Six-year cumulative treatment effect and treatment efficacy of a dual focus myopia control contact lens.

PURPOSE: Accumulated axial growth observed during a 6-year clinical trial of a dual focus myopia control contact lens was used to explore different approaches to assess treatment efficacy. METHODS: Axial length measurements from 170 eyes in a 6-year clinical trial of a dual focus myopia control lens (MiSight 1 day, CooperVision) were analysed. Treatment groups comprised one having undergone 6 years of treatment and the other (the initial control group) having 3 years of treatment after 3 years of wearing a single vision control lens. Efficacy was assessed by comparing accumulated ocular growth during treatment to that expected of untreated myopic and emmetropic eyes. The impact of treatment on delaying axial growth was quantified by comparing the increased time required to reach criterion growths for treated eyes and survivor analysis approaches. RESULTS: When compared to the predicted accumulated growth of untreated eyes, 6 years of treatment reduced growth by 0.52 mm, while 3 years of treatment initiated 3 years later reduced growth by 0.19 mm. Accumulated differences between the growth of treated and untreated myopic eyes ranged between 67% and 52% of the untreated myopic growth, and between 112% and 86% of the predicted difference in growth between untreated myopic and age-matched emmetropic eyes. Treated eyes took almost 4 years longer to reach their final accumulated growth than untreated eyes. Treatment increased the time to reach criterion growths by 2.3-2.7 times. CONCLUSION: Estimated growth of age-matched emmetropic and untreated myopic eyes provided evidence of an accumulated slowing in axial elongation of 0.52 mm over 6 years, and the treated growth remained close to that expected of emmetropic eyes. Six years of dual focus myopia control delayed the time to reach the final growth level by almost 4 years.

Myopia Control Dose Delivered to Treated Eyes by a Dual-focus Myopia-control Contact Lens.

PURPOSE: This study examined the optical impact of a DF contact lens during near viewing in a sample of habitual DF lens wearing children. METHODS: Seventeen myopic children aged 14 to 18 years who had completed 3 or 6 years of treatment with a DF contact lens (MiSight 1 Day; CooperVision, Inc., San Ramon, CA) were recruited and fit bilaterally with the DF and a single-vision (Proclear 1 Day; CooperVision, Inc.) contact lens. Right eye wavefronts were measured using a pyramidal aberrometer (Osiris; CSO, Florence, Italy) while children accommodated binocularly to high-contrast letter stimuli at five target vergences. Wavefront error data were used to compute pupil maps of refractive state. RESULTS: During near viewing, children wearing single-vision lenses accommodated on average to achieve approximate focus in the pupil center but, because of combined accommodative lag and negative spherical aberration, experienced up to 2.00 D of hyperopic defocus in the pupil margins. With DF lenses, children accommodated similarly achieving approximate focus in the pupil center. When viewing three near distances (0.48, 0.31, and 0.23 m), the added +2.00 D within the DF lens treatment optics shifted the mean defocus from +0.75 to -1.00 D. The DF lens reduced the percentage of hyperopic defocus (≥+0.75 D) in the retinal image from 52 to 25% over these target distances, leading to an increase in myopic defocus (≤-0.50 D) from 17 to 42%. CONCLUSIONS: The DF contact lens did not alter the accommodative behavior of children. The treatment optics introduced myopic defocus and decreased the amount of hyperopically defocused light in the retinal image.

Long-term Effect of Dual-focus Contact Lenses on Myopia Progression in Children: A 6-year Multicenter Clinical Trial.

