Multifocal Soft Contact Research Articles

Multifocal Soft Contact Lenses for the Treatment of Myopia Progression in Children: A Report by the American Academy of Ophthalmology

To review the published literature assessing the efficacy of multifocal soft contact lenses for the treatment of myopia progression in children 18 years of age and younger. A literature search of the PubMed database was conducted last in March 2024 and was limited to articles published in English without date restrictions. The search yielded 76 articles, which were reviewed by the primary author in abstract form, and 28 articles were selected for full-text review. Twelve articles were deemed to have met the inclusion criteria and were assigned a level of evidence rating by the panel methodologist. Eleven studies were rated level I and 1 study was rated level II. All studies showed less myopic progression, with changes in spherical equivalent (SE) ranging from 0.22 to 0.81 diopters (D) for multifocal soft contact lenses compared with 0.50 to 1.45 D in control groups who used single-vision spectacles or single-vision contact lenses over the course of at least 1 year. Additionally, axial elongation was less in the multifocal soft contact lens group compared with control groups, with a change in axial length (AL) of 0.05 to 0.39 mm in treatment groups compared with 0.17 to 0.67 mm in control groups with at least 1 year of follow-up. The difference in change between the groups was clinically modest and statistically significant in 11 studies for SE and in all 12 studies for AL. No serious adverse events were reported in any of the studies. Level 1 evidence supports slower myopia progression and AL elongation in children who used multifocal soft contact lenses compared with spectacles or single-vision contact lenses over at least 1 year of follow-up. However, few data are available on optimal treatment duration, the progression over longer periods, or progression after discontinuation of the multifocal contact lenses. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Multifocal Rigid Gas Permeable Contact Lenses with Multi-Tangential Positioning and Corrected Spherical Aberration for Myopia Control

Slowing the progression of myopia has become an extensive concern for parents of children with myopia. According to research findings in animals, eye growth is primarily influenced by the peripheral retina. Treatment options such as orthokeratology, daytime bifocal or multifocal soft contact lens usage are available because they can induce relative myopia in the periphery. In this work, a new multifocal rigid gas permeable (MFRGP) contact lens for myopia prevention and control in adolescents was designed specifically for preventing and controlling myopia in adolescents. This lens features a multi-tangent alignment curve, smaller spherical aberration, and transition defocus. FocalPoints and UPC 100 Vision were used for lens design and lathing, respectively. The lens structure and power profile were measured using IS830 and CONTEST 2, respectively. The elimination of lens aberrations was achieved through design optimization using ZEMAX with ray tracing. Lens fitting was evaluated using slit-lamp microscopy and corneal topography.

Multifocal Optics for Myopia Control.

The rising prevalence of myopia among children and adolescents necessitates effective interventions to mitigate long-term risks, such as retinal detachment and macular degeneration. Traditional approaches like undercorrection with single-vision lenses have proven ineffective. Recent research underscores the significance of peripheral vision in managing myopia progression. While hyperopic defocus in the peripheral retina may encourage axial elongation, multifocal lenses designed to induce peripheral myopic defocus can potentially curb this elongation. Randomized controlled trials (RCTs) have demonstrated that spectacle lenses with peripheral modifications, such as highly aspherical lenslets (HAL) or defocus incorporated multiple segments (DIMS), reduce myopia progression and axial elongation over 2 years. Similarly, multifocal contact lenses, especially those with high-add power (+ 2.50 D), have shown comparable reductions over 3 years. Safety is a critical consideration in myopia control. Multifocal spectacle lenses with peripheral plus designs are generally well tolerated, with only transient side effects, like dizziness and blurred vision. Soft multifocal contact lenses also exhibit a favorable safety profile, with low rates of serious adverse events. Thorough monitoring and reporting in these studies are essential to provide assurance about the safety of these interventions for children. Future research should aim to include more diverse populations in order to ensure the generalizability of findings across various demographic groups. Additionally, real-world data would offer valuable insights into the performance of these treatments in everyday scenarios. Observational studies, less influenced by industry sponsorship, could further validate these findings. Lastly, the clinical significance of the observed effects should be critically assessed to confirm that the reported benefits lead to meaningful reductions in myopia progression.

