What Are Multifocal Contact Lenses – Before embarking on this educational marathon of soft multifocal lens research, it is important to acknowledge that reporting myopic function is still an area we are learning about. Specifically, the efficacy rate is influenced by the length of the study (usually shorter studies = higher %), the age of the control group (younger age = lower %), and the rate of progression of the control group (faster = higher %). This is why, in the world of myopia research, you may sometimes find yourself comparing apples to oranges rather than eyeball to eyeball. There’s still a lot of research to be done and things we want to help you understand about this topic, but for now we’re using a percentage as a comparison. Let’s explore a range of studies in terms of what we’ve learned from them – you’ll be surprised to see that all these studies have taken place in the last decade, so it’s a diverse but relatively new field.
Possibly the first study of a new MFCL design, bifocal obstruction in the assessment of myopia in New Zealand (DIMENZ)
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A 2011 study looked at autorefraction and axial length in forty children. They wore a new bifocal lens for 10 months in one eye and a monofocal lens in the other, then switched the methods to the other eye. The lens tested had a center distance design with two alternating concentric distance zones and +2.00 Add, which simultaneously produced retinal detachment. They found a 36% reduction in refractive progression in the bifocal lens and a 50% reduction in axial elongation. We now know this lens as the CooperVision MiSight.
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Because the study was monocular, the results showed a strong effect in the treated eye and led to a three-year randomized controlled trial of MiSight, which we describe in more detail below.
New Lens Study 2011, Reduction in the rate of myopia progression with contact lenses designed to reduce relative peripheral farsightedness: one-year results, by Sankaridurg et al. used lenses with an effective peripheral magnification of +2.00D. 45 Chinese children between the ages of 7 and 14 followed an eight-hour regimen and showed a 33% reduction in axial length change and a 30% reduction in myopia progression.
This was compared to 40 controls who wore monocular glasses. Lens wearers only did this five days a week, which clinically tells us that if patients want to take a weekend off from wearing lenses, the treatment effect may still be sufficient.
More was learned about the relationship between wear time and activity in the Defocus Incorporated Soft Contact (DISC) study. This study evaluated changes in refraction and axial length in 221 children with a new lens containing a +2.50D focus through multiple concentric rings, alternating with distance correction.
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After two years of follow-up, the DISC group had 25% less myopia progression and 31% less axial length progression than the single vision control group. Interestingly, they found that there was an inverse relationship between the progression of myopia and lens wear time – children who wore the lenses for at least 5 hours a day achieved 46% control, while those who wore the lenses for 7 hours or more a day achieved 58% control. There was no additional benefit at follow-up after eight hours, suggesting that the ideal schedule for MFCL use may be daily wear for at least eight hours.
Presenting at ARVO in 2012, Holden, Sankaridurg and coauthors presented data from the five-year MFCL trial, one of the longest evaluations of treatment effects. Forty children were assigned to either the single-vision control lens or the +1.50D visual field test lens design and were followed for an average of 43 months in the first phase. In the second phase, all children wore the test lens for an additional two years.
The 16 children who remained at the end of five years showed a 39% reduction in refractive error and a 41% reduction in axial elongation. The trial MFCL appeared to maintain efficacy up to 43 months, and children initially in the control group showed a similar reduced rate of progression when fitted with the trial MFCL lens.
Although this study was small, it showed long-term myopia control of nearly 4 years. The longest ongoing study is the five-year MiSight study, where control children were switched from SV to MiSight at years 4 and 5 of the study. This data is not yet published, but we reported it from the 2019 International Myopia Conference – read more here.
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Wallin and coauthors were the first to evaluate commercially available MFCLs—typically prescribed for presbyopes—in their 2013 paper Myopia Control with Multifocal Contact Lenses. Twenty-seven (27) children aged 8-11 years completed the two-year study using the +2.00D Add CooperVision Proclear Multifocal Distance Centered lens and were compared to a historical SV lens wear control group. It showed a 50% reduction in myopia progression and a 29% reduction in axial elongation.
Wallin and co-authors recently released the long-awaited results of the Bifocal Lenses in Myopic Children (BLINK) study – as it is not open access, this link will take you to our analysis of this key article. Comparing CooperVision Biofinity D lenses centered in +1.50 and +2.50 Adds on single-vision lens control, the three-year study found that +2.50 Add had a significant effect while +1.50 Add did not.
If you intend to use the +2.50 allowance in practice, keep in mind that the same authors found that children needed an additional -0.50 lens power above the best field of view to achieve good acuity. Read more about this in Which multifocal soft lens? Refraction and safety.
The 2016 CONTROL study by Aller et al. evaluated 86 progressively myopic subjects aged 8–18 years randomized to use Johnson & Johnson Acuvue concentric bifocal designs or commercially available monofocal lenses. A distinctive feature of this study was that, in the test group, the bipedal CL attachment was chosen based on an attempt to neutralize the associated esophagus in the immediate vicinity. All participants presented with a near esophagectomy, and with this tailored approach, the results in the one-year study were among the highest seen—more than 70% refractive control was reported.
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Since the COMET (Progressive Addition of Spectacle Lenses) study found a greater therapeutic effect of PAL in children with esophagitis and greater delay,
This may explain why the CONTROL study had such strong results. Emphasizes the importance of involving the optician in the treatment of myopia. This study also showed that myopia control can be effective up to age 18, so don’t neglect to offer myopia control to your older patients.
Cheng and coauthors in 2019 published the first paper examining the interplay between the function and control of myopia in MFCL. They looked at a new lens design using positive spherical aberration (actually a center distance design) and showed that the test lens reduced the reflex response and this reduced response was associated with a reduced myopia control effect. Interestingly, this relationship was not found in the control group with CL visual correction,
Much remains to be learned about how MFCL affects visual acuity in young users and how this may relate to the effectiveness of myopia control. For now, these studies underscore the importance of assessing and managing the patient’s binocular system—to ensure visual comfort and, as we learn more, perhaps to maximize the effectiveness of myopia control.
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In 2015, Peacock and coauthors evaluated myopia control with a new soft lens (SRRG) compared with orthotics in a two-year study.
This study followed participants for twelve months before starting treatment with a new +2.00 constant additional power soft lens. visual field (semichord 4 mm in diameter).”
The study showed a reduction in the progression of myopia by 43% when using the new soft lenses and 67% when using OK lenses. Although the percentages appear different, the overall refractive difference of 0.42D less myopia at two years in SRRG and 0.66D less in OK wearers compared to SV was not significantly different. This was confirmed when looking at the axial length data, which were also similar in SRRG and OK. This is the only study published to date that directly compares MFCL and OK, confirming that both have similar efficacy in controlling myopia. Read more about this in Myopia Management Message Part 2 – Efficacy.
Presented as an abstract at ARVO 2018, Cheng, Xu and Brennan presented data on “simOK” soft contact lenses compared to a single contact lens control. After one year, the axial length had slowed by only 9% and there was no change in refraction. Being only abstract, the design “simOK” said to “simulate the visual effect of OK on the eye” was not further described. It is not known whether the anterior visual profile or the peripheral one
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