SIGNIFICANCE: Treatment of myopic children with a dual-focus soft contact lens (DFCL; MiSight 1 day) produced sustained slowing of myopia progression over a 6-year period. Significant slowing was also observed in children switched from a single vision control to treatment lenses (3 years in each lens). PURPOSE: This study aimed to evaluate the effectiveness of DFCLs in sustaining slowed progression of juvenile-onset myopia over a 6-year treatment period and assess myopia progression in children who were switched to a DFCL at the end of year 3. METHODS: Part 1 was a 3-year clinical trial comparing DFCLs with a control contact lens (Proclear 1 day) at four investigational sites. In part 2, subjects completing part 1 were invited to continue for 3 additional years during which all children were treated with MiSight 1 day DFCLs (52 and 56 from the initially treated [T6] and control [T3] groups, respectively). Eighty-five subjects (45 [T3] and 40 [T6]) completed part 2. Cyclopleged spherical equivalent refractive errors (SEREs) and axial lengths (ALs) were monitored, and a linear mixed model was used to compare their adjusted change annually. RESULTS: Average ages at part 2 baseline were 13.2 ± 1.3 and 13.0 ± 1.5 years for the T6 and T3 groups, respectively. Slowed myopia progression in the T6 group observed during part 1 was sustained throughout part 2 (mean ± standard error of the mean: change from baseline SERE [in diopters], -0.52 ± 0.076 vs. -0.51 ± 0.076; change in AL [in millimeters], 0.28 ± 0.033 vs. 0.23 ± 0.033; both P > .05). Comparing progression rates in part 2 for the T6 and T3 groups, respectively, indicates that prior treatment does not influence efficacy (SERE, -0.51 ± 0.076 vs. -0.34 ± 0.077; AL, 0.23 ± 0.03 vs. 0.18 ± 0.03; both P > .05). Within-eye comparisons of AL growth revealed a 71% slowing for the T3 group (3 years older than part 1) and further revealed a small subset of eyes (10%) that did not respond to treatment. CONCLUSIONS: Dual-focus soft contact lenses continue to slow the progression of myopia in children over a 6-year period revealing an accumulation of treatment effect. Eye growth of the initial control cohort with DFCL was slowed by 71% over the subsequent 3-year treatment period.

Optic nerve biopsy in leukemic infiltrative optic neuropathy: a case report and review of the literature.

Optic nerve infiltration is a rare but known complication of the central nervous system (CNS)-involving lymphoma and leukemic disorders. The diagnosis is often presumed and patients are empirically treated with systemic therapy and/or local radiation. Optic nerve biopsy is usually avoided due to the risk of permanent vision loss secondary to the procedure. We present a case of biopsy-proven leukemic optic neuropathy without optic nerve sheath or cerebrospinal fluid (CSF) involvement in a patient previously in remission from T-cell prolymphocytic leukemia (T-PLL). To our knowledge, this is the first documented case of T-PLL with biopsy-proven optic nerve invasion without CSF involvement and suggests possible perineural invasion or a sanctuary site from chemotherapy. We suggest that for patients with poor vision and suspected leukemic infiltration without other evidence of CNS involvement, both optic nerve and optic sheath biopsy should be performed for diagnosis and treatment.

Axial length targets for myopia control.

PURPOSE: Both emmetropic and myopic eyes elongate throughout childhood. The goals of this study were to compare axial elongation among untreated progressing myopes, progressing myopes treated with a myopia control contact lens and emmetropes, in order to place axial elongation in the context of normal eye growth in emmetropic children, and to consider whether normal physiological eye growth places limits on what might be achieved with myopia control. METHODS: Axial elongation data were taken from the 3-year randomised clinical trial of a myopia control dual-focus (MiSight® 1 day) contact lens. These were compared with data for myopic and emmetropic children in two large cohort studies: the Orinda Longitudinal Study of Myopia (OLSM) and the Singapore Cohort Study of the Risk Factors for Myopia (SCORM). Each study's published equations were used to calculate annual axial elongation. Four virtual cohorts-myopic and emmetropic for each model-were created, each with the same age distribution as the MiSight clinical trial subjects and the predicted cumulative elongation calculated at years 1, 2 and 3 for myopes and emmetropes using both the OLSM and SCORM models. RESULTS: The untreated control myopes in the MiSight clinical trial showed mean axial elongation over 3 years (0.62 mm) similar to the virtual cohorts based on the OLSM (0.70 mm) and SCORM (0.65 mm) models. The predicted 3-year axial elongation for the virtual cohorts of emmetropes was 0.24 mm for both the OLSM and SCORM models-similar to the mean 3-year elongation in MiSight-treated myopes (0.30 mm). CONCLUSIONS: The 3-year elongation in MiSight-treated myopes approached that of virtual cohorts of emmetropes with the same age distribution. It is hypothesised that myopic axial elongation is superimposed on an underlying physiological axial elongation observed in emmetropic eyes, which reflects increases in body stature. We speculate that optically based myopia control treatments may minimise the myopic axial elongation but retain the underlying physiological elongation observed in emmetropic eyes.

