Myopia Control Study Research Articles

High myopia: Reviews of myopia control strategies and myopia complications.

Myopia and especially high myopia are recognised as major public health concerns. Although the prevalence of high myopia in young children is low, 10-20% of high school children in Asia have high myopia, with many still progressing, and one in three patients with high myopia develop visual impairment with age. Most participants in myopia control studies have low and moderate myopia; relatively little is known about myopia control in high myopia. Literature searches were undertaken in MEDLINE and EMBASE to identify publications in English, investigating (Aim 1) the efficacy of myopia control strategies (environmental, pharmacological and optical) in high myopia (≤-6.00 D) and (Aim 2) the complications of high myopia using keywords. Outcomes included change in spherical equivalent refractive error (SE) and/or axial length (AL) to evaluate progression in high myopia. Aim 1: Twelve studies were identified that reported the efficacy of optical and pharmacological (none on environmental) interventions on AL and SE for high myopia control. A statistically significant reduction in progression of SE and AL in high myopes was reported with 1% and 0.5% atropine. Defocus Incorporated Multiple Segment spectacle lenses had lower efficacy in slowing high myopia progression compared to moderate and low myopia. Ortho-K lenses were equally effective in reducing myopia progression in low, moderate and high myopia. Aim 2: Myopic patients have an increased risk of myopic macular degeneration, retinal detachment, cataract and glaucoma, with the risk increasing with the level of myopia. High myopia has significant effects on quality of life, risk of pathological complications and vision impairment. Young children, excluding those with some syndromic associations, who are fast progressing moderate and high myopes require early intervention and close monitoring. Further research investigating the efficacy of myopia control strategies in highly myopic patients, both independently and through combination treatments, are necessary.

Baseline Accommodation and Binocular Vision Measures in Malay Schoolchildren Enrolled in the Myopia Control Study Using Spectacle Lenses in Kuala Lumpur.

Myopia control lenses have been shown to modify visual function; however, it is arguable if these changes are short-term or long-term. We investigated the changes in accommodative behaviour and binocular vision functions of Malay myopic children who participated in a myopia control trial utilising spectacle lenses (n = 40). This article presents baseline accommodation and binocular vision measurements. The mean (± SD) age, spherical equivalent measured by cycloplegic autorefraction, and axial length (AL) for the right eyes were 10.00 ± 1.47 years, -3.02 ± 1.20 D, and 24.42 ± 0.93 mm, respectively. All participants had good distance and near visual acuities with high-contrast charts (100%), which were significantly better than low-contrast charts (10%) (p < 0.001). The mean (± SD) accommodative lag at baseline was 1.14 ± 0.35 D, while monocular and binocular accommodative amplitudes were 15.35 ± 2.07 D and 16.82 ± 2.27 D, respectively. Malay schoolchildren in this study were more esophoric at near compared to distance, with an accommodative-convergence over accommodation (AC/A) ratio of 5.64 ± 0.66 ∆/D. A higher degree of myopia was found to be associated with a longer AL (r = -0.49, p < 0.05) and higher esophoria at near (r = -0.46, p < 0.05). These baseline measures are consistent with data from other studies showing that myopic children have a high accommodative lag, an elevated AC/A ratio, a longer AL, and are more esophoric at near. The measures reported herein will serve as a basis for examining changes that occur within 12 months of wearing myopia control spectacle lenses.

