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.

Global trends in myopia management attitudes and strategies in clinical practice - 2019 Update.

PURPOSE: A survey in 2015 identified a high level of eye care practitioner concern about myopia with a reported moderately high level of activity, but the vast majority still prescribed single vision interventions to young myopes. This research aimed to update these findings 4 years later. METHODS: A self-administrated, internet-based questionnaire was distributed in eight languages, through professional bodies to eye care practitioners globally. The questions examined: awareness of increasing myopia prevalence, perceived efficacy of available strategies and adoption levels of such strategies, and reasons for not adopting specific strategies. RESULTS: Of the 1336 respondents, concern was highest (9.0 ±â€¯1.6; p < 0.001) in Asia and lowest (7.6 ±â€¯2.2; p < 0.001) in Australasia. Practitioners from Asia also considered their clinical practice of myopia control to be the most active (7.7 ±â€¯2.3; p < 0.001), the North American practitioners being the least active (6.3 ±â€¯2.9; p < 0.001). Orthokeratology was perceived to be the most effective method of myopia control, followed by pharmaceutical approaches and approved myopia control soft contact lenses (p < 0.001). Although significant intra-regional differences existed, overall, most practitioners did not consider single-vision distance under-correction to be an effective strategy for attenuating myopia progression (79.6 %), but prescribed single vision spectacles or contact lenses as the primary mode of correction for myopic patients (63.6 ±â€¯21.8 %). The main justifications for their reluctance to prescribe alternatives to single vision refractive corrections were increased cost (20.6 %) and inadequate information (17.6 %). CONCLUSIONS: While practitioner concern about myopia and the reported level of activity have increased over the last 4 years, the vast majority of eye care clinicians still prescribe single vision interventions to young myopes. With recent global consensus evidence-based guidelines having been published, it is hoped that this will inform the practice of myopia management in future.

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.

Light distortion and spherical aberration for the accommodating and nonaccommodating eye.

To evaluate how different amounts of induced spherical aberration (SA) affect the light distortion (LD) phenomena, tests were performed using an experimental device to measure the distortion (haloes, glare, and so on) of a point source. To simulate the effect of SA, eight different phase plates between +0.300 and −0.300 µm of SA for a 5-mm aperture were used in a random and double-masked experimental design. Measurements were performed at a distance of 2 m in a darkened room in 10 eyes of five subjects with a mean age of 26.4±6.1 years and a mean refractive error of −0.50±0.70 D. Data were obtained with natural pupil and after pupil dilatation. The measurements with this experimental system showed a significant increase in all distortion parameters with cycloplegia for the phase plates with the higher positive SA (+0.300 and +0.150 µm). The disturbance index increased from 14.86±6.12% to 57.98±36.20% (p<0.05) with the +0.300 µm plate. The same effect was observed through at a much lower rate when the eye could accommodate. Plates inducing negative SA did not change the LD compared to the control condition without induction of SA or even decreased the effect of distortion. Pupillary dilation and cyclopegia led to a significant increase in the size of the LD when increasing values of SA were induced. Accommodation and pupillary constriction are capable of compensating the degradation of the optical quality induced.

Stabilization in early adult-onset myopia with corneal refractive therapy.

PURPOSE: To describe the stabilization of early adult-onset myopia in three university students after initiating orthokeratology treatment with corneal refractive therapy contact lenses. METHODS: Three Caucasian early adult-onset progressing myopic subjects (1 male, 2 females) were fitted with corneal refractive therapy lenses to correct myopia between -1.50 and -2.50 D of sphere using Paragon CRT (Paragon Vision Sciences, Mesa, AZ) lenses for overnight orthokeratology. The pre-treatment refractive history from 2005 as well as refraction and axial length after treatment onset are reported over a period of 3 years between December 2009 and January 2013 with an additional year of follow-up after treatment discontinuation (January-December 2013). The peripheral refractive patterns and topographic changes are also reported individually. RESULTS: Treatment was successful in all three subjects achieving uncorrected visual acuity of 20/20 or better monocularly. During a period of 3 years of follow-up the subjects did not experience progression in their refractive error, nor in their axial length (measured during the last 2 years of treatment and 1 year after discontinuation). Furthermore, the subjects recovered to their baseline refraction and did not progressed further over the following year after lens wear discontinuation. CONCLUSIONS: We cannot attribute a causative effect to the orthokeratology treatment alone as underlying mechanism for myopia stabilization in this 3 patients. However, the present report points to the possibility of stabilization of early adult-onset myopia progression in young adults using corneal refractive therapy treatment.

