Review clinical highlights of new myopia control lens

December 10, 2019

By Jennifer Palombi, OD, FAAO
Kathy Dumbleton, BSc (Hons), MSc, PhD, MCOptom, FAAO, FBCLA

Article

Daily disposable MiSight offers new option for parents, children, ODs

The prevalence of myopia is increasing at an unprecedented rate worldwide with current estimates at 23 percent of the world’s population and a predicted increase to almost 50 percent by 2050.¹ In the U.S., prevalence of myopia has nearly doubled from 25 percent to 42 percent over the last two generations.²
The debilitating consequences of myopia-associated pathology help to explain why is not surprising that eyecare professionals (ECPs) in the U.S. and around the world have become increasingly concerned for their young myopic patients and are eager to discuss management options with their patients’ parents.³

Myopia control with contact lenses
In recent times, there have been many studies aimed at reducing myopia progression with optical methods such as progressive addition lenses (PAL), overnight corneal reshaping contact lenses (orthokeratology), and soft contact lenses incorporating multifocal or aspheric optics.^4-16

With respect to mechanisms that regulate refractive error development, hyperopic defocus has been shown to encourage eyeball growth; a consequence of which is increasing axial length and myopia¹⁷ that ultimately may result in regular prescription changes. In contrast, myopic defocus can retard eye growth.¹⁸

A number of studies have shown that use of simultaneous optics can control axial elongation and myopia.^19-25 These simultaneous optics are typically concentric alternating powers of distance correction and myopic defocus, often called “dual-focus” optics. These optics have been investigated in contact lenses. In clinical practice, dual focus lenses are designed to minimize hyperopic defocus or to induce myopic defocus while also allowing simultaneous correction of the child’s current refractive error. This may help to control the progression of myopia.

A study by Anstice and Phillips⁷ evaluated dual-focus soft contact lenses in children aged 11 to 14 years. This study reported that following 10 months, the change in spherical equivalent refraction (SE) and axial length (AL) in the eye wearing the dual focus lens was significantly less than that in the contralateral eye wearing the single-vision lens (SE: -0.44 D vs. -0.69 D; AL: 0.11 mm vs. 0.22 mm).

MiSight 1 day lenses
MiSight 1 day myopia management contact lenses (CooperVision) were approved in the U.S. in November 2019, are manufactured using omafilcon A material, and implement a dual focus design.

Four alternate rings of power are used to correct existing myopia and to create myopic defocus over the entire retina. MiSight 1 day features a central distance correction zone for clear vision with a concentric treatment zone introducing myopic defocus. A further distance and treatment ring completes the design (Figure 1).⁷

The results of a randomized, three-year clinical study into the effectiveness of MiSight 1 day have been presented in recent years at key global clinical conferences and have been published in Optometry and Vision Science.²⁶ This article summarizes the key findings from that research and other work presented at key conferences on the lens’ performance.

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Study outline
The study enrolled 144 children who were randomly assigned to the control group or the treatment group. The treatment group wore MiSight 1 day (n=70), and the control group wore Proclear 1 day (omafilcon A, CooperVision; n=74), these interventions were identical in all respects apart from optical design (see Table 1).

To help ensure that the children recruited to the study were ethnically diverse, four clinical research sites located in the United Kingdom, Canada, Portugal, and Singapore were chosen. Myopic children with no prior contact lens experience were recruited with specific inclusion criteria (see Table 2).
The investigators, children, and parents were unaware of which group participants had been assigned to for the duration of the study due to a rigorous randomization and masking procedure. Further, both groups were recruited to be extremely well matched with no significant differences between the groups for all factors considered to be important in myopia control (see Table 3).

The children were instructed to wear the assigned contact lenses on a daily disposable basis for a minimum of 10 hours per day at least six days per week for the duration of the study. Follow-up visits were scheduled after one week and one, six, 12, 18, 24, 30, and 36 months.
Some 109 children who were dispensed lenses completed the clinical trial (53 wearing MiSight 1 day, 56 wearing Proclear 1 day) which represents an extremely high retention rate for a study of this nature and duration.

Key findingsRefractive error and axial length
Cycloplegic refractive error (SERE) and AL were measured at baseline, 12-month, 24-month and 36-month visits.²⁶ Open-field autorefraction was conducted with a Grand Seiko autorefractor, and AL was measured using a Zeiss IOLMaster. The results for the change in SERE and AL for the MiSight 1 day and Proclear 1 day groups are shown graphically in Figures 2 and 3, respectively.