Age-related results over 2 years of the multicenter Spanish study of atropine 0.01% in childhood myopia progression

To evaluate the age-related efficacy and safety of atropine 0.01% eye drops over 2 years for myopia control in a multicentric pediatric Spanish cohort. A non-controlled, interventional, prospective multicenter study was conducted as an extension of the Spanish Group of Atropine Treatment for Myopia Control Study (GTAM 1). Children aged 6–14 years with myopia from − 2.00 to − 6.00 D, astigmatism < 1.50 D and documented annual myopic progression of at least − 0.50 D under cycloplegic examination were recruited. From the original cohort of 105 participants, 92 children who had been receiving atropine 0.01% eye drops once nightly in each eye for 1 year continued their participation in this extended study (GTAM 2). All the patients underwent a standardized quarterly follow-up protocol, which included measurements of best-corrected visual acuity (BCVA), cycloplegic autorefraction, axial length (AL), anterior chamber depth (ACD), and pupil diameter. The study sample was divided into three age groups: 6–8, 9–11, and 12–14 years old. The mean change in cycloplegic spherical equivalent (SE) and axial length (AL) during the 24 months of follow-up was analyzed. Correlations between SE and AL, as well as the distribution of annual progression, were evaluated. Adverse effects were recorded using a specific questionnaire. Finally, 81 children completed the follow-up and were included in the analysis. Over the 2-year period, the mean changes in SE and AL were − 0.88 ± 0.60 D and 0.49 ± 0.25 mm, respectively. Additionally, 51 patients (63%) experienced SE annual progression lower than − 0.50 D. The correlation between the progression of SE and AL during the total period of treatment was mild (r = − 0.36; p < 0.001). There were no differences between the first and the second year of treatment in the progression of SE (− 0.42 ± 0.41 D versus − 0.45 ± 0.39 D; p = 0.69) or AL (0.25 ± 0.16 mm versus 0.23 ± 0.14 mm; p = 0.43). Older patients (12–14 years old) showed less AL progression than younger children (6–8 years old): 0.36 ± 0.18 mm versus 0.59 ± 0.30 mm; p = 0.01. Adverse effects were mild, infrequent, and decreased over time. On average, the myopia progression in control groups from other published biannual studies exceeded that observed in our study. Over 2 years, atropine 0.01% demonstrated a safe treatment for controlling myopia progression in a multicentric cohort of Spanish children. The effect remained stable during this period. Older patients exhibited a more favorable response in terms of AL enlargement. However, further studies are needed to investigate the age-related effect of low-dose atropine in the Caucasian population.

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

PurposeTo 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. MethodsA 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. ResultsThroughout 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. ConclusionsChildren 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.

Multifocal Contact Lenses and 0.01% Atropine Eye Drops for Myopia Control Study: Research Protocol for a 1-Year, Randomized, Four-Arm, Clinical Trial in Schoolchildren.

Previous studies have shown that combined use of orthokeratology and 0.01% atropine (AT) eye drops can strongly prevent axial elongation in myopic children. However, the efficacy of combined use with multifocal contact lens (MFCL) and 0.01% AT remains unclear. The aim of this trial is to clarify the efficacy of MFCL+0.01% AT combination therapy for myopia control and safety. This prospective study is a randomized, double-masked, placebo-controlled trial with four arms. A total of 240 children aged 6 to 12 years with myopia is recruited and randomly assigned to one of the four groups in a ratio of 1:1:1:1 as follows: group 1: MFCL+AT combination therapy, group 2: MFCL monotherapy, group 3: AT monotherapy, and group 4: placebo. The participants will continue the assigned treatment for 1 year. The primary and secondary outcomes are the comparisons of axial elongation and myopia progression in the four groups during the 1-year study period. The present trial would determine whether the MFCL+AT combination therapy is more effective in slowing axial elongation and myopia progression in schoolchildren as compared with each monotherapy or placebo, and it also confirm acceptable safety of the combination therapy.

Comparing children's, teenagers' and young adults' subjective responses to myopia control contact lenses.