Adverse event rates in the retrospective cohort study of safety of paediatric soft contact lens wear: the ReCSS study.

PURPOSE: To ascertain the safety of soft contact lens (SCL) wear in children through a retrospective chart review including real-world clinical practice settings. METHODS: The study reviewed clinical charts from 963 children: 782 patients in 7 US eye care clinics and 181 subjects from 2 international randomised clinical trials (RCTs). Subjects were first fitted while 8-12 years old with various SCL designs, prescriptions and replacement schedules, and observed through to age 16. Clinical records from visits with potential adverse events (AEs) were electronically scanned and reviewed to consensus by an Adjudication Panel. RESULTS: The study encompassed 2713 years-of-wear and 4611 contact lens visits. The cohort was 46% male, 60% were first fitted with daily disposable SCLs, the average age at first fitting was 10.5 years old, with a mean of 2.8 ± 1.5 years-of-wear of follow-up observed. There were 122 potential ocular AEs observed from 118/963 (12.2%) subjects; the annualised rate of non-infectious inflammatory AEs was 0.66%/year (95% CI 0.39-1.05) and 0.48%/year (0.25-0.82) for contact lens papillary conjunctivitis. After adjudication, two presumed or probable microbial keratitis (MK) cases were identified, a rate of 7.4/10 000 years-of-wear (95% CI 1.8-29.6). Both were in teenage boys and one resulted in a small scar without loss of visual acuity. CONCLUSION: This study estimated the MK rate and the rate of other inflammatory AEs in a cohort of SCL wearers from 8 through to 16 years of age. Both rates are comparable to established rates among adults wearing SCLs.

Outcomes of Scleral Contact Lens Use in Veteran Population.

OBJECTIVES: To document outcomes associated with use of scleral contact lenses (SL) in the veteran population and analyze the medical and demographic factors that affect these outcomes, specifically those involved in contact lens discontinuation. METHODS: A retrospective study of consecutive patients first fitted with Jupiter Scleral lenses at the Michael E. DeBakey Veterans Affairs Medical Center between 2010 and 2018. The primary outcome was continuation of SL use at 1 year. Demographic factors and variables such as presence of comorbid diseases, improvement in visual acuity, and daily lens wear time were compared. Logistic regression analysis was used to determine which factors were associated with SL discontinuation. RESULTS: One hundred twenty patients with a mean age of 56.7±15.1 years were fitted with SL during the study period. The most common diagnosis was corneal ectasia (55.8%). Sixty-six (55.0%) patients had difficulty with wear, the most common being ocular irritation (20.0%) and mid-day fogging or bubbles (15.8%). Forty-one patients (34.2%) discontinued SL use with a median time from fitting to discontinuation of 5.2 months. The most common reason for SL discontinuation was difficulty with insertion and removal (53.7%). Comorbid neurologic disease had a statistically significant association with discontinuation (odds ratio 4.6, 95% confidence interval 1.3-17, P=0.022). There were statistically significant differences in mean visual acuity improvement (P=0.003) and daily wear time (P<0.001) but not age (P=0.70) between patients who continued and discontinued lens use. CONCLUSIONS: Scleral contact lenses are effective for treating a wide variety of ocular diseases and have positive outcomes in veterans. This study aids in understanding patient factors that affect outcomes of SL use in veterans. Further prospective studies are needed to make formal recommendations regarding candidate selection.

A 3-year Randomized Clinical Trial of MiSight Lenses for Myopia Control.