As is typical in studies of this nature, a linear mixed model was applied to account for study group imbalances that could possibly affect the primary outcome measures, for example age, gender, and site location. However, the results of the linear mixed model analysis did not significantly change the primary outcome results; as such, we present only the unadjusted data here.

The distribution of individual eye responses for the change in SERE after 36 months for both the MiSight 1 day and Proclear 1 day groups are presented in Figure 4.

These results show that 41 percent of the eyes in the children wearing the MiSight 1 day showed no myopia progression (≤0.25 D SERE change) as compared with only four percent of the eyes in the children wearing the Proclear 1 day lens. In contrast, 62 percent of the eyes of the children wearing the Proclear 1 day lens had progressed by more than –1.00 D as compared with only 18 percent of the eyes in the children wearing MiSight 1 day.

In practice, with a similar population of children wearing MiSight 1 day, a significant proportion could see their myopia progression halted, although managing expectations with parents and children in practice will need a careful approach.

Handling, comfort, vision

By one month, over 80 percent of the children from both the test and control groups described contact lens application as “kind of easy” or “really easy.” Similarly, more than 90 percent of children reported that contact lens removal was “kind of easy” or “really easy” for all study visits. This demonstrates that children from the age of 8 are able to confidently handle their contact lenses soon after the initial fitting.

Presenting visual acuity with contact lenses varied slightly at follow-up visits as seen in Figure 5.

However, with spherical over-refraction, best-corrected visual acuity with contact lenses remained similar for the two lens types and better than 20/20 for each follow-up visit. Questionnaire responses correlated with these findings with over 90 percent of children agreeing that MiSight 1 day gave them clear vision at a variety of distances during everyday activities including playing outdoors, schoolwork, reading, and watching television, with nine out of 10 children preferring their MiSight 1 day lenses to wearing their spectacles.

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MiSight 1 day in clinical practice

The key findings of this three-year clinical study demonstrate that MiSight 1 day contact lenses were effective in reducing both the progression of myopia and the associated increase in axial length over the 36-month study period. It is reassuring that the controlling effects on both the refractive error progression and the axial length elongation persisted throughout the study period.

A reduction in the natural progression of myopia during childhood and adolescence will result in a lesser degree of myopia after stabilization with associated ocular health and quality of life benefits.^27,28

In addition to myopia control benefits, contact lens wear in children and teens has been reported to offer advantages in social settings, for sports activities, and to improve self-esteem when compared with spectacle wear.^30,31 These findings were supported in this study with nine out of 10 children expressing a preference for contact lenses compared to their spectacles.

The children taking part in the study were generally able to handle their contact lenses independently of their parents, consistent with reports from other studies.^32,33 This supports the findings of a recently conducted survey in which ECPs worldwide considered children aged 8.8 years to be old enough for myopia control contact lenses, with ECPs across North America reporting a minimum age of 7.9 years.³

No serious or significant ocular complications were reported during the three-year study period. This supports current evidence that soft contact lens wear in children is as safe and possibly even safer than in teenagers and adults.^34,35

The MiSight 1 day clinical study is now in its sixth year-the longest continuous contact lens study-with five-year data presented at the American Academy of Optometry annual meeting in October 2019. All children wearing Proclear 1 day (control) have been moved to MiSight 1 day to help understand the impact of MiSight 1 day in an older population of children. The children in both groups showed similar rates of progression through Years Four and Five in both refractive error and axial length growth.³⁶

At the same meeting, data were presented on the wearer experience and subjective responses comparing the dual focus and spherical daily disposable lenses from the study.³⁷ Subjective responses with MiSight 1 day were similar to those with the equivalent single-vision spherical lens, and most vision ratings were consistently high, similar for both lens types and equally liked.

The children aged eight to 15 demonstrated a high level of capability with wearing contact lenses and were highly satisfied with the comfort, vision, and handling performance of both MiSight 1 day and Proclear 1 day. All children had a significant preference for contact lenses over spectacles, emphasizing their success with soft, daily disposable lenses.

Conclusion

Being a daily disposable lens, MiSight 1 day offers well-documented advantages over reusable lenses^38,39 and is widely considered to be an ideal option for children and teens. With MiSight 1 day, ECPs now have the option of prescribing an easy-to-fit contact lens to help manage myopia progression in their young patients.
Intervention at an early age, when the amount of myopia is low, should be discussed with all parents.

This article is based on an article published in Optician, UK: Chamberlain P, Dumbleton K, Lumb E. Clinical Evaluation of MiSight 1 day Contact Lens for Myopia Control: Three-Year Milestone Results. Optician. 06 September 2019 pages 28-33.

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