Myopia control (MC) studies in children link efficacy with subjective performance. There is little MC research in teenagers and young adults. This study compared subjective experience of MC contact lenses in different age groups. Data were retrospectively reviewed from two double-masked, bilateral wear, crossover contact lens clinical trials (myopia -0.75D to -3.50D and <1.00 DC; 9-35 years). Participants wore two novel lenses (MC lenses with relative peripheral plus [+1.50D and +2.50D]) and a single-vision (SV) control lens (Clariti® 1day) for 1 week each. All lenses were made from Somofilcon A material. Data collected included visual acuity (VA), wearing time, subjective ratings of comfort, distance and near vision clarity and overall vision. Generalised estimating equations with subject random intercepts and identity link functions were used in the analysis. A total of 31 participants (10 children, 11 teenagers and 10 adults) were included, with no difference between the age groups for VA with the dispensed lenses (p > 0.05). All groups could discriminate between the SV and MC lenses for vision (distance, near and overall) after 1 week (p < 0.05). There was no difference between groups for comfort or distance and near vision. Children rated the overall vision quality higher than teenagers and adults for both SV and MC lenses (p < 0.05), but there was no difference relative to the SV lens between groups (p > 0.50). Daily wear time was lowest for children for all lens types (all p < 0.02). Wear time was positively associated with ratings of overall vision quality for children and young adults (both p < 0.05). All age groups rated SV lenses higher than MC lenses. Subjective ratings of MC lenses appear similar between age groups relative to SV lenses. Wear time was lowest in children and was correlated with overall vision quality ratings in children and young adults.

Ocular signs and symptoms of orthokeratology patients associated with povidone iodine-based disinfecting solution

PurposeTo determine the frequency and severity of ocular symptoms and signs in new orthokeratology (ortho-k) subjects using a povidone iodine (PI) disinfecting system compared to those present before lens wear, and whether these were associated with cleaning regimes. MethodsThis study recruited 80 subjects from two myopia control studies, who used a PI disinfecting solution for routine use. Ocular symptoms and signs at baseline, one- and six-month after lens wear were reported via questionnaires and ocular examination, respectively. To determine if rates of occurrence were attributable to differences in cleaning regime, subjects were randomly assigned into four groups with respect to routine care procedures, which involved various combinations of rubbing and use of a daily and/or enzymatic cleaner. ResultsSixty-eight subjects completed all aspects of the study. As there were no significant differences in incidence of signs and symptoms between the four groups before and after lens wear (Friedman tests, p > 0.07), data were combined for further analysis. Prior to lens wear, itchiness (69 %) and dryness (53 %) were the most commonly reported symptoms. The frequency and severity of all symptoms remained similar after lens wear (p > 0.10). Presence of follicles in the lower tarsal conjunctiva (22 %) and conjunctival injection (15 %) was frequently observed, but reduced significantly after lens wear (p < 0.01). Mild corneal staining, noted in 13 % of subjects at baseline, did not change significantly over time (p = 0.17). Ocular signs were not necessarily reflected in symptoms and vice versa. ConclusionUse of a PI-based solution did not increase the frequency or severity of ocular signs and symptoms observed before lens wear. Absence of a difference in occurrence of ocular discomfort with respect to cleaning regimes indicated that the use of the PI-based solution may adequately clean the lenses over a 6-month period.

Combined 0.01% atropine with orthokeratology in childhood myopia control (AOK) study: A 2-year randomized clinical trial

BackgroundTo investigate whether combining 0.01% atropine with orthokeratology (AOK) has a better effect in retarding axial elongation, compared with orthokeratology alone (OK) over two years. MethodsA total of 96 Chinese children aged six to < 11 years with myopia (1.00 – 4.00 D, inclusive) were randomized into either the AOK or OK group in a 1:1 ratio.Axial length (the primary outcome), and secondary outcomes (e.g. pupil size and choroidal thickness) were measured at 1-month and at 6-monthly intervals after commencement of treatment. ResultsBoth intention-to-treat and per-protocol analyses showed significantly slower axial elongation in the AOK group than OK group over two years (P = 0.008, P < 0.001, respectively). AOK subjects had statistically slower axial elongation (adjusted mean [standard error], 0.17 [0.03] mm vs 0.34 [0.03] mm, P < 0.001), larger increase in mesopic (0.70 [0.09] mm vs 0.31 [0.09] mm, P = 0.003) and photopic pupil size (0.78 [0.07] mm vs 0.23 [0.07] mm, P < 0.001), and greater thickening of the choroid (22.6 [3.5] µm vs −9.0 [3.5] µm, P < 0.001) than OK subjects over two years. Except for a higher incidence of photophobia in the AOK group (P = 0.006), there were no differences in the incidence of any other symptom or adverse events between the two groups. Slower axial elongation was associated with a larger increase in the photopic pupil size and a greater thickening in the choroid in the AOK group. ConclusionsSlower axial elongation following 2-year AOK treatment may result from increased pupil dilation and a thickening in the choroid observed in the AOK group.