SIGNIFICANCE: Results of this randomized, double-masked clinical trial demonstrate the effectiveness of the MiSight soft contact lens in slowing myopia progression over multiple years. PURPOSE: The purpose of this study was to quantify the effectiveness of MiSight daily disposable soft contact lens in slowing the progression of juvenile-onset myopia. METHODS: Myopic children (spherical equivalent refraction, -0.75 to -4.00 D; astigmatism, <1.00 D) aged 8 to 12 years with no prior contact lens experience were enrolled in a 3-year, double-masked, randomized clinical trial at four investigational sites in four countries. Subjects in each group were matched for age, sex, and ethnicity and were randomized to either a MiSight 1-day contact lens (test) or Proclear 1-day (control; omafilcon A) and worn on a daily disposable basis. Primary outcome measures were the change in cycloplegic spherical equivalent refraction and axial length. RESULTS: Of the subjects enrolled, 75.5% (109/144) completed the clinical trial (53 test, 56 control). Unadjusted change in spherical equivalent refraction was -0.73 D (59%) less in the test group than in the control group (-0.51 ± 0.64 vs. -1.24 ± 0.61 D, P < .001). Mean change in axial length was 0.32 mm (52%) less in the test group than in the control group (0.30 ± 0.27 vs. 0.62 ± 0.30 mm, P < .001). Changes in spherical equivalent refraction and axial length were highly correlated (r = -0.90, P < .001). Over the course of the study, there were no cases of serious ocular adverse events reported. Four asymptomatic corneal infiltrative (one test, three control) events were observed at scheduled study visits. CONCLUSIONS: Results of this clinical trial demonstrate the effectiveness of the MiSight daily disposable soft contact lens in slowing change in spherical equivalent refraction and axial length.

Chimeric Antigen Receptor T-Cells (CAR T-Cells) for Cancer Immunotherapy - Moving Target for Industry?

The first CD19 CAR T-cell products, Kymriah and Yescarta, are entering the US market and also being evaluated for marketing authorization in the EU. This breakthrough has expanded the interest and also investments towards novel chimeric antigen receptor (CAR) designs, both for hematological malignancies and solid tumors. At the same time, there is active development in moving from autologous products to allogeneic, off-the-shelf -products. New manufacturing technologies are also emerging for production of these complex genetically-modified cells and even decentralized manufacturing in hospitals is under consideration. However, the high potency of CAR T-cells is associated with toxicity and not all patients respond to the treatment. In addition, the number of patient and product variables impacting the clinical outcome is high. The race towards novel CAR T treatment options for cancer patients has begun, but without careful design of the constructs and overall understanding of the factors that impact the ultimate outcome in each case, the road towards commercial success may be long and winding. This review discusses the product- and patient-related variables that may pose challenges for the industry and developers both from the scientific and regulatory perspective.

Ophthalmic Conditions Associated with Inpatient Falls among Veterans.

SIGNIFICANCE: Efforts to describe the relationship between pathological visual impairment and fall risk are typically confined to community dwellers. Among admitted patients, however, the associations are less understood. Fall risk assessment tools are used in some clinical settings, but most do not capture the suspected importance of ophthalmic pathologies in predicting the likelihood of an inpatient fall. PURPOSE: The purpose of this study was to determine the association between ophthalmic conditions and inpatient falls at the Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC), where vision and ophthalmic conditions are not considered when assessing fall risk. METHODS: This is a population-based, retrospective case-control study of 805 patients admitted to the MEDVAMC in January 2014 who had also visited the MEDVAMC Eye Clinic within 1 year of admission. The patients' eye examinations, ophthalmic diagnoses, and other indicators of constitutive health were compared between 60 patients who experienced an inpatient fall ("cases") and 749 patients who did not ("controls"). Significant differences between the cases and the controls were determined using logistic regression models. RESULTS: Baseline demographics were similar among the two groups. Ophthalmic conditions associated with an increased incidence of inpatient falls included age-related macular degeneration (odds ratio, 3.9; 95% confidence interval, 1.5 to 9.9; P = .008) and a presenting visual acuity of worse than 20/40 in the better-seeing eye (odds ratio, 2.0; 95% confidence interval, 1.0 to 4.1; P = .04). Those without falls demonstrated a better mean presenting visual acuity in the better-seeing eye compared with those who fell (logMAR, 0.12 ± 0.23 vs. 0.28 ± 0.49, P < .001). CONCLUSIONS: In this population, age-related macular degeneration and poor presenting visual acuity in the better-seeing eye are associated with increased incidence of inpatient falls. An assessment of visual function and ophthalmic diagnoses may be warranted upon admission to the hospital for increased prevention of inpatient falls.

Ethambutol optic neuropathy.

