Global group consolidates myopia research efforts

Members of the International Myopia Institute have taken the first step in making their research available to clinicians, governments, policy makers, educators and the general public with the publication of a series of white papers in the journal, Investigative Ophthalmology & Visual Science.

Serge Resnikoff

In his editorial introducing the reports, Serge Resnikoff, MD, PhD, of the Brien Holden Vision Institute and School of Optometry and Vision Science, University of New South Wales, Sydney, New South Wales, Australia, said, “Myopia needed to be recognized as a public health issue if there was to be a change in the approach to this condition, and only a collaborative effort across all eye care professions and researchers could bring this about.”

The series of white papers focuses on defining and classifying myopia, potential interventions, clinical trials and instrumentation, industry guidelines and ethical considerations, clinical management guidelines, experimental models of emmetropization and myopia, and the genetics of myopia.

“These articles ... may form a basis for further research, bridging gaps and connecting people who so far had not intensively exchanged information and ideas,” Resnikoff said in his introduction.

Moving forward, the International Myopia Institute plans to foster scientific collaborations, help connect researchers and the public, and advocate for this issue among regulatory groups, he said.

Standardized terminology proposed

One group from the International Myopia Institute developed and proposed standards for definitions and thresholds to facilitate research into myopia prevention that leads to evidence-based medicine.

Ian Flitcroft, MA, DPhil, FRCOphth, said the new concept of pre-myopia is introduced in one of the white papers. It would apply to emmetropic children who are at high risk of developing myopia, he said.
Source: Ian Flitcroft, MA, DPhil, FRCOphth

They recommended that myopia terminology be limited to the following categories: myopia, secondary myopia, axial myopia and refractive myopia and, “as a quantitative trait,” that myopia be classified as all myopia, low myopia and high myopia.

High myopia was defined as a spherical equivalent refractive error of -6.00 D or less, and pathologic myopia was defined as the adverse, structural complications of myopia.

The group also defined “pre-myopia” as “a refractive state no more than +0.75 D and greater than -0.50 D “in children where a combination of baseline refraction, age and other quantifiable risk factors provide a sufficient likelihood of the future development of myopia to merit preventive interventions.”

Lead author of this report, Ian Flitcroft, MA, DPhil, FRCOphth, said the concept of pre-myopia will be new to many.

“This is a condition where children who are still emmetropic have features that indicate they have a high risk of developing myopia,” he told Primary Care Optometry News.

“Myopia develops fastest in young children and in the first years after onset,” he continued. “This means that early intervention will have the greatest impact on reducing the final amount of myopia. I believe pre-myopia will be a very useful clinical term to identify young children at risk to guide preventive strategies and to ensure that any interventions can be implemented at as young an age as possible.”

Monica Jong

Co-author Monica Jong, PhD, told PCON: “Previously myopia and high myopia have been defined many different ways, which has caused confusion amongst researchers and practitioners. The agreed-upon definitions in this white paper means that future research studies will allow better comparison, and practitioners and policy makers can also approach this ocular condition more systematically in their management.”

Flitcroft noted the importance of standardization for research, policy and medical practice.

“Improving our understanding and management of the complications of high myopia is also a critical area. An agreed set of definitions around the complications of this largely untreatable, yet sight-threatening condition, is an essential first step in developing interventions.”

No ‘one-size-fits-all’ approach

Experts from the International Myopia Institute who reviewed research on methods for controlling myopia progression concluded that no one treatment is completely effective in all patients.

They evaluated studies of interventions involving spectacles, contact lenses, pharmacology, outdoor influences and surgery.

Specifically, they considered research in: undercorrection with spectacle lenses, single vision peripheral defocus-correcting lenses, bifocal spectacle lenses, progressive-addition lenses, single vision soft contact lenses, gas permeables, soft multifocal contacts, orthokeratology, atropine, pirenzepine, 7-methylxanthine, timolol, time outdoors, vitamin D, indoor lighting, posterior scleral reinforcement, injection-based scleral strengthening, collagen cross-linking for scleral strengthening and combination therapies.

Lead author Christine Wildsoet, OD, PhD, FAAO, FARVO, told PCON that she and her team weighted evidence from randomized controlled trials most heavily in this review.

Among the many options available for slowing myopia progression, she said, “there appears to be no ‘one-size-fits-all’ among either optical or drug treatments, based on the variability in treatment effects reported in clinical trials. Perhaps this is not surprising, given the wide variety of behaviors exhibited by children, even within families, and differences in genetics, which likely influence myopia susceptibility.”