One-year results of 0.01% atropine with orthokeratology (AOK) study: a randomised clinical trial.

To report the 1-year results of an investigation into whether there is an additive effect between 0.01% atropine and orthokeratology (ortho-k), in a single-masked, two-arm, randomised controlled trial: Combined Atropine with Orthokeratology (AOK) for myopia control study (ClinicalTrials.gov number: NCT02955927). Chinese children aged between 6 and 11years with 1.00-4.00 D of myopia, astigmatism <2.50 D, and no more than 1.00 D anisometropia, were randomly assigned either to an AOK group or ortho-k only (OK) group at a 1:1 ratio. Subjects in the AOK group instilled one drop of 0.01% atropine into each eye, 10min before nightly wear of ortho-k lenses. The primary outcome, axial elongation, was examined at 6-monthly intervals, along with secondary outcomes including best-corrected visual acuity (BCVA), manifest refraction, accommodation, pupil size, and corneal topography. 29 AOK and 30 OK subjects completed the 1-year visit. The overall axial elongation rate was significantly slower in the AOK group than in the OK group (mean (S.D.), 0.07 (0.16) mm vs 0.16 (0.15) mm, respectively; p= 0.03). A significant between-group difference in axial elongation was observed over the first 6-month period only (p<0.001), but not over the second period (p=0.818). At the 1-year visit, increases in mean (S.D.) mesopic and photopic pupil sizes in the AOK group were 0.64 (0.48) mm and 0.36 (0.34) mm, respectively, which were significantly higher than 0.10 (0.50) mm and 0.02 (0.28) mm in the OK group (p<0.001). At the 6-month visit, a significant moderate negative correlation was found between axial elongation and the increase in photopic pupil size (r = -0.42,p= 0.02) in the AOK group. There is an additive effect between 0.01% atropine and ortho-k over one year, with mean axial elongation in the AOK group 0.09mm slower than that in the OK group. It appears that the additive effect was only during the first six months; a second-year investigation is warranted to determine whether the effect is sustained over time.

Role of corneal biomechanical properties in predicting of speed of myopic progression in children wearing orthokeratology lenses or single-vision spectacles

ObjectiveTo determine the characteristics of children who were likely to progress rapidly and gain the greatest benefit from orthokeratology (ortho-k) treatment.Methods and analysisThe files of 113 children who participated in...

Myopia control studies 3 What is important and why? Part 2

Continuing her discussion of research into myopia control, Dr Kathy Dumbleton describes the design of clinical studies and how clinical research relating to myopia control is evaluated.

Myopia control studies 2 - What is important and why?: Part 1

Dr Kathy Dumbleton continues our series on myopia management with the first in a two part discussion of the research into myopia management

A Randomized Trial of Soft Multifocal Contact Lenses for Myopia Control: Baseline Data and Methods.