Multifocal contact lenses. Easy fitting algorithm and new possibilities in presbyopia correction with TOTAL30 Multifocal

Multifocal soft contact lenses are the fastest growth segment in contact lenses. While presbyopic patients demonstrate an increasing interest in contact lenses, not all practitioners actively integrate multifocal lenses into their practices. Some of the reasons include the perception that multifocal fitting is time-consuming and chances of successful adaptation of “ageing” patients are low. The purpose of this publication is to provide an overview of the latest multifocal contact lens, essential fitting steps and instruments for quick and effective multifocal lens fitting.

Refractive power profiles of commercially available soft multifocal contact lenses for myopia control.

Lens power profiles can provide valuable insights on the imposed optical defocus and visual experience of contact lens wearers, especially in the context of myopia control. This study measured the refractive power profiles of multifocal soft contact lenses (MFCLs) currently used or that have the potential for use in myopia control using high spatial resolution aberrometry. The instrument's repeatability for determining MFCLs power profiles was also assessed. The power profiles of 10 MFCLs of various designs (centre-distance, centre-near and extended depth of focus) were measured using the Lambda-X NIMOEVO, a phase shifting Schlieren-based device. Power profiles were graphically expressed as measured power at each chord position and the maximum add power was calculated. The repeatability of the NIMOEVO was expressed as the within-subject standard deviation at each chord position for a subset of five MFCLs. The measured distance powers differed from nominal powers for more than half of the MFCLs with a definable distance zone. There were variations in the chord position of the distance and near correction zones, rate of power transitions and calculated maximum add between the MFCLs which did not depend on lens design. For half of the MFCLs, the power profile shape was inconsistent between different nominal back vertex powers of the same design. The repeatability of the NIMOEVO was dependent on the lens design, with designs featuring faster rates of power change exhibiting worse repeatability. Significant differences in MFCL power profiles were found which were not adequately represented in labelling. This is likely due to the small number of parameters used to define lens power characteristics. Eye health care practitioners should be aware of potential differences in power profiles between different MFCLs, which will impact the retinal defocus introduced during lens wear and the wearer's visual experience.

Subjective impressions with myopia control contact lenses versus single vision lenses: A systematic review and meta-analysis

PurposeTo gain insight into patients’ visual experiences and satisfaction when using different forms of myopia control lenses. MethodsPubMed, Cochrane Library, Embase, Scopus and Web of Science databases were searched for articles assessing subjective visual quality with myopia control lenses compared with single-vision lenses (SVLs) up to July 10, 2023. Eight-hundred-and-three articles were retrieved, reviewed and any questionnaire items on subjective impressions of lens wear were meta-analysed. Subgroup analyses were based on the magnitude of defocus (add power) of multifocal soft contact lenses (MFSCLs) and age groups. A random-effects model was employed for meta-analysis, and I2 statistic used to assess the statistical heterogeneity. ResultsNineteen articles fit the criteria, but only six articles involving MFSCLs had relevant data. MFSCLs were associated with lower subjective ratings of vision at different distances compared to SVLs (p < 0.001), but the differences were less than one unit. MFSCLs also yielded lower ratings when moving or walking and/or climbing stairs at −0.38 (−0.69 to −0.07, p = 0.02; I2 = 85 %, p < 0.001) and for subjective comfort (difference of −0.23, −0.41 to −0.05, p = 0.01; I2 = 63 %, p < 0.001). Subjective ratings for playing sports were not different between groups. Experience with MFSCLs was rated lower by young adults compared to children for all variables. In both children and young adults, ratings were lower with higher add compared to lower add MFSCLs. ConclusionAlthough subjective ratings for vision and comfort were lower with MFSCLs compared to SVLs, the difference was mostly less than one unit. Importantly, young adults rated their visual experience lower compared to children.

Clinical performance and fit success of lehfilcon A and lotrafilcon B daily wear monthly replacement multifocal soft contact lenses

Clinical performance and fit success of lehfilcon A and lotrafilcon B daily wear monthly replacement multifocal soft contact lenses

A survey on the use of fitting guides for soft multifocal contact lenses

A survey on the use of fitting guides for soft multifocal contact lenses

Effects of Optical Zone Variation of High-Addition Multifocal Contact Lenses on the Global Flash Multifocal Electroretinography.