Topical atropine outperformed optical treatments despite unresolved questions, such as optimal dosing regimens, she said. “And the higher doses are not without significant ocular side effects, making optical treatments a more attractive starting option for many.”

Wildsoet noted that another pharmacological treatment, 7-methylxanthine, is available in a more “child friendly” oral formulation, but only in Denmark at this time.

“Studies examining the protective role of outdoor exposure have also yielded promising results in terms of myopia risk reduction, although the key factors underlying this protective effect remain elusive,” she told PCON. Surgical options “for stabilizing highly myopic eyes are lagging well behind treatments for slowing myopia progression and still largely limited to scleral buckling surgery.”

The need for urgent action “is helping to drive innovation in the area of intervention,” she said.

Wildsoet noted the interest in combination therapies, collagen cross-linking for highly myopic eyes and development of measurement instruments that will lead to the collection of better quality evidence.

“There is no better time for clinicians to fight myopia progression in their patients,” she concluded.

Clinicians must make educated decisions

Eye care providers treating children with myopia must be familiar with the issues surrounding controlling – or not controlling – the myopia and the potential long-term consequences.

In another report, the International Myopia Institute issued industry guidelines and ethical considerations for myopia control.

Lyndon Jones

Lead author Lyndon Jones, BSc, PhD, DSc, FCAHS, FCOptom, DipCLP, DipOrth, FAAO, FIACLE, FBCLA, told PCON, “The concept behind this was to think very carefully about the fact that whether it be clinicians, regulators or industry, we’re dealing with a vulnerable population.”

He noted that for clinicians, the primary issue is “ensuring that they understand why they are recommending, or not recommending, myopia control. In order to do that you need to be aware of the literature with regards to, first of all, what happens if you do nothing? If you allow the patient in your chair to not undergo some form of myopia management, and they’re a rapidly progressing myope, what are the potential long-term consequences?”

Previously, high myopia was considered an inconvenience due to the thick spectacles required for correction, Jones said.

The report refers to potential quality of life issues resulting from the use of vision correction for high prescriptions, such as introversion, anxiety, low self-esteem and less perceived attractiveness.

“But now we have really good epidemiological evidence that, certainly, once you get over -6.00 D, there’s a long-term risk of retinal detachment and myopic maculopathy that increases significantly,” Jones said. “It’s not even just those people over -6.00 D; even in people between -2.00 D and -6.00 D, for every diopter of myopia that occurs, your risk of long-term retinal disease increases.”

Another consideration is availability of evidence to support a myopia control strategy.

“They need to be up-to-date and cognizant of the literature about what’s available and also on-label vs. off-label,” Jones said. “Thirdly, what are the potential reductions in the progression of myopia that each of those procedures produce, and why would they choose one over the other?”

Clinicians must be aware of the risks and benefits of spectacles, soft contact lenses, orthokeratology and low-dose atropine, he said.

The authors of the report said the decision “represents the classical medical risk vs. benefit ratio.”

The belief that limiting myopia progression reduces the risk of vision-threatening disease is an “unverified premise,” and conclusive evidence will most likely not be available for decades.

However, if the assumption is proven correct, the benefits to society “could be substantial,” they said.

The authors noted the importance of clinicians providing appropriate informed consent for these off-label treatments and they provide a sample consent form in the appendix to the report.

Potential increased costs of treatment must be considered, they said, due to specialized equipment and extra clinic time.

Lastly, clinicians may be called upon to justify the professional rationale behind such treatments in the event of malpractice prosecution.

The authors provided five criteria for clinicians to consider when determining whether standards of practice are being met when prescribing off-label treatments: Is the drug or device approved? Has substantial peer review been conducted? Is it medically necessary? Is it nonexperimental? Has informed consent been provided, and has the patient agreed to it?

Jones concluded by saying that clinicians who are not comfortable using myopia control strategies should refer these children to someone who is.

Single vision specs not recommended for myopia progression

Options for controlling progressive myopia in children include the use of atropine, orthokeratology, multifocal soft contact lenses, and progressive-addition or bifocal spectacle lenses, but single vision spectacle lenses are not effective for this purpose, according to one of the other white papers.

“Although the efficacy over more than 5 years of myopia control treatment, plateau and rebound effects has not been established, current evidence still suggests that initiating some form of myopia control treatment is better than single vision correction,” the researchers said.)

  • The clinical management guidelines from the International Myopia Institute outline how clinicians can:
  • identify an appropriate patient for myopia control by evaluating risk factors;
  • discuss myopia control and risks with parents and patients;
  • discuss risks, benefits and expectations of treatments (including informed consent/off-label discussion);
  • perform a baseline exam;
  • select a treatment strategy; and
  • provide clinical care.
  • The report also details future treatment directions.