The Bifocal Lenses In Nearsighted Kids (BLINK) study is the first soft multifocal contact lens myopia control study to compare add powers and measure peripheral refractive error in the vertical meridian, so it will provide important information about the potential mechanism of myopia control. The BLINK study is a National Eye Institute-sponsored, double-masked, randomized clinical trial to investigate the effects of soft multifocal contact lenses on myopia progression. This article describes the subjects' baseline characteristics and study methods. Subjects were 7 to 11 years old, had -0.75 to -5.00 spherical component and less than 1.00 diopter (D) astigmatism, and had 20/25 or better logMAR distance visual acuity with manifest refraction in each eye and with +2.50-D add soft bifocal contact lenses on both eyes. Children were randomly assigned to wear Biofinity single-vision, Biofinity Multifocal "D" with a +1.50-D add power, or Biofinity Multifocal "D" with a +2.50-D add power contact lenses. We examined 443 subjects at the baseline visits, and 294 (66.4%) subjects were enrolled. Of the enrolled subjects, 177 (60.2%) were female, and 200 (68%) were white. The mean (± SD) age was 10.3 ± 1.2 years, and 117 (39.8%) of the eligible subjects were younger than 10 years. The mean spherical equivalent refractive error, measured by cycloplegic autorefraction was -2.39 ± 1.00 D. The best-corrected binocular logMAR visual acuity with glasses was +0.01 ± 0.06 (20/21) at distance and -0.03 ± 0.08 (20/18) at near. The BLINK study subjects are similar to patients who would routinely be eligible for myopia control in practice, so the results will provide clinical information about soft bifocal contact lens myopia control as well as information about the mechanism of the treatment effect, if one occurs.

Discontinuation of orthokeratology on eyeball elongation (DOEE)

To evaluate and compare changes in axial elongation, over a 14-month period, in subjects who discontinued and then resumed ortho-k lens wear with those who continued to wear their lenses or spectacles following a 2-year myopia control study. This single masked, prospective study recruited subjects who had just completed a 2-year myopia control study. Ortho-k subjects were classified as Group OKc, in which subjects continued ortho-k lens wear for the duration of the study; or Group OKd in which subjects discontinued lens wear for seven months and wore single-vision spectacles (Phase I) and then resumed ortho-k lens wear for another seven months (Phase II). Spectacle-wearing control subjects from the initial myopia control study continued wearing spectacles as control subjects. Axial lengths were measured at scheduled visits using the IOLMaster. Thirteen, 16, and 15 Control, OKc, and OKd subjects, aged 8-14 years, respectively completed the study. Significant increase in axial elongation was found in OKd subjects only in Phase I but not in Phase II. On resuming lens wear, in Phase II, the rate of axial elongation was no longer significantly different from those of the Control or OKc subjects. Stopping ortho-k lens wear at or before the age of 14 years led to a more rapid increase in axial length; comparable to those wearing spectacles during the initial 2-year myopia control study, but greater than the Control and OKc group in this study. Axial elongation slowed again with resumed lens wear after six months.

Parents' knowledge and perspective of optical methods for myopia control in children.

To solicit parents' knowledge on myopia control strategies available; to investigate their attitudes toward the use of orthokeratology (ortho-k), daily wear soft lenses, and spectacles for myopia control, assuming all three optical strategies were equally effective for myopia control; and to collect their opinion on the age at which children can commence contact lens wear for vision correction. Telephone interviews were conducted on parents who responded to the advertisement for two myopia control studies, one on ortho-k and one on soft lenses. Most of the 196 respondents (ortho-k group, 56%; soft lens group, 44%) were mothers, aged 36 to 45 years. Ortho-k was the most commonly known myopia control strategy (86%). Parents in the ortho-k group selected ortho-k (49%) and spectacles (45%) (p < 0.001) as their preferred myopia control strategy, whereas parents in the soft lens group had no preference (p = 0.57). Decision was affected by prior knowledge of myopia control strategy. Major considerations were convenience and safety among parents selecting contact lenses and spectacles, respectively, as their preferred options. Overall, because of the lack of confidence in safety in contact lens wear, most parents (75%) were of the opinion that contact lenses for vision correction were only for children older than 14 years (53%) and not indicated for children younger than 8 years. Parents in Hong Kong were open to the use of contact lenses for myopia control in young children and they appeared to regard myopia control contact lenses as "treatment" and not as visual aids. They were more conservative in the use of contact lenses for vision correction in children. Parents' decision in selecting a myopia control strategy, assuming all three strategies to be equally effective, was affected by an individual's concerns of safety and additional benefits as well as influenced by positive evidence on myopia control effects.

Comparaison de la morbidité de 2 prélèvements des tendons de la patte d’oie pour la reconstruction de ligament croisé antérieur

To determine the prevalence of papillary changes of the upper palpebral conjunctiva and folliculosis of the lower palpebral conjunctiva in Chinese children with no history of contact lens wear.Ninety-nine subjects (aged 6–15 years old) who were interested in a myopia control study were screened for papillary changes and folliculosis of the palpebral conjunctiva. Photodocumentation was performed under white and blue light (after the application of fluorescein) with a yellow filter and the photographs were graded by a group of practitioners according to a pre-set grading scale. Analysis was performed with the subjects divided into groups according to gender and age.More than 48% of the subjects had clinically significant (≥Grade 3) papillary changes in the upper palpebral conjunctiva. The prevalence of significant folliculosis in the lower lid was about 33%. The prevalence of significant papillary changes and folliculosis were similar between genders. No differences were observed between younger (age ≤ 10 years old) and older (age > 10 years old) in papillary changes but younger subjects showed a higher prevalence of folliculosis.The prevalences of clinically significant papillary changes and folliculosis of unknown aetiology are high in Chinese children.

Prevalence of papillary changes and folliculosis of the palpebral conjunctiva in asymptomatic Chinese children

To determine the prevalence of papillary changes of the upper palpebral conjunctiva and folliculosis of the lower palpebral conjunctiva in Chinese children with no history of contact lens wear. Ninety-nine subjects (aged 6-15 years old) who were interested in a myopia control study were screened for papillary changes and folliculosis of the palpebral conjunctiva. Photodocumentation was performed under white and blue light (after the application of fluorescein) with a yellow filter and the photographs were graded by a group of practitioners according to a pre-set grading scale. Analysis was performed with the subjects divided into groups according to gender and age. More than 48% of the subjects had clinically significant (≥Grade 3) papillary changes in the upper palpebral conjunctiva. The prevalence of significant folliculosis in the lower lid was about 33%. The prevalence of significant papillary changes and folliculosis were similar between genders. No differences were observed between younger (age≤10 years old) and older (age>10 years old) in papillary changes but younger subjects showed a higher prevalence of folliculosis. The prevalences of clinically significant papillary changes and folliculosis of unknown aetiology are high in Chinese children.

18 Clinical performance of the defocus incorporated soft contact (DISC) lens in a two year myopia control study

18 Clinical performance of the defocus incorporated soft contact (DISC) lens in a two year myopia control study

Corneal reshaping and myopia progression

Background/aims:Anecdotal evidence indicates that corneal reshaping contact lenses may slow myopia progression in children. The purpose of this investigation is to determine whether corneal reshaping contact lenses slow eye growth.Methods:Forty...

Use of a run-in period to decrease loss to follow-up in the contact lens and myopia progression (CLAMP) study

Rigid gas permeable (RGP) contact lenses are initially less comfortable to wear than spectacles. In previous studies evaluating the use of RGP contact lenses to control myopia, more subjects randomly assigned to wear RGP contact lenses have been lost to follow-up than spectacle wearers. Previous rigid contact lens myopia control studies have lost 44% and 47% of the rigid contact lens wearers. This unequal loss to follow-up may compromise the results of the study, so we conducted a run-in period prior to randomized treatment-group assignment to ensure that all participants could adapt to RGP contact lens wear. We enrolled 147 children ages 8–11 years with myopia in the run-in period. Of the 147 subjects, 116 (78.9%) were able to wear RGP contact lenses for at least 40 hours per week and reported that they were “usually comfortable” or “always comfortable.” After 3 years, no subjects were lost to follow-up. The run-in period greatly reduced the loss to follow-up suffered by previous RGP contact lens myopia progression studies and may help provide more definitive answers regarding myopia control with RGP contact lenses.