PURPOSE OF REVIEW: We provide a summary of the epidemiology, clinical findings, management and outcomes of ethambutol-induced optic neuropathy (EON). Ethambutol-induced optic neuropathy is a well-known, potentially irreversible, blinding but largely preventable disease. Clinicians should be aware of the importance of patient and physician education as well as timely and appropriate screening. RECENT FINDINGS: Two of the largest epidemiologic studies investigating EON to date showed the prevalence of EON in all patients taking ethambutol to be between 0.7 and 1.29%, a value consistent with previous reports of patients taking the doses recommended by the World Health Organization (WHO). Several studies evaluated the utility of optical coherence tomography (OCT) in screening for EON. These showed decreased retinal nerve fiber layer (RNFL) thickness in patients with clinically significant EON, but mixed results in their ability to detect such changes in patients taking ethambutol without visual symptoms. SUMMARY: Ethambutol-induced optic neuropathy is a well-known and devastating complication of ethambutol therapy. It may occur in approximately 1% of patients taking ethambutol at the WHO recommended doses, though the risk increases substantially with increased dose. All patients on ethambutol should receive regular screening by an ophthalmologist including formal visual field testing. Visual evoked potentials and OCT may be helpful for EON screening, but more research is needed to clarify their clinical usefulness. Patients who develop signs or symptoms of EON should be referred to the ethambutol-prescribing physician immediately for discontinuation or a reduction in ethambutol dosing.

Congenital toxoplasmosis: continued parasite proliferation in the fetal brain despite maternal immunological control in other tissues.

BACKGROUND: Congenital toxoplasmosis is a serious condition but little is known of the natural history of parasite development and associated fetal tissue destruction. METHODS: Two cases identified by ultrasound underwent induced abortion at 21 and 30 weeks' gestation. At autopsy, the placenta and fetal organs were examined by histology and immunocytochemistry employing anti-Toxoplasma stage-specific antibodies to confirm diagnosis and also provide information on the stage of parasite development. RESULTS: In both cases, maternal serology prior to termination showed both specific immunoglobulin M (IgM) and immunoglobulin G (IgG), whereas retrospective analysis of an earlier sample (12-14 weeks' gestation) showed only IgM reactivity consistent with infection occurring in the first trimester. The finding of a number of tissue cysts but few or no tachyzoites within the placenta and fetal adrenal and heart is characteristic of a chronic infection. However, in contrast, there were still areas of the fetal brain with large numbers of actively dividing, tissue-destructive tachyzoites. CONCLUSIONS: These observations show that continued parasite proliferation and tissue destruction can occur within the fetal brain even when there is a marked maternal immune response including maternal IgG. This finding strongly suggests that there may be benefits from treating cases of recently acquired congenital infection to destroy any remaining proliferating parasites located in immunologically protected sites such as the fetal brain.

Six years of wearer experience in children participating in a myopia control study of MiSight® 1 day.

PURPOSE: To evaluate the experience of children wearing soft contact lenses (CLs) during a trial of MiSight® 1 day (omafilcon A, CooperVision, Inc.), a dual-focus myopia-control daily disposable CL. METHODS: A 3-year, double-masked, randomised trial (Part 1) comparing experiences with MiSight 1 day and a single-vision control (Proclear® 1 day, omafilcon A, CooperVision, Inc.) of neophyte, myopic children (ages 8-12). Treatment (n = 65) and control (n = 70) participants received lenses at sites in Canada, Portugal, Singapore, and the UK. Successful participants completing Part 1 were invited to continue for a further 3 years wearing the dual-focus CL (Part 2), and 85 participants completed the 6-year study. Children and parent questionnaires were conducted at baseline, 1 week, 1 month, and every 6 months until the 60-month visit, with children only also completing questionnaires at 66 and 72 months. RESULTS: Throughout the study, children reported high satisfaction with handling (≥89% top 2 box [T2B]), comfort (≥94% T2B), vision (≥93% T2B for various activities), and overall satisfaction (≥97% T2B). Ratings for comfort and vision were not significantly different between lens groups, visits, or study parts and did not change when children switched to dual-focus CLs. Ratings for 'really easy' or 'kind of easy' application improved from the outset for the neophytes (57% at 1-week follow-up and 85% at 1-month follow-up) and remained high throughout the study (visit: P = 0.007; part: P = 0.0004). Overall satisfaction improved in Part 2 (P = 0.04). Wearing times increased in Part 2 (14 vs. 13 hrs/weekday; 13 vs. 12 hrs/day on weekends; P < 0.001); there were no differences between groups. CONCLUSIONS: Children adapted rapidly to full-time wear, rated lenses highly, and rarely reported issues. The dual-focus optics included in the MiSight® 1 day lenses successfully achieved myopia control without lowering subjective ratings when fitted to neophytes or children refitted from single-vision CLs.

