SESSION #9 Free Papers

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1 SESSION #9 Free Papers Moderator: Craig W. Norman, FCLSA Langis Michaud, OD, MSc, FAAO; E. Simone Visser, MSc, PhD; Michel Guillon, PhD, FCOptom, FAAO; David Berntsen, OD, PhD, FAAO; Anna Sulley, BSc, MCOptom, FBCLA, FAAO; John Mountford, Dip. App. Sc., FAAO, FVCO, FCLS 1. Clinical Complications Associated with Smaller Diameter Mini scleral Lenses: A Retrospective Study i. To evaluate the rate of clinical complications associated with the prescription of a small diameter (14.6mm) mini scleral lens (SDMS) i. This was a retrospective study. Chart of every patient fitted with SDMS lenses in 2012 at Clinique Universitaire de la Vision was reviewed. Subject's files were assigned to 2 groups: keratoconus (group A) and non keratoconus patients (group B). For each group, a rate of success in the fitting process, the number of lenses to achieve an optimal fit, and the clinical complications diagnosed in the follow up visits, during 1 year, were recorded. The drop out rate was also estimated. i. A total of 113 eyes were fitted with an SDMS in Group A counted 39 eyes. The rate of successful fitting was 82%. It took 1.8 lens/eye to achieve an optimal fit and after a year, 90% of these patients still worn their lenses. The rate of clinical complication was 39%, the vast majority being associated with the presence of SPK secondary to the use of preserved saline solution to fill in the lenses. In group B, 74 eyes were fitted. It took 1.6 lenses/ eye to achieve an optimal fit and 83% of the patients remained in lenses after a year. 52% of the patients showed clinical complications: SPK as the number one issue, followed by conjunctival hyperemia, especially on patients with eye dryness. Overall there were no adverse effects related to limbal issues, except for one patient who developed neovascularization in one eye. Overall there was no statistical difference among groups. i. Over 85% of the patients were able to be fitted in SDMS and most of them remained in this modality after a year. It took almost 2 lenses / eye to achieve an optimal fit. Clinical complications occurred in half of the cases, the vast majority of them being associated with the use of preserved saline in the reservoir, leading to light SPK. There is no evidence that SDMS was associated with negative outcome in the limbal area. Based on these results, the regular use of SDMS can be considered a safe alternative for keratoconus and nonkeratoconus patients. 2. Introduction of a Medical Contact Lens Selection Algorithm

2 i. To evaluate the objective and subjective performance of medical contact lenses (CLs) fitted for a broad range of clinical indications using a lens selection algorithm. i. A total of 281 eyes were evaluated from 281 patients who visited the contact lens service at a tertiary academic clinic (Visser Contactlenzen, University Medical Center Utrecht, the Netherlands). We obtained each patient's medical history, CL history, and visual acuity; in addition, patients completed a questionnaire. i. The most common diagnoses were keratoconus (25%), dry eye disease (23%), and keratoplasty (20%); the most common CL types were scleral lenses (53%) and soft lenses (either conventional soft lenses or silicone hydrogel lenses; 35%). The lens selection algorithm was found to be generally effective, as indicated by an overall satisfaction rating >70 in 81% of patients. i. CLs fitted using the lens selection algorithm yield satisfactory clinical results, including improved visual acuity, satisfactory wearing time, and satisfactory overall subjective performance. This study underscores the importance of using scleral lenses and the need for offering a variety of CL types in tertiary eye clinics. 3. Upper Lid Margin Staining in Presbyopic Contact Lens Wearers of Asian Descent i. A challenge in fitting presbyopic patients with contact lenses is the greater underlying level of ocular tissue dryness that this population frequently exhibits; of particular concern is the severity of lid wiper staining that can occur as a result of the friction between the contact lens and upper lid margin, especially in individuals with tighter eyelids which may produce increased eye lid pressure on the region of the contact lens under the eyelid. It was hypothesized that the lid wiper tissue could be influenced by the contact lens material properties and that etafilcon A (MOIST), which achieves good wettability due to its ionic surface charge and permanently embedded wetting agent, could minimize friction that can lead to the risk of lid wiper epitheliopathy. i. Twenty established presbyopic contact lens wearers (Hydrogel n = 5, none habitual wearers of 1DAY ACUVUE MOIST; Silicone Hydrogel n =15) of Asian descent were refitted with 1DAY ACUVUE MOIST MULTIFOCAL and the effect of one month of lens wear on lid margin staining was analysed. Digital photographs of the upper lid margins were taken following six hours of wear of the participants' habitual contact lenses, following one day without contact lens wear and following six hours of wear of the test contact lenses at the end of the one month period. The photographs were masked according to study visit and the staining extent measured using OTG i proprietary software.

3 i. Lid margin staining was significantly (p = 0.010) lower with the study contact lenses (2.0 ± 1.0 mm2) than with the participants' own contact lenses (3.2 ± 3.0mm2) after six hours of wear, representing a mean staining decrease of 38%; further the most severe staining decreased by 65% (from 13.6 to 4.8 mm2) over the same period. Lid margin staining after six hours of wear of the study contact lenses was not different (p = 0.507) from that measured after one day without contact lenses. i. etafilcon A material was shown to reduce upper lid margin staining in presbyopic contact lens wearers of Asian descent, compared to other materials, particularly silicone hydrogels. Because of the high preponderance of dry eye amongst presbyopes, material selection is of importance and consideration should be given to the lens tissue interaction. 4. The Effect of Toric Versus Spherical Contact Lenses on Subjective Vision and Lens Fit Complexity in Astigmatic Patients i. To compare the effect of toric versus spherical soft contact lenses on the number of lenses required to initially fit an astigmatic patient and on subjective and objective vision. i. Sixty two habitual soft contact lens wearers with spectacle astigmatism in each eye of 0.75 to 1.75 D (corneal plane) were fitted bilaterally in random order with both spherical contact lenses (1 DAY ACUVUE MOIST) and toric contact lenses (1 DAY ACUVUE MOIST for ASTIGMATISM) on different days. At each fitting visit, the number of lenses required to achieve a successful contact lens fit (good fit and vision) was recorded. Low contrast logmar visual acuity (VA) was also measured. After wearing the lenses dispensed for 5 10 days, subjects returned and completed the National Eye Institute Refractive Error Quality of Life Instrument (NEI RQL; higher score is better) and the Convergence Insufficiency Symptom Survey (CISS; lower score is better). Linear mixed models were used to analyze the diurnal variation subscale of the NEI RQL, the CISS score, the number of lenses required to achieve a successful fit, and lowcontrast visual acuity. i. The mean age (±SD) was 27.6 ± 5.1 years, and 45 (73%) were female. Spherical refractive error was 3.62 ± 2.01 D, and cylinder was 1.26 ± 0.38 D. There was no difference between the sphere and toric in the number of contact lenses required to achieve a successful fit (least square (LS) mean = 1.2 lenses for sphere and 1.2 lenses for toric; p = 0.30). With spherical lenses, 80% of eyes were fitted successfully with the first lens selection, and 85% of eyes were fitted successfully with the first toric lens selected. LS mean low contrast VA was better with toric lenses (0.11) than spherical lenses (0.21) (difference = 0.10; p < ). The diurnal fluctuations subscale of the NEI RQL was significantly better with toric lenses (LS mean ± SE = 81.0 ± 2.9) than with spherical lenses

4 (74.3 ± 2.6; p = 0.02), indicating a 9% reduction in subjective diurnal fluctuations when wearing toric lenses versus spherical lenses. The LS mean (±SE) CISS score was also significantly better with toric lenses (12.3 ± 1.1) than spherical lenses (14.3 ± 1.1; p = 0.02), indicating an improvement with toric lenses. i. There was no difference in the number of diagnostic lenses required to successfully fit subjects with toric versus spherical lenses. Toric contact lenses provided better subjective and objective vision. These results support the use of toric lenses even in patients with low to moderate amounts of astigmatism. 5. Practitioner and Patient Experience with a New Multifocal Contact Lens in a Large Scale Study i. An aspheric, center near multifocal lens (MFCL), with design optimized for add and refractive error and aspheric/spherical back surface to maintain centration, has been clinically shown to deliver a high fitting success with a simple fit process and provide good vision at all distances, with consistent performance across refractive and add powers. A large scale, multi center study was conducted to identify performance, satisfaction and behavior change with the daily disposable MFCL (etafilcon A). i. A two month assessment was completed in US & UK with practitioners (ECPs) fitting patients with the new CL using its fit guide. Performance and success data were gathered from ECP online surveys (pre & post study) and initial & follow up visit fit experience data. Data were collated and analyzed by an independent market research agency. i. ECPs (n=234) fit 1,993 patients (pxs) in practice; 1,537 completed experience logs at follow up after a trial period. Mean px age was 54 yrs and 77% were female; 69% were myopic, 23% hyperopic and 9% emmetropic. 24% were neophytes and 76% current CL wearers (of which 47% wore a MFCL and 23% monovision; brands were market representative). The fit guide was used by 79% ECPs and partially used by 18%; fewer trial lenses were used when following the fit guide (1.3 vs 1.6 partially/not used at all, p<0.05). Use of the fit guide also led to a higher likelihood to trial (93% vs 89%), plus higher ratings for overall vision (89% vs 84%) and near vision (83% vs 76%) (all p<0.05). On initial fitting, 1.4 CLs were needed to complete fit and 95% were dispensed with trial lenses. At follow up, 77% pxs returned (demographics similar to original sample) and 1.8 visits were needed for final fit after trial (mean trial length 5.4 days, SD ±1.66); 68% of those who returned purchased the CLs. From the experience log, 83% were successful on follow up; majority needed no adjustment at follow up visit. Pxs were highly satisfied with the lenses; ratings were 85% for overall vision and 93% for comfort. In the post study survey, ECPs agreed fewer visits were needed to fit the new MFCL compared to other MFCLs (2.0 vs 2.5, p<0.05) and that it delivered a high success rate with the first pair. ECPs were highly

5 satisfied with the CL excellent overall vision performance (93%) and provision of excellent comfort (all day 99%, end of day 96%). ECP success rate in fitting MFCLs prior to the study was rated as 63%; this increased to 78% with the new CL (and compared to 90% & 87% for fitting their preferred spherical & toric lenses respectively). Where ECP MF success rate prior to the study was 75% (82% agreed), they were more likely to indicate the new CL was the easiest MF CL to fit compared to those with a high success rate (59% agree, p<0.05). Nearly all (99%) would recommend the CL to colleagues and it was rated easy for patients to adapt to (97%). Based on experience with the lens, 84% of ECPs agreed they are highly likely to fit presbyopes with the lens, 65% highly likely to fit spherical CL wearers earlier than previously, and 65% are less likely to fit monovision. There were no adverse events during the study. i. The results corroborate clinical study data with high success and satisfaction rates, minimal chair time and ease of fit, in particular with the aid of the fitting guide. This led ECPs to anticipate fitting more MFCLs to all patient types with the lens. While high success amongst all groups, those most successful were existing CL wearers. Patient success may also be linked to a longer trial period. 6. The ICD: An Analysis of the First 394 cases i. To determine the first fit success rate and the reasons for lens exchanges in a large group of patients fitted with the Paragon ICD Mini scleral lens i. A retrospective analysis of the first 394 patients fitted with the lens to determine a) first fit success rate b) the most common parameter changes made on exchange, c) the number of exchanges required to achieve a successful fit and d) the incidence of manufacturing errors and overall quality control. Keratoconus and PMD accounted for 63% of the cases, whilst 28% were post graft and 9% Ocular Surface Disease. i. The first fit success rate was 63.5% In the exchange group, 76% were successfully fitted with 1 exchange, 23% required 2 exchanges and 1% required 3 or more exchanges to achieve success. There were 14 unsuccessful patients and a further 12 lost to follow up. The most common parameter changes were. 1. Increased sag by steepening the BOZR (mean 108 +/ 98um)24% 2.Steepening PCCZ (mean 85+/ 58um): 14% 3 Steepening LCCZ (mean 104+/ 58um):23% 4 Power Change ( 0.79+/ 1.61D): 17% The overall quality of manufacture was excellent i. The most common cause for re makes is lens settling leading to insufficient apical and limbal clearance.