To evaluate the retinal response to myopic defocus after the wear of soft multifocal contact lenses with high addition through electroretinography. Twenty-seven participants meeting inclusion criteria were enrolled. Tropicamide 1% drops (2) were instilled. Participants were then fitted with three different contact lenses: a single-vision spherical lens (SE +3.00 D), L1, serving as a control, and two soft multifocal lens designs (SE +3.00 D/add +10 D), one with a central distance zone of 4.0 mm (L2) and one with a central distance zone of 7.0 mm (L3). A global flash multifocal electroretinography was performed. Direct component (DC) amplitude, DC peak time, induced component (IC) amplitude, and IC peak time were recorded. Waveforms were grouped into five concentric areas, covering from 0° to 24° of retinal eccentricity. Differences of L2/L3 versus L1 were analyzed with t tests. Finally, correlations were calculated between the percentage of defocus in the pupil area versus the electroretinography results. Results show that the DC amplitude, caused mainly by photoreceptors and bipolar cells, is not influenced by the design of the lenses. The IC amplitude, however, is significantly decreased when the lens with a smaller optical zone (L2) is worn. This significant difference only concerns the ring 5, which corresponds to a retinal eccentricity of 15.7° to 24.0°. Soft multifocal lens designs influence the peripheral retinal reaction to defocus. A larger treatment zone seems to significantly impact the retinal response to defocus between 15.7° and 24.0° of eccentricity from the macula.

Simulation of daily soft multifocal contact lenses using SimVis Gekko: from in-vitro and computational characterization to clinical validation

Multifocal contact lenses (MCLs) are one of the solutions to correct presbyopia, but their adoption is not widespread. To address this situation, visual simulators can be used to refine the adaptation process. This study aims to obtain accurate simulations for a visual simulator (SimVis Gekko; 2EyesVision) of daily soft MCL designs from four manufacturers. In-vitro characterization of these MCLs—several powers and additions- was obtained using NIMO TR-1504. From the averaged relative power profiles across powers, phase maps were reconstructed and the Through-Focus Visual Strehl metric was calculated for each MCL design. The SimVis Gekko simulation corresponding to each MCL design was obtained computationally and bench-validated. Finally, the MCL simulations were clinically validated involving presbyopic patients. The clinical validation results show a good agreement between the SimVis Gekko simulations and the real MCLs for through-focus visual acuity (TF-VA) curves and VA at three real distances. All MCL designs showed a partial correlation higher than 0.90 and a Root Mean Square Error below 0.07 logMAR between the TF-VA of simulations and Real MCLs across subjects. The validity of the simulation approach using SimVis Gekko and in-vitro measurements was confirmed in this study, opening the possibility to accelerate the adaptation of MCLs.

Multifocal contact lens success predictability

PurposeThe current multi-study analysis combined data from three studies to quantify the relationship between the initial reaction to soft multifocal contact lens (MFCL) design types at dispensing and evaluate the predictability of overall vision satisfaction (OVS) and intention to purchase (ITP) after 1 week of wear. MethodThree prospective studies tested MFCLs over 1-week of wear following the same protocol, using a range of potentially predictive ratings at dispensing, and both OVS and ITP at 1-week as an indicator acceptance level. In each study, two of MyDay® multifocal, clariti® 1 day multifocal, Biofinity® multifocal (worn as a daily disposable lens) or 1 DAY ACUVUE® MOIST MULTIFOCAL were dispensed for 1-week of daily wear. OVS was recorded on a 100-point VAS and ITP on a 5-point LIKERT scale. Fourteen possible predictors were entered in the statistical model, and predictability was assessed using Chi-square Automatic Interaction Detector (CHAID) statistical test. ResultsA total of 210 participants (152 female & 58 male; 53.9 ± 6.5 years, range 41–71 years), representing 420 MFCL fits, equally distributed between emergent n = 65, established n = 70 and advanced n = 75 presbyopes, completed the studies. OVS on dispensing was the predictor of both OVS (p < 0.001) and ITP (p < 0.001) at 1-week. For OVS predictability, 70.8 % with OVS at dispensing > 91 points reported good OVS at 1-week and 73.4 % with OVS on dispensing ≤ 80 points reported poor OVS at 1-week. For ITP predictability, 74.6 % with OVS at dispensing > 94 points reported a positive ITP at 1-week and 65.9 % with OVS on dispensing ≤ 63 points reported negative ITP at 1-week. ConclusionOverall vision satisfaction at the time of dispensing MFCLs is a powerful indicator of both OVS and ITP after 1-week of wear. Initial patient subjective assessments provide a clinically useful indicator of the likeliness of success.