Pharmacokinetic and pharmacodynamic similarity of biosimilar natalizumab (PB006) to its reference medicine: a randomized controlled trial.

BACKGROUND: PB006 (Polpharma Biologics S.A; marketed as Tyruko®, Sandoz) is an approved biosimilar to natalizumab (Tysabri®; Biogen [ref-NTZ]). This multicenter, double-blind, randomized, single-dose study was conducted to demonstrate pharmacokinetic/pharmacodynamic (PK/PD) similarity between PB006 and ref-NTZ. RESEARCH DESIGN AND METHODS: Healthy participants (N = 453) were randomized to receive 3 mg/kg infusion of PB006, US-licensed, or EU-approved ref-NTZ before an 85-day follow-up. Primary PK endpoint was total natalizumab serum concentration over time; secondary PK endpoints explored concentration changes. Primary PD endpoints compared CD19+ cell counts and percentage α4-integrin receptor saturation, per natalizumab's mechanism of action. Secondary PD endpoints explored serum changes in sVCAM-1 and sMAdCAM-1, CD34+, and CD19+ cells. Safety, tolerability, and immunogenicity were assessed. RESULTS: The primary PK endpoint was met, with 90% confidence intervals (CIs) of the geometric mean for serum test/reference ratios contained within a prespecified margin (0.8-1.25). All primary PD endpoints were met, with 90% and 95% CIs within this similarity margin for baseline-adjusted CD19+ cell counts and percentage α4-integrin receptor saturation. All secondary endpoints were similarly contained, except sVCAM. No notable differences in safety, tolerability, or immunogenicity were observed. CONCLUSION: Similarity was confirmed, with PB006 demonstrating PK/PD behavior consistent with that of ref-NTZ. CLINICAL TRIAL REGISTRATION: EudraCT number 2019-003874-15.

PB006 (developed by Polpharma Biologics S.A; and marketed as Tyruko® by Sandoz) is an approved biosimilar to the reference medicine, natalizumab (Tysabri®, Biogen [ref-NTZ]) used to treat relapsing forms of multiple sclerosis. Approved biosimilar medicines have been shown to be as safe and effective as their reference medicines via different types of comparisons to the reference medicine, confirming that physicians and patients can expect the same clinical outcome.This study was conducted to confirm that PB006 acts the same way in the body as ref-NTZ. Healthy participants received one dose of either PB006, ref-NTZ from the US or ref-NTZ from Europe. During the study, blood samples were tested to confirm how much of each medicine was present in participants' blood, as well as to assess changes in immune cells or proteins related to how natalizumab works. The study also measured whether any treatment caused unwanted side effects or caused any changes in the immune system that may stop the medicine working.The results showed that PB006 behaved in the same way as ref-NTZ in the blood. All reported side effects were similar between groups and were as expected for this medicine, and neither PB006 nor ref-NTZ caused any important or unexpected changes to the immune system. This study showed that biosimilar natalizumab, PB006, behaves in the same way as ref-NTZ, and the same treatment outcomes can be expected.

IMI-Onset and Progression of Myopia in Young Adults.

Myopia typically starts and progresses during childhood, but onset and progression can occur during adulthood. The goals of this review are to summarize published data on myopia onset and progression in young adults, aged 18 to 40 years, to characterize myopia in this age group, to assess what is currently known, and to highlight the gaps in the current understanding. Specifically, the peer-reviewed literature was reviewed to: characterize the timeline and age of stabilization of juvenile-onset myopia; estimate the frequency of adult-onset myopia; evaluate the rate of myopia progression in adults, regardless of age of onset, both during the college years and later; describe the rate of axial elongation in myopic adults; identify risk factors for adult onset and progression; report myopia progression and axial elongation in adults who have undergone refractive surgery; and discuss myopia management and research study design. Adult-onset myopia is common, representing a third or more of all myopia in western populations, but less in East Asia, where onset during childhood is high. Clinically meaningful myopia progression continues in early adulthood and may average 1.00 diopters (D) between 20 and 30 years. Higher levels of myopia are associated with greater absolute risk of myopia-related ocular disease and visual impairment, and thus myopia in this age group requires ongoing management. Modalities established for myopia control in children would be options for adults, but it is difficult to predict their efficacy. The feasibility of studies of myopia control in adults is limited by the long duration required.