Author Kate Gifford, PhD, BAppSc(Optom)Hons, GCOT, FBCLA, FIACLE, FCCLSA, FAAO, told PCON that a dramatic increase in clinician awareness and product innovations by industry has recently matched findings that predict 50% of the world’s population will be myopic by 2050 (Holden et al.).

For this particular report, “The clear message for eye care providers is that it’s no longer best practice to simply prescribe single vision spectacles for progressing myopes when better options to control myopia are available,” she said in an interview with PCON. “Myopia management, at minimum, starts with a discussion on the consequences of myopia, risk factors and treatments – allowing parents and patients to make informed decisions that could influence lifelong eye health outcomes.

“The IMI white papers, and particularly these Clinical Management Guidelines, are designed to support ECPs through this imperative evolution of clinical practice,” she added. – by Nancy Hemphill, ELS, FAAO

Disclosures: Flitcroft, Jong and Wildsoet report no relevant financial disclosures. Gifford reports financial relationships with Alcon, CooperVision, Essilor, Menicon, Myopia Profile Pty. Ltd. and Visioneering Technologies. Jones reports financial relationships with Alcon, Allergan, Contamac, CooperVision, Essilor, GL Chemtec, Inflamax Research, Johnson & Johnson Vision, Menicon, Nature’s Way, Novartis, Ophtecs, PS Therapy, Safilens, Santen, Shire, SightGlass, TearLab, TearScience and Visioneering Technologies. Resnikoff is a consultant to the Brien Holden Vision Institute.

Members of the International Myopia Institute have taken the first step in making their research available to clinicians, governments, policy makers, educators and the general public with the publication of a series of white papers in the journal, Investigative Ophthalmology & Visual Science.

Serge Resnikoff

In his editorial introducing the reports, Serge Resnikoff, MD, PhD, of the Brien Holden Vision Institute and School of Optometry and Vision Science, University of New South Wales, Sydney, New South Wales, Australia, said, “Myopia needed to be recognized as a public health issue if there was to be a change in the approach to this condition, and only a collaborative effort across all eye care professions and researchers could bring this about.”

The series of white papers focuses on defining and classifying myopia, potential interventions, clinical trials and instrumentation, industry guidelines and ethical considerations, clinical management guidelines, experimental models of emmetropization and myopia, and the genetics of myopia.

“These articles ... may form a basis for further research, bridging gaps and connecting people who so far had not intensively exchanged information and ideas,” Resnikoff said in his introduction.

Moving forward, the International Myopia Institute plans to foster scientific collaborations, help connect researchers and the public, and advocate for this issue among regulatory groups, he said.

Standardized terminology proposed

One group from the International Myopia Institute developed and proposed standards for definitions and thresholds to facilitate research into myopia prevention that leads to evidence-based medicine.

Ian Flitcroft, MA, DPhil, FRCOphth, said the new concept of pre-myopia is introduced in one of the white papers. It would apply to emmetropic children who are at high risk of developing myopia, he said.
Source: Ian Flitcroft, MA, DPhil, FRCOphth

They recommended that myopia terminology be limited to the following categories: myopia, secondary myopia, axial myopia and refractive myopia and, “as a quantitative trait,” that myopia be classified as all myopia, low myopia and high myopia.

High myopia was defined as a spherical equivalent refractive error of -6.00 D or less, and pathologic myopia was defined as the adverse, structural complications of myopia.

The group also defined “pre-myopia” as “a refractive state no more than +0.75 D and greater than -0.50 D “in children where a combination of baseline refraction, age and other quantifiable risk factors provide a sufficient likelihood of the future development of myopia to merit preventive interventions.”

Lead author of this report, Ian Flitcroft, MA, DPhil, FRCOphth, said the concept of pre-myopia will be new to many.

PAGE BREAK

“This is a condition where children who are still emmetropic have features that indicate they have a high risk of developing myopia,” he told Primary Care Optometry News.

“Myopia develops fastest in young children and in the first years after onset,” he continued. “This means that early intervention will have the greatest impact on reducing the final amount of myopia. I believe pre-myopia will be a very useful clinical term to identify young children at risk to guide preventive strategies and to ensure that any interventions can be implemented at as young an age as possible.”

Monica Jong

Co-author Monica Jong, PhD, told PCON: “Previously myopia and high myopia have been defined many different ways, which has caused confusion amongst researchers and practitioners. The agreed-upon definitions in this white paper means that future research studies will allow better comparison, and practitioners and policy makers can also approach this ocular condition more systematically in their management.”