Symptoms and Signs in Rigid Gas Permeable Lens Wearers During Adaptation Period.

OBJECTIVES: To evaluate neophyte contact lens wearers' fitting to rigid gas permeable (RGP) contact lenses in terms of wearing time, tear volume, stability, corneal staining, and subjective ratings, over a 1-month period of time. METHODS: Twenty-two young healthy subjects were enrolled for wearing RGP on a daily wear basis. The participants included in this study never wore contact lenses and showed a value under 10 in McMonnies Questionnaire. Contact Lens Dry Eye Questionnaire, Visual Analog Scales, Schirmer test, tear film break-up time (BUT), and corneal staining grading were performed. Follow-up visits were scheduled at 1, 7, 15, and 28 days. RESULTS: Six subjects dropped out due to discomfort from the study before 1 month (27% of discontinuation rate). Successful RGP wearers (16 participants) achieved high levels of subjective vision and reported comfort scores of approximately 9 of 10 between 10 and 15 days. They reported wearing their lenses for an average of 10.12±2.43 hr after 1 month of wear. Conversely, unsuccessful wearers discontinued wearing the lenses after the first 10 to 15 days, showing comfort scores and wearing time significantly lower compared with the first day of wear. Schirmer test showed a significant increase at 10 days (P<0.001), and the BUT trends decreased after the first week of wear in unsuccessful group. CONCLUSIONS: Symptomatology related with dryness and discomfort, detected during the first 10 days of the adaptation, may help the clinician to predict those participants who will potentially fail to adapt to RGP lens wear.

Strategies to Regulate Myopia Progression With Contact Lenses: A Review.

PURPOSE: Higher myopic refractive errors are associated with serious ocular complications that can put visual function at risk. There is respective interest in slowing and if possible stopping myopia progression before it reaches a level associated with increased risk of secondary pathology. The purpose of this report was to review our understanding of the rationale(s) and success of contact lenses (CLs) used to reduce myopia progression. METHODS: A review commenced by searching the PubMed database. The inclusion criteria stipulated publications of clinical trials evaluating the efficacy of CLs in regulating myopia progression based on the primary endpoint of changes in axial length measurements and published in peer-reviewed journals. Other publications from conference proceedings or patents were exceptionally considered when no peer-review articles were available. RESULTS: The mechanisms that presently support myopia regulation with CLs are based on the change of relative peripheral defocus and changing the foveal image quality signal to potentially interfere with the accommodative system. Ten clinical trials addressing myopia regulation with CLs were reviewed, including corneal refractive therapy (orthokeratology), peripheral gradient lenses, and bifocal (dual-focus) and multifocal lenses. CONCLUSIONS: CLs were reported to be well accepted, consistent, and safe methods to address myopia regulation in children. Corneal refractive therapy (orthokeratology) is so far the method with the largest demonstrated efficacy in myopia regulation across different ethnic groups. However, factors such as patient convenience, the degree of initial myopia, and non-CL treatments may also be considered. The combination of different strategies (i.e., central defocus, peripheral defocus, spectral filters, pharmaceutical delivery, and active lens-borne illumination) in a single device will present further testable hypotheses exploring how different mechanisms can reinforce or compete with each other to improve or reduce myopia regulation with CLs.

Performance of three multipurpose disinfecting solutions with a silicone hydrogel contact lens.

PURPOSE: To evaluate the clinical performance of a silicone hydrogel (Si-Hy) soft contact lens (CL) in combination with three different multipurpose disinfecting solutions (MPDSs). METHODS: This was a prospective, randomized, single-masked, crossover, and comparative study in which 31 habitual soft CL wearers were randomly assigned to one of the three MPDSs (Synergi, COMPLETE RevitaLens, and OPTI-FREE PureMoist) for 1 month with a 1-week wash-out period between each exposure. All subjects were successfully refitted with a Si-Hy CL (Biofinity). Subjects were then scheduled for follow-up visits after 1 month of lens wear, being evaluated at 2 and 8 hours after lens insertion. Visual Analogue Scales (VAS) were used to gauge comfort rating. RESULTS: The tarsal conjunctiva showed a significantly different degree of lid redness between the MPDSs at the 2-hour visit (P < 0.05, Kruskal-Wallis test), being lower for COMPLETE RevitaLens compared to the other two MPDSs (Mann-Whitney U test). Furthermore, a significantly different degree of lid roughness at the 8-hour visit was seen (P < 0.05, Kruskal-Wallis test), being higher for Synergi (Mann-Whitney U test). The subjective comfort was similar with the three MPDSs. CONCLUSION: Tarsal conjunctival response should be also considered in the context of the clinical performance of MPDs at the ocular surface.

Oxygen diffusion and edema with modern scleral rigid gas permeable contact lenses.

PURPOSE: We defined the theoretical oxygen tension behind modern scleral contact lenses (CLs) made of different rigid gas permeable (RGP) materials, assuming different thickness of the tear layer behind the lens. A second goal was to show clinically the effect of the postlens tear film on corneal swelling. METHODS: We simulated the partial pressure of oxygen across the cornea behind scleral CLs made of different lens materials (oxygen permeability Dk, 75-200 barrer) and different thickness (Tav, 100-300 µm). Postlens tear film thicknesses (Tpost-tear) ranging from 150 to 350 µm were considered. Eight healthy subjects were fitted randomly with a scleral lens with a thin and a thick postlens tear layer in two different sessions for a period of 3 hours under open-eye conditions. RESULTS: The CLs with less than 125 barrer of Dk and a thickness over 200 µm depleted the oxygen availability at the lens-cornea interface below 55 mm Hg for a postlens tear film of 150 µm. For a postlens tear film thickness of 350 µm, no combination of material or lens thickness will meet the criteria of 55 mm Hg. Our clinical measures of corneal edema showed that this was significantly higher (P < 0.001, Wilcoxon signed ranks test) with the thicker compared to the thinner Tpost-tear (mean ± SD, 1.66 ± 1.12 vs. 4.27 ± 1.19%). CONCLUSIONS: Scleral RGP CLs must be comprised of at least 125 barrer of oxygen permeability and up to 200 µm thick to avoid hypoxic effects even under open eye conditions. Postlens tear film layer should be below 150 µm to avoid clinically significant edema.

Shedding light on night myopia.

First described during the 18th century, the cause of night myopia remains a controversial topic. Whereas several explanations have been suggested in the literature, particularly related with accommodation or chromatic shift in scotopic light conditions, no definitive explanation for its aetiology has been provided. We describe an experiment in which ocular refractive state was objectively and subjectively measured while viewing two kind of stimulus: letters on a bright background and a punctual source of light in a dark background. We found that under photopic conditions the optimum refractive state of the accommodating eye is significantly more myopic when maximizing perceived quality of a point source on a dark background compared to a conventional letter chart with black letters on a white background. Optical modeling suggested this difference in refractive state is due to spherical aberration. Since isolated point sources are more likely encountered at night, whereas extended objects are more likely encountered in the daytime, our results suggest that a significant part of the night myopia phenomenon is determined by the nature of the visual stimulus and the visual task used to assess ocular refractive state.

"In situ" corneal and contact lens thickness changes with high-resolution optical coherence tomography.

PURPOSE: To show the use of high-resolution spectral-domain optical coherence tomography (HR-SOCT) for the in situ evaluation of epithelial, stromal, and contact lens (CL) thickness changes under closed-eye conditions without lens removal. METHODS: Eight young healthy patients wore a thick soft CL for 90 minutes under closed-eye conditions, and measures of epithelial and stromal corneal thickness were obtained at regular intervals using a HR-SOCT (Copernicus HR; Optopol Tech. SA, Zawiercie, Poland). RESULTS: Minimal changes in epithelial thickness were detected with a transient statistically significant increase in epithelial thickness in the fellow control eye 30 minutes after insertion (P = 0.028). A significant and progressive increase in stromal thickness up to 8% after 90 minutes of lens wear was observed at a constant rate of 2.5% every 30 minutes, being statistically significant in all observations (P < 0.001). Fellow control eyes also showed a significant increase in stromal thickness at a much lower rate of 0.5% every 30 minutes. Lens thickness decreased significantly by 2% after 90 minutes of lens wear under closed-eye conditions (P < 0.001). Individual analysis showed that all eyes displayed stromal swelling, whereas only half of them showed epithelial swelling. CONCLUSIONS: Increase in stromal thickness and a slight decrease in lens thickness were observed in response to a hypoxic stimulus under closed-eye conditions. HR-SOCT is a powerful tool to investigate in vivo the physiological interactions between cornea and CLs.

Two single descriptors of endothelial polymegethism and pleomorphism.