Visual Performance in Myopic Adolescents Fitted with Pupil-Optimised Multifocal Soft Contact Lenses

Objective: This study aims to assess the influence of a newly developed pupil-optimized multifocal soft contact lens (MFSCL) in comparison to single-vision contact lenses (SVCL) on visual performance among adolescent myopes. Materials and Methods: Myopic adolescents, aged 14 to 18 years, who were habitual SVCL users, were subjected to a trial involving MFSCL with a mid-addition power. Various visual parameters including distance and near visual acuity (VA), maximum reading speed (MRS), reading acuity, contrast sensitivity, and stereoacuity under photopic conditions were measured for MFSCL and compared to SVCL. Results: No statistically significant differences were observed between SVCL and MFSCL in terms of near VA, MRS, contrast sensitivity, and stereoacuity (p &gt; 0.05 for all). However, a decrease in distance VA was noted with MFSCL (p = 0.021). Moreover, reading acuity, which denotes the smallest print size comprehensible without significant errors, was found to be smaller when using MFSCL (p &lt; 0.001). Conclusion: In adolescent myopic patients, mid-add power in MFSCL did not significantly impact near VA and contrast sensitivity when compared to SVCL, while a decrease in distance VA was observed. Moreover, MFSCL did not affect reading speed but did enable the reading of smaller font sizes.

Relationships Between Success Factors in Daily Disposable Multifocal Contact Lenses.

To explore links between subjective comfort and vision in habitual multifocal soft contact lens (MFCL) wearers when refit with daily disposable MFCLs, to determine which factors are relevant for success with MFCLs and evaluate consistency between MFCLs of different designs. This work examined subjective measures in a randomised, participant masked, bilateral wear crossover study at five optometry practices. Fifty-eight habitual MFCL wearers wore stenfilcon A multifocal (stenA-MF; CooperVision Inc) and delefilcon A multifocal (delA-MF; Alcon) for two-weeks. Subjective ratings included satisfaction with comfort and vision and agreement questions. Agreement with "I would like to wear this MFCL in the future" was taken to indicate success with each MFCL; agreement was significantly higher with stenA-MF. There was strong correlation between agreement responses for "I would like to wear this MFCL in the future" and "MFCL met my needs for vision" with both lenses (p<0.01). However, it was only with stenA-MF, which had higher agreement responses to both statements (p<0.05), that responses to these two statements correlated with satisfaction with end-of-day (EOD) comfort (p<0.01). These differences in correlations between the two lenses are seemingly driven by greater satisfaction with stenA-MF for near and intermediate vision (p<0.05). Subjective vision and comfort were only correlated when vision met the needs of most participants. Meeting participants' needs for vision correlated strongly with wanting to wear a MFCL. Results indicate that meeting vision needs is more important than meeting comfort needs when influencing whether presbyopic patients continue wearing MFCLs.

Efficacy of Multifocal Soft Contact Lenses in Reducing Myopia Progression Among Taiwanese Schoolchildren: A Randomized Paired-Eye Clinical Trial.

To evaluate the efficacy and safety of myopia control using a multifocal soft contact lens designed with high peripheral add power in schoolchildren. This 1-year multi-center, prospective, randomized, double-blind, controlled study enrolled myopic schoolchildren aged 6-15years with refractive errors between - 1.0 D and - 10.0 D. Each participant was randomly allocated to wear a daily disposable multifocal soft contact lens as the treatment in one eye and a single-vision soft contact lens as the control in the other eye. The primary endpoints were changes in the cycloplegic spherical equivalent (SE) and axial length at 1year. Fifty-two of the 59 participants (88.1%) completed the study protocol. The mean change in SE was - 0.73 ± 0.40 D in the treatment group. and - 0.85 ± 0.51 D in the control group (mean difference: - 0.12 ± 0.34 D, p = 0.012). The mean change in axial length was 0.25 ± 0.14mm in the treatment group, and 0.33 ± 0.17mm in the control group (mean difference: 0.08 ± 0.10mm, p < 0.001). The treatment was well tolerated, and no serious adverse events were observed. Treatment with multifocal soft contact lenses with high peripheral add power was effective in controlling the progression of myopia and axial length elongation in myopic schoolchildren.

Systematic Review of Myopia Progression after Cessation of Optical Interventions for Myopia Control.

Despite high discontinuation rates for myopia optical interventions, limited attention has been given to the potential rebound effects post-discontinuation. This systematic review aims to assess the extent of the rebound effects following the cessation of common clinical optical myopia-control interventions in children. A comprehensive search of PubMed, Embase, Cochrane CENTRAL, and ClinicalTrials.gov was conducted from inception to October 2023. The rebound effects, defined as changes in the axial length or spherical equivalent during and after treatment cessation, were categorized into four levels. These studies encompassed 703 participants and spanned from 2019 to 2023, with durations of treatment and cessation ranging from 6 months to 3.5 years and from 2 weeks to 5 years, respectively. This review, encompassing 14 studies, revealed a predominant strong rebound effect in orthokeratology (8 studies), a weak rebound effect in multifocal soft contact lenses (4 studies), and a variable rebound effect in peripheral-plus spectacle lenses (2 studies). Notably, with the increasing cessation duration, the rebound effects diminished, potentially linked to the reversal of choroidal thickening and the disappearance of peripheral myopic defocus. In conclusion, a temporal trend of rebound effects exists in all three myopia optical interventions, possibly contributing to their myopia control mechanisms.

Peripheral Defocus, Pupil Size, and Axial Eye Growth in Children Wearing Soft Multifocal Contact Lenses in the BLINK Study.

The purpose of this study was to evaluate the relationship between peripheral defocus and pupil size on axial growth in children randomly assigned to wear either single vision contact lenses, +1.50 diopter (D), or +2.50D addition multifocal contact lenses (MFCLs). Children 7 to 11 years old with myopia (-0.75 to -5.00 D; spherical component) and ≤1.00D astigmatism were enrolled. Autorefraction (horizontal meridian; right eye) was measured annually wearing contact lenses centrally and ±20 degrees, ±30 degrees, and ±40 degrees from the line of sight at near and distance. Photopic and mesopic pupil size were measured. The effects of peripheral defocus, treatment group, and pupil size on the 3-year change in axial length were modeled using multiple variables that evaluated defocus across the retina. Although several peripheral defocus variables were associated with slower axial growth with MFCLs, they were either no longer significant or not meaningfully associated with eye growth after the treatment group was included in the model. The treatment group assignment better explained the slower eye growth with +2.50 MFCLs than peripheral defocus. Photopic and mesopic pupil size did not modify eye growth with the +2.50 MFCL (all P ≥ 0.37). The optical signal causing slower axial elongation with +2.50 MFCLs is better explained by the lens type worn than by peripheral defocus. The signal might be something other than peripheral defocus, or there is not a linear dose-response relationship within treatment groups. We found no evidence to support pupil size as a criterion when deciding which myopic children to treat with MFCLs.

Invited Session II: Myopia and myopia control: Ocular growth regulation and the complexities of optical defocus decoding: A perspective from studies in chicks.

The COVD pandemic has seen a further rise in the prevalence of myopia world-wide, adding to the urgency of effective treatments that can prevent or slow myopia progression. In addition to multifocal soft contact lenses and orthokeratology lenses for myopia control, a variety of novel spectacle lenses involving modified peripheries are either currently under clinical trial or recently approved. Yet still unresolved questions related to underlying retinal mechanisms of action represent handicaps to their further refinement and improved efficacy. In this presentation, results will be presented from studies using young chicks as a model for manipulating the amount, retinal location and timing of imposed optical defocus, as well as the spatial frequency content of retinal images (with Bangerter foils), by way of offering some additional insights into mechanisms. The predictive values of choroidal thickness changes, as well as eye shape changes, as determinants of "myopia control", will also be considered.

Quality of life after wearing multifocal contact lenses for myopia control for 2 weeks in the BLINK Study.