Flitcroft noted the importance of standardization for research, policy and medical practice.

“Improving our understanding and management of the complications of high myopia is also a critical area. An agreed set of definitions around the complications of this largely untreatable, yet sight-threatening condition, is an essential first step in developing interventions.”

No ‘one-size-fits-all’ approach

Experts from the International Myopia Institute who reviewed research on methods for controlling myopia progression concluded that no one treatment is completely effective in all patients.

They evaluated studies of interventions involving spectacles, contact lenses, pharmacology, outdoor influences and surgery.

Specifically, they considered research in: undercorrection with spectacle lenses, single vision peripheral defocus-correcting lenses, bifocal spectacle lenses, progressive-addition lenses, single vision soft contact lenses, gas permeables, soft multifocal contacts, orthokeratology, atropine, pirenzepine, 7-methylxanthine, timolol, time outdoors, vitamin D, indoor lighting, posterior scleral reinforcement, injection-based scleral strengthening, collagen cross-linking for scleral strengthening and combination therapies.

Lead author Christine Wildsoet, OD, PhD, FAAO, FARVO, told PCON that she and her team weighted evidence from randomized controlled trials most heavily in this review.

Among the many options available for slowing myopia progression, she said, “there appears to be no ‘one-size-fits-all’ among either optical or drug treatments, based on the variability in treatment effects reported in clinical trials. Perhaps this is not surprising, given the wide variety of behaviors exhibited by children, even within families, and differences in genetics, which likely influence myopia susceptibility.”

Topical atropine outperformed optical treatments despite unresolved questions, such as optimal dosing regimens, she said. “And the higher doses are not without significant ocular side effects, making optical treatments a more attractive starting option for many.”

PAGE BREAK

Wildsoet noted that another pharmacological treatment, 7-methylxanthine, is available in a more “child friendly” oral formulation, but only in Denmark at this time.

“Studies examining the protective role of outdoor exposure have also yielded promising results in terms of myopia risk reduction, although the key factors underlying this protective effect remain elusive,” she told PCON. Surgical options “for stabilizing highly myopic eyes are lagging well behind treatments for slowing myopia progression and still largely limited to scleral buckling surgery.”

The need for urgent action “is helping to drive innovation in the area of intervention,” she said.

Wildsoet noted the interest in combination therapies, collagen cross-linking for highly myopic eyes and development of measurement instruments that will lead to the collection of better quality evidence.

“There is no better time for clinicians to fight myopia progression in their patients,” she concluded.

Clinicians must make educated decisions

Eye care providers treating children with myopia must be familiar with the issues surrounding controlling – or not controlling – the myopia and the potential long-term consequences.

In another report, the International Myopia Institute issued industry guidelines and ethical considerations for myopia control.

Lyndon Jones

Lead author Lyndon Jones, BSc, PhD, DSc, FCAHS, FCOptom, DipCLP, DipOrth, FAAO, FIACLE, FBCLA, told PCON, “The concept behind this was to think very carefully about the fact that whether it be clinicians, regulators or industry, we’re dealing with a vulnerable population.”

He noted that for clinicians, the primary issue is “ensuring that they understand why they are recommending, or not recommending, myopia control. In order to do that you need to be aware of the literature with regards to, first of all, what happens if you do nothing? If you allow the patient in your chair to not undergo some form of myopia management, and they’re a rapidly progressing myope, what are the potential long-term consequences?”

Previously, high myopia was considered an inconvenience due to the thick spectacles required for correction, Jones said.

The report refers to potential quality of life issues resulting from the use of vision correction for high prescriptions, such as introversion, anxiety, low self-esteem and less perceived attractiveness.

“But now we have really good epidemiological evidence that, certainly, once you get over -6.00 D, there’s a long-term risk of retinal detachment and myopic maculopathy that increases significantly,” Jones said. “It’s not even just those people over -6.00 D; even in people between -2.00 D and -6.00 D, for every diopter of myopia that occurs, your risk of long-term retinal disease increases.”

PAGE BREAK

Another consideration is availability of evidence to support a myopia control strategy.

“They need to be up-to-date and cognizant of the literature about what’s available and also on-label vs. off-label,” Jones said. “Thirdly, what are the potential reductions in the progression of myopia that each of those procedures produce, and why would they choose one over the other?”

Clinicians must be aware of the risks and benefits of spectacles, soft contact lenses, orthokeratology and low-dose atropine, he said.

The authors of the report said the decision “represents the classical medical risk vs. benefit ratio.”

The belief that limiting myopia progression reduces the risