric, PureVision(®)2 for Astigmatism, PureVision(®) Toric, Biofinity(®) Toric, Avaira(®) Toric, clariti(®) toric, AIR OPTIX(®) for ASTIGMATISM and ACUVUE OASYS(®) for ASTIGMATISM; with eight parameter combinations for each lens (-6.00DS to +3.00DS, -1.25DC, 90° and 180° axes). RESULTS All TSCL designs evaluated had vertical prism in the optic zone except one which had virtually none (0.01Δ). Mean prism ranged from 0.52Δ to 1.15Δ, with three designs having prism that varied with sphere power. Vertical prism in ACUVUE OASYS(®) for ASTIGMATISM was significantly lower than all other TSCLs tested. CONCLUSIONS TSCL designs utilising prism-ballast and peri-ballast for stabilisation have vertical prism in the central optic zone. In monocular astigmats fitted with a TSCL or those wearing a mix of toric designs, vertical prism imbalance could create or exacerbate disturbances in binocular vision function. Practitioners should be aware of this potential effect when selecting which TSCL designs to prescribe, particularly for monocular astigmats with pre-existing binocular vision anomalies, and when managing complaints of asthenopia in monocular astigmats.

Analysis of polyvinyl alcohol release from commercially available daily disposable contact lenses using an in vitro eye model: Phan ET AL. EVALUATING THE RELEASE OF PVA FROM CONTACT LENSES

Abstract The purpose of this work was to determine the release of polyvinyl alcohol (PVA) from etafilcon A, omafilcon A, and nelfilcon A daily disposable hydrogel contact lenses using a novel in vitro model. PVA is an ocular lubricant that can be found in multiple formulations of artificial tears. Nelfilcon A innately contains PVA, so only the release of PVA from this lens was evaluated. Etafilcon A and omafilcon A lenses were incubated in a PBS solution containing PVA. The release of PVA was evaluated using a novel in vitro blink platform with Milli‐Q water and PBS under various blink conditions and flow rates. Nelfilcon A lenses significantly released more PVA than other lenses at 0.5 and 1.5 h in both PBS and Milli‐Q water (p < 0.001). For nelfilcon A, there was no statistical significance between the release profiles of PVA between the blink and no‐blink conditions, or for the various flow rates (p > 0.05). All tested groups and lenses showed a burst release within the first 4.5 h and rapidly plateaued thereafter. The current study demonstrates that releasable PVA (whether through uptake or through being inherently available from the material) is loosely bound on hydrogel lenses, and the majority is released within 4.5 h.

Determination of the release of PEG and HPMC from nelfilcon A daily disposable contact lenses using a novel in vitro eye model

Abstract The traditional method to measure release of components from CLs is a vial containing a static volume of PBS (phosphate buffered saline). However, this model does not simulate physiologically relevant tear volume and natural tear flow, air exposure, and mechanical rubbing. These factors can significantly impact release kinetics. We have developed an in vitro eye model (OcuFlow) that simulates these parameters. The aim of the study was to measure the release of PEG (polyethylene glycol), and HPMC (hydroxypropyl methylcellulose) from a daily disposable hydrogel contact lens material (nelfilcon A; Dailies AquaComfort PLUS; DACP;) over 24 hrs using the OcuFlow platform. The elution of PEG and HPMC from DACP lenses was analyzed using LCMS (liquid chromatography mass spectrometry). The release of all wetting agents from the lenses followed a burst release pattern, which occurred within the first 1.5 hrs (P < 0.05). The release of PEG was greater than that of HPMC (P < 0.05). The amount of PEG and HPMC released at any given time was less than 1% of the amount in the blister pack solution. Our results suggest that HPMC and PEG are rapidly released from the CL.