To validate Pediatric Refractive Error Profile 2 (PREP2) subscales that can be used to evaluate contact lens wearers and compare vision-specific quality of life measurements between children wearing multifocal and single vision contact lenses for 2 weeks. Two hundred and ninety-four myopic children aged 7-11 years (inclusive) were enrolled in the 3-year, double-masked Bifocal Lenses In Nearsighted Kids (BLINK) Study. Participants completed the PREP2 survey after having worn contact lenses for 2 weeks. The Vision, Symptoms, Activities and Overall PREP2 subscales were used to compare participants' subjective assessment while wearing +1.50 or +2.50 D add multifocal or single vision contact lenses. Rasch analysis was used to validate each subscale and to compare participants' subjective assessment of contact lens wear. Item fit to the Rasch model was good for all scales, with no individual items having infit mean square statistics outside the recommended range (0.7-1.3). Response category function was acceptable for all subscales, with ordered category thresholds. Measurement precision, assessed by the Rasch person reliability statistic, was less than ideal (≥0.8) for three of the subscales, but met the minimum acceptable standard of 0.5. Scores for the Vision subscale differed by treatment assignment (p = 0.03), indicating that participants with the highest add power reported statistically worse quality of vision, although the difference was only 3.9 units on a scale of 1-100. Girls reported fewer symptoms than boys (p = 0.006), but there were no other differences between boys and girls. Rasch analysis demonstrates that the PREP2 survey is a valid instrument for assessing refractive error-specific quality of life. These results suggest that vision-related quality of life is not meaningfully affected by 2 weeks of soft multifocal contact lens wear for myopia control.

Accommodation in Children after 4.7 Years of Multifocal Contact Lens Wear in the BLINK Study Randomized Clinical Trial.

When worn for myopia control in children, soft multifocal contact lenses with a +2.50 D add reduced the accommodative response over a 3-year period, but wearing them for more than 4 years did not affect accommodative amplitudes, lag, or facility. This study aimed to compare the accommodative response to a 3D stimulus between single-vision, +1.50-D add, and +2.50-D add multifocal contact lens wearers during 3 years of contact lens wear and then to compare accommodative amplitude, lag, and facility between the three groups after an average of 4.7 years of wear. Bifocal Lenses In Nearsighted Kids study participants aged 7 to 11 years old were randomly assigned to wear single-vision, +1.50-D add, or +2.50-D add soft contact lenses (CooperVision, Pleasanton, CA). The accommodative response to a 3D stimulus was measured at baseline and annually for 3 years. After 4.7 years, we measured objective accommodative amplitudes, lead/lag, and binocular facility with ±2.00-D flippers. We compared the three accommodative measures using multivariate analysis of variance (MANOVA), adjusting for clinic site, sex, and age group (7 to 9 or 10 to 11 years). The +2.50-D add contact lens wearers exhibited lower accommodative response than the single-vision contact lens wearers for 3 years, but the +1.50-D add contact lens wearers exhibited only lower accommodative response than did the single-vision contact lens wearers for 2 years. After adjustment for clinic site, sex, and age group, there were no statistically significant or clinically meaningful differences between the three treatment groups for accommodative amplitude (MANOVA, P = .49), accommodative lag (MANOVA, P = .41), or accommodative facility (MANOVA, P = .87) after an average of 4.7 years of contact lens wear. Almost 5 years of multifocal contact lens wear did not affect the accommodative amplitude, lag, or facility of children.

Role of 7-methylxanthine in myopia prevention and control: a mini-review.

Myopia is becoming increasingly common. By 2050 around 10% of the world's population is expected to be highly myopic (<-5 diopters) and therefore particularly at risk of suffering from sight-threatening complications. Currently used myopia control treatments, such as multifocal soft contact lenses or spectacle lenses, orthokeratology, and atropine eyedrops, either do not completely arrest myopia progression or are associated with significant ocular and possibly systemic side effects. A new candidate for pharmaceutical control of myopia progression and excessive eye elongation, the non-selective adenosine antagonist 7-methylxanthine (7-MX), appears to be non-toxic and effective in reducing myopia progression and axial eye growth in experimental and clinical studies. The latest findings regarding 7-MX for myopia control and evaluate its potential as a supplement to existing treatment options were reviewed.