PURPOSE:

This retrospective multicentre case review documented real-world visual outcomes, lens fitting practices, and eyecare practitioner (ECP) satisfaction with Zenlens, a custom scleral lens (SL). Here, ECP satisfaction outcomes are presented.

METHODS:

SL-experienced ECPs from Canada, Ireland, and the USA used a standardised case report form (CRF) to provide a deidentified retrospective convenience sample of ≥5 cases, including ≥3 complex cases, with a range of customisations. ECPs reported their overall satisfaction with lens outcomes, and the degree, process, and ease of customisation. Central IRB exemption was received. Descriptive statistics are reported.

RESULTS:

Nine ECPs completed the ECP satisfaction section of the CRF. Mean±SE years of ECP SL experience was 14±2 years. The retrospective chart review included 45 patients (62 eyes). SLs were fitted in both eyes in 17 patients, OS in 13 patients, and OD in 15 patients. The most common diagnosis was keratoconus (42/62 eyes); other reasons for SL utilisation included high/irregular astigmatism and other corneal disease resulting in corneal irregularities. All ECPs rated satisfaction with lens outcomes, degree of lens customisation, and lens customisation process as either 8 (n=1/56 eyes; 2/56 eyes; 2/55 eyes, respectively), 9 (n=6/56 eyes; 5/56 eyes; 3/55 eyes, respectively), or 10 (n=49/56 eyes; 49/56 eyes; 50/55 eyes, respectively) [0, very dissatisfied; 10, very satisfied]. Fit, vision outcomes, and patient satisfaction were the most cited reasons for satisfaction. All ECPs rated the process of SL customisation as either 8 (n=5/56 eyes), 9 (n=9/56 eyes), or 10 (n=42/56 eyes) [0, very difficult; 10, very easy]. ECPs did not provide satisfaction ratings for all domains/patients/eyes, accounting for the variation in responses.

CONCLUSION:

This case review provided insights into the real-world utilisation of this customisable SL; it demonstrated high levels of ECP satisfaction with lens outcomes, degree of lens customisation, and the lens customisation process in patients with various corneal conditions.

PURPOSE:

Kalifilcon A (INFUSE/ULTRA One Day) multifocal silicone hydrogel daily disposable contact lenses (CLs) incorporate technology inspired by the Tear Film & Ocular Surface Society’s Dry Eye Workshop II Report and a three-zone progressive design to improve near and intermediate vision. The present analysis assessed fitting success in a multicenter clinical study conducted to evaluate the performance this CL.

METHODS:

Patients ≥40 years of age who were habitual wearers of soft multifocal contact lenses were enrolled in a prospective, single-arm, bilateral, open-label study conducted by investigators at 20 sites in the United States. All eligible subjects completed a screening/dispensing visit where they received study contact lenses for wear (3 weeks), with scheduled in-office follow-up visits at 1 week and 3 weeks. Investigators also completed a questionnaire (6-point Likert scale) at each subject’s study exit visit. A one-sided exact binomial test was used to evaluate rates of agreement with each questionnaire statement (hypothesis of agreement proportion >50%).

RESULTS:

Substantial proportions of the 294 subjects in this study (mean age 53.9 years; 78.2% female) were successfully fit with this lens in one visit (87.4%, screening/dispensing) or two visits (99.0%, screening/dispensing+1 week follow-up). By eye, these proportions with successful fits were 91.4% and 99.0%, respectively. At the screening/dispensing visit, 93.0% of eyes and 89.5% of subjects required no lens refinement to achieve a successful fit, with consistent findings at 1 week. Across all visits, 85.9% of eyes required no lens refinement. In the study investigator questionnaire, practitioners also expressed agreement that the fitting process was straightforward for all (100%) subjects (p <0.0001), with nearly two thirds 67.8 even strongly agreeing with this statement.>

CONCLUSION:

This multifocal silicone hydrogel daily disposable CL demonstrated strong fitting performance in a variety of subjects, as evidenced by both fitting success rates and practitioner responses.

PURPOSE: Evaporation and renewal of the tear film can be altered by multiple factors, and restoring a functional tear film in dry eye disease can be a complex challenge. Traditionally, dry eye relief has been provided by water-based artificial tears (ATs), but ATs with lipid components have emerged more recently to provide lubrication while decreasing tear evaporation. This study compared the performance and safety of two preservative-free ATs with sodium hyaluronate (SH) in patients with moderate-to-severe dry eye disease: a multicomponent 0.24% SH eye drop with carbomer and triglycerides as lipids (SH-CB-TG), and an aqueous-based comparator (C-SH) with 0.18% SH.

METHOD: In this multicentre, investigator-masked, noninferiority study, patients were randomised to SH-CB-TG or C-SH, administered 3–6 times daily for 3 months. The primary endpoint was change from baseline in the ocular surface fluorescein staining (OSFS) score (0–15 per the Oxford scheme) at Day 28 in the per-protocol population. Secondary endpoints included OSFS at 3 months, tear film break-up time, dry eye symptoms, quality-of-life questionnaire and frequency of AT instillation.

RESULTS: On Day 28, OSFS score decreased from a baseline of 5.7±1.2 to 3.6±1.6 in the SH-CB-TG group (n=45), while in the C-SH group (n=34), it decreased from 5.8±1.3 to 4.3±2.1 (95% confidence interval of the adjusted difference was below the predetermined value for noninferiority). In both groups, signs, symptoms and quality-of-life measures improved continuously through the study, with a favourable safety profile. In the SH-CB-TG group, the global score of dry eye symptoms showed a statistically significant improvement compared with the C-SH group (p<0.05).>

CONCLUSIONS: The multicomponent, lipid-containing SH-CB-TG was noninferior to the aqueous-based tear substitute in terms of ocular staining in the studied population, and may offer additional advantage in ameliorating symptoms of dry eye.

PURPOSE:

Scleral profilometry shows the sclera is spherical in shape for only 5.7% of eyes. A customizable scleral lens (SL), Zenlens, is available, which incorporates extensive customization for a precise fit in patients with a variety of corneal irregularities. Bi-Elevation technology creates two sagittal depth values inside the vaulting chamber to address scleral and limbal asymmetry, enabling uniform landing on the sclera. The purpose of this retrospective case review was to describe the real-world utilization of this SL; this sub-analysis focused on customization with Bi-Elevation.

METHODS:

Ten eye care practitioners (ECPs) from three countries provided a deidentified retrospective convenience sample of ≥5 cases using a standardized case report form (CRF), including ≥3 complex cases with a range of customizations. Data collected included best-corrected visual acuity (BCVA), comfortable wearing time, ocular symptoms, ECP satisfaction, lens fitting patterns, and number of follow-up visits required to achieve a successful fit. The protocol received central institutional review board exemption. Descriptive statistics are reported.

RESULTS:

The full analysis set included all submitted CRFs from 10 ECPs (62 eyes; 45 patients). CRFs from six ECPs (23 eyes; 18 patients: 50% female; 50% male) utilizing Bi-Elevation, among other customizable parameters, were included in the present sub-analysis. The most common diagnosis was keratoconus (17/23 eyes); other reasons for SL utilization included high astigmatism and other corneal irregularities. The mean (SD) horizontal and vertical sagittal depth values were 4795 (409) and 5092 (448), respectively. A BCVA of 20/25 or better was achieved in 78% of cases (18/23 eyes). A mean (SD) comfortable wearing time of 13 (4) h was reported.

CONCLUSION:

This sub-analysis provided valuable insights into the fitting practices and visual outcomes with this customizable SL. The results demonstrated the utility of Bi-Elevation technology in enabling a precise fit in eyes with differences in elevation between the two major meridians.

PURPOSE:

Kalifilcon A (INFUSE/ULTRA One Day; UOD) contact lenses (CLs) are daily disposable silicone hydrogel CLs that are uniquely inspired by the Tear Film & Ocular Surface Society’s Dry Eye Workshop II Report and designed to improve wearer comfort. The present work assessed satisfaction of existing wearers of planned replacement soft CLs (PRSCLs), and their eyecare professionals (ECPs), following a trial of UOD spherical CLs.

METHODS:

A total of 9577 patients (18–44 years of age) were fitted with UOD CLs by 1308 ECPs from 11 European countries in this survey study. Eligible patients were either new to CL wear or existing CL wearers (including silicone hydrogel/hydrogel daily disposable CLs, or PRSCLs [monthly/biweekly]). A standardized questionnaire was used to gather patient information and assess patient and ECP experience following the trial.

RESULTS:

Approximately half of the patients were existing CL wearers; of these, 29% were PRSCL wearers. The questionnaire included three key study attributes, overall comfort, clear vision, and ease of handling, with patients in this cohort reporting high satisfaction: 91%, 90%, and 92%, respectively. Of the PRSCL wearer cohort, 88% of were overall satisfied following their experience with UOD CLs (37% satisfied, 51% very satisfied) and approximately two-thirds of existing PRSCL wearers agreed that UOD CLs were superior to their previous CL (69% agreed they could wear UOD CLs for longer; 64% agreed that UOD CLs were better lenses). 92% of participating ECPs were very satisfied (40%) or satisfied (52%) with results obtained with UOD CL for their patients, and 96% considered UOD CL easy to fit; 91% were very likely (38%) or likely (53%) to recommend the CL to other ECPs.

CONCLUSION:

Patients and ECPs reported high overall satisfaction. A majority of existing PRSCL wearers preferred this daily disposable modality CL to their previous CL, and ECPs were likely to recommend the CL to other ECPs.