Fluctuation in visual acuity during soft toric contact lens wear.

PURPOSE: To quantify changes in visual acuity (VA) with soft toric contact lenses as a result of lens movement and/or rotational instability caused by versional eye movements. METHODS: A novel chart for vision assessment at near (40 cm) for soft toric contact lenses (VANT chart),consisting of a central, color-coded logMAR panel and eight peripheral letter targets set on a white background measuring 60 × 40 cm was constructed. In the developmental phase of the work, 10 subjects (20 eyes) wore 2 toric lenses in random order, and the impact of rapid and delayed eye versions in 8 directions of gaze on VANT acuity was investigated. In phase 2, 35 subjects (68 eyes) wore 4 toric lenses in random order, and a streamlined clinical protocol using the VANT chart was implemented. Standard assessments of toric lens fit and distance VA were also performed. RESULTS: Testing in the first phase showed no difference for change in VA for rapid vs. delayed version movements, (p = 0.17) but acuity reduction was greater for diagonal compared with horizontal/vertical versions (p = 0.06). As such, testing in phase 2 proceeded using rapid, diagonal versions only. In this second phase, there were differences for low-contrast distance VA measures between lens types (p = 0.02) and for both VANT baseline acuity (p = 0.03) and postversion acuity (p = 0.04), but no differences were found between lenses for magnitude of vision loss (p = 0.91), which was about one line. No relationship was established between the magnitude of vision loss and measured rotational stability (p = 0.75). CONCLUSIONS: This work has demonstrated that conventional approaches to measuring VA do not fully replicate the "real world" experience of soft toric lens wearers. The VANT chart has shown that VA is reduced immediately after versional eye movements and suggests that more dynamic methods of assessing visual performance should be considered for soft toric contact lens wearers, especially given the apparent inability of lens stability measurements to predict visual performance.

Ocular health of children wearing daily disposable contact lenses over a 6-year period.

PURPOSE: To report on the ocular health and safety of children fit with soft hydrogel daily-disposable contact lenses, and followed for 6-years in a double-masked clinical trial investigating the performance of a dual-focus contact lens designed to control myopia progression. METHODS: Children aged 8-12 years, naïve to contact lens wear, were enrolled across four international sites. During years 1-3, children were randomised to either MiSight® 1 day or Proclear® 1 day (both omafilcon A, CooperVision, Inc.). The lenses were identical in material and geometry except for the front optical zone design. At the end of year-3, all those wearing Proclear 1 day were switched to MiSight 1 day, therefore all wore MiSight 1 day in years 4-6. Subjects agreed to wear the lenses at least 10-hours/day, 6-days/week. After dispensing, study visits were at 1-week, 1-month, 6-months and every 6-months until 6-years. At each visit, ocular measurements and subjective responses were recorded. Biomicroscopy used 0-4 grading scales; grade 0 represented no findings. RESULTS: 144 children were enrolled: 69F:75M; mean age 10.1 years; mean cycloplegic spherical-equivalent refraction -2.11D; ethnicities included 34 East-Asian, 12 West-Asian, and 79 Caucasian. 92 completed the 6-years. Only three subjects discontinued due to an ocular adverse event (AE). No contact lens related AEs were classified as serious. The incidence rate of infiltrative AEs was 0.61% (6.1/1000 wearing-years; 95%CI: 0.24%-1.57%). The most common biomicroscopy findings were limbal, bulbar and tarsal hyperaemia and tarsal roughness. 99% of all biomicroscopy findings were grade-1 or lower. After 6-years of lens wear, ocular health by biomicroscopy was similar to pre-lens wear. CONCLUSIONS: Across the 6-years, there were no contact lens related serious AEs and biomicroscopy showed no significant changes. Results suggest that children this age can successfully wear daily-disposable hydrogel contact lenses with minimal impact on ocular physiology.