Publications by authors named "Sheila Hickson-Curran"

Purpose: Microperimetry (MP) allows for measurement of retinal sensitivity at precise locations and is now commonly employed as a clinical trial endpoint. Test-retest reliability is important when evaluating treatment effects in patients with geographic atrophy (GA). This study aimed to determine the test-retest variability of MP in patients with moderate to severe GA using the MAIA MP device.

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Purpose: To evaluate safety and successful use of a novel subretinal delivery system and suprachoroidal surgical approach and safety and activity of human umbilical tissue-derived cells (palucorcel) via a novel delivery system in patients with geographic atrophy (GA).

Design: Multicenter, open-label phase 2b study.

Participants: Participants were 55 to 90 years with GA secondary to age-related macular degeneration (AMD) and best-corrected visual acuity (BCVA) of 20/80 to 20/800.

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Purpose: To evaluate lid wiper epitheliopathy (LWE) in soft contact lens (SCL) wearers on initial presentation and after using various SCL and solution combinations.

Methods: LWE was assessed in 253 habitual SCL wearers who attended a screening visit at one of three study sites. LWE was assessed using lissamine green and sodium fluorescein dyes (Korb scale); a final LWE grade was calculated as the averaged LWE grade of the two dyes.

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Purpose: To compare subjective comfort and ocular physiology with three multipurpose solutions (MPSs) to that of a peroxide-based system with three different soft contact lens materials.

Methods: Habitual soft contact lens wearers (n = 236) were enrolled at three sites and completed a washout period with no contact lens solution for ≥4 days. Subjects were randomly assigned to one of three lens types: etafilcon A, galyfilcon A, or senofilcon A.

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Purpose: To describe the lid margin characteristics of contact lens wearers and relate them to comfort during lens wear.

Methods: Three study sites enrolled habitual contact lens wearers. Subjects completed the Comfort domain of the Contact Lens User Experience (CLUE) questionnaire, and each eye was graded for the presence of mucocutaneous junction (MCJ) displacement, lid margin irregularity, and lid margin vascularity.

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Objectives: To describe the patient-reported wearing experience over time among wearers of hydrogel daily disposable (HydDD) contact lenses (CLs) in the TruEye and Moist Performance Overview (TEMPO) Registry (NCT01467557).

Methods: Registered wearers older than 40 years who were recently fit with 1-DAY ACUVUE MOIST HydDDs completed self-administered questionnaires four times during a year-long Registry. Overall opinion of CLs, replacement schedules, Contact Lens Dry Eye Questionnaire (CLDEQ-8), and compliance were queried.

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Purpose: To report (1) results of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) among a large sample of SCL wearers before and during 1 year after fitting with one of 2 daily disposable (DD) lenses (etafilcon A or narafilcon B) in the TEMPO Registry, (2) the cut-off score to identify highly symptomatic SCL wearers and (3) the clinically important difference (CID) in the CLDEQ-8 score.

Methods: Demographics, CL history and patterns of SCL use were documented. Construct validity of the CLDEQ-8 was tested versus overall opinion (OO) of habitual SCLs, eye dryness and eye sensitivity at baseline.

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Background: The aim was to evaluate the effect of ocular topography on soft contact lens fit in Chinese and Caucasians.

Method: This study evaluated 547 subjects from two ethnic groups, Caucasian (n = 250) and Chinese (n = 297), at investigational sites in three locations: Wenzhou, China, Melbourne, Australia and Jacksonville, USA. Subjects underwent measurement of a range of ocular topographic variables using identical equipment and protocols, including: apical corneal radius (CR), corneal shape factor (CSF) in the two principal meridians, horizontal visible iris diameter (HVID), vertical palpebral aperture (PA), upper lid angle (ULA) and inter-canthal angle (ICA).

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Purpose: To report annualized adverse events (AEs) including corneal infiltrative events (CIEs) with use of silicone hydrogel (SiHyDD) and hydrogel daily disposable (HydDD) soft contact lenses (SCLs) in the 1•DAY ACUVUE TruEye or 1•DAY ACUVUE MOIST Performance Overview (TEMPO) Registry (NCT01467557).

Methods: Annualized incidence of symptomatic daily disposable (DD)-related AEs was calculated from 3064 surveys from 1171 subjects (601 SiHyDD and 570 HydDD, 31.8 ± 13.

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Purpose: To provide comparative ocular topography data from a substantial population of East Asian and white eyes.

Methods: This study evaluated 675 subjects from three ethnic groups: white (n = 255), Chinese (n = 299), and Japanese (n = 121) at investigational sites in four locations: Wenzhou, China; Melbourne, Australia; Tokyo, Japan; and Jacksonville, USA. Subjects underwent the same measurements of ocular topography using identical equipment and protocols.

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Purpose: Replacing soft contact lenses (CLs) on a daily basis brings a number of advantages, most notably, reduced exposure to deposits, disinfectants, allergens, and other contaminants. This retrospective study estimated the prevalence of problems in current wearers of reusable soft CLs and tested the effect of refitting "problem" patients with daily disposable (DD) hydrogel lenses.

Methods: Prevalence was estimated from 398 current reusable CL wearers for: frequent/constant discomfort or dryness, ≥2 h of uncomfortable wear, ≥grade 2 conjunctival hyperaemia (0-4), or ≥grade 3 corneal staining (0-15).

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Purpose: To estimate the prevalence of self-reported "sensitive eyes" (SEs) in soft contact lens (CL) wearers, evaluate the clinical characteristics of patients with SEs, and examine the effect of refitting them with silicone hydrogel lenses.

Methods: After self-assessment, 2154 CL wearers were separated into SE and non-SE patients. Demographics, biometric data, wearing time, symptoms, and signs were compared between the two populations.

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Purpose: To report on the development and validation of a short form of the Contact Lens Dry Eye Questionnaire (the CLDEQ-8) to enable it to reflect status of and change in overall opinion ("opinion") of soft contact lenses (SCLs).

Methods: Item reduction for the CLDEQ was achieved by correlation with overall opinion of SCLs at follow-up visits in a sample of 38 SCL wearers at one academic clinical site. The CLDEQ-8 score (frequency plus late day intensity of dryness, discomfort, and "blurry vision"; frequency of "closing eyes to rest them" and "removing CLs to relieve discomfort") was then tested in 379 SCL wearers in a multicenter study with analysis stratified by opinion ratings at baseline and 2 weeks postrandomization to new silicone hydrogel SCLs.

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Purpose: To review important aspects of contact lens compliance and to survey contact lens replacement frequency, steps in lens care and hygiene and replacement of the lens storage case via online surveys.

Methods: Random US samples (n=645 and 787) of frequent replacement contact lens wearers answered questions on contact lens wear in online, sponsor-masked surveys.

Results: Wearers of lenses prescribed by their practitioner for 2 weekly replacement reported that they replaced lenses as follows: within 2 weeks 45%, within 3 weeks (minor stretching) 68%, within 4 weeks 89%, ≥8 weeks (extreme stretching) 4%, compared to Monthly wearers who reported: within 4 weeks 37%, within 5 weeks (minor stretching) 57%, ≥8 weeks 23% (≥8 weeks extreme stretching, Chi-square p=0.

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Purpose: To report the symptoms and experiences associated with habitual hydrogel (Hyd) and silicone hydrogel (SiHy) contact lenses (CLs) among young adults and measure their association with age.

Methods: Questionnaire responses from 699 Hyd and 183 SiHy wearers were analyzed to test the association of age with features indicating struggle with CL wear. Prevalence by age was compared between groups with Pearson's chi-square and within groups with Spearman's correlation coefficient.

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Purpose: The manufacturing variability of frequent replacement toric soft lenses is such that some resulting variation in clinical performance can be expected. The purpose of this study was to evaluate the effect of manufacturing variability on the clinical performance of three frequent replacement toric soft contact lenses.

Methods: This was a three-part study in which 12 to 14 subjects were enrolled for each part.

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