PURPOSE: To compute two new quantitative parameters that directly reflect the level of polymegethism and pleomorphism using data provided by a non-contact specular microscope. METHODS: We examined right eyes of 306 voluntaries (102 males, 204 females) whose ages ranged from 6 to 82 years (mean +/- SD, 44 +/- 22 years). Endothelial cell density (ECD), average cell size (ACS), standard error of cells surface (SEM), coefficient of variation in cell size (CV) and hexagonality index (HI) were obtained. In addition, two new indices of polymegethism (POLi) and pleomorphism (PLEi) were derived using weighted linear combinations of data obtained from instrument classification of endothelial cells based on the individual counts of cells by size and number of sides respectively, as provided by the instrument. Values of POLi and PLEi were compared between a group of diabetic patients and a group of age-matched controls. RESULTS: Average values of POLi and PLEi were 10.47 +/- 3.94 and 8.36 +/- 1.21 respectively. POLi and PLEi display high correlation with SEM (r = 0.911, r = 0.664), ECD (r = -0.997, r = -0.585), ACS (r = 0.997, r = 0.441), ACS (SD) (r = 0.883, r = 0.682), CV (r = 0.301, r = 0.712) and HI (r = -0.437, r = -0.991); all these correlations were highly significant (p < 0.001). POLi and PLEi also showed significant positive correlations with age (r = 0.765, p < 0.001 and r = 0.428, p < 0.001 respectively). POLi was significantly higher in a group of diabetic patients when compared with another group of age-matched controls (p = 0.001). CONCLUSIONS: Two single quantitative parameters of endothelial polymegethism and pleomorphism (POLi and PLEi respectively) have been derived from the data obtained with a commercial non-contact specular microscope. These parameters have been demonstrated to identify differences between the corneal endothelium of diabetic and non-diabetic patients.

Pupil size, white-to-white corneal diameter, and anterior chamber depth in patients with myopia.

PURPOSE: To evaluate anatomical parameters in a population of patients with myopia. METHODS: Nine hundred sixty-four myopic eyes (-3.00 to -20.00 diopters [D] spherical equivalent refraction) were evaluated to measure mesopic and photopic pupil size with an infrared pupillometer; anterior chamber depth and white-to-white corneal diameter were obtained with Orbscan II (Bausch & Lomb). Correlation analysis was performed to evaluate the relationships among anatomical parameters of the anterior segment of the eye. RESULTS: Average change in pupil size between mesopic and photopic conditions shows a uniform gap of 1.5 mm in patients aged 18 to 62 years with a slight insignificant trend to decrease with age. Photopic and mesopic pupil size were highly correlated (r=0.694, P<.001) and the difference between both measures was positively correlated with mesopic pupil size (r=0.207, P<.001) and inversely correlated with photopic pupil size (r=0.561, P<.001). Anterior chamber depth and white-to-white corneal diameter were positively correlated (r=0.389, P<.001). White-to-white corneal diameter and anterior chamber depth were not correlated with age (r=-0.096, P<.001) or anterior chamber depth (r=-0.183, P<.001-0.183) as a function of age. CONCLUSIONS: Average difference between photopic and mesopic pupil size remained constant across the range of ages included in this cohort. A positive correlation was noted between anterior segment dimensions, and anterior chamber depth decreased with age.

Prevalence of corneal astigmatism before cataract surgery.

PURPOSE: To analyze the prevalence and presentation patterns of corneal astigmatism in cataract surgery candidates. SETTING: University of Valencia, Valencia, Spain. METHODS: Refractive and keratometric values were measured before surgery in patients having cataract extraction. Descriptive statistics of refractive and keratometric cylinder data were analyzed and correlated by age ranges. RESULTS: Refractive and keratometric data from 4,540 eyes of 2,415 patients (mean age 60.59 years +/- 9.87 [SD]; range 32 to 87 years) differed significantly when the patients were divided into 10-year subsets. There was a trend toward less negative corneal astigmatism values, except the steepest corneal radius and the J(45) vector component, in older groups (Kruskal-Wallis, P<.01). In 13.2% of eyes, no corneal astigmatism was present; in 64.4%, corneal astigmatism was between 0.25 and 1.25 diopters (D) and in 22.2%, it was 1.50 D or higher. CONCLUSIONS: Corneal astigmatism less than 1.25 D was present in most cataract surgery candidates; it was higher in about 22%, with slight differences between the various age ranges. This information is useful for intraocular lens (IOL) manufacturers to evaluate which age ranges concentrate the parameters most frequently needed in sphere and cylinder powers and for surgeons to evaluate which IOLs provide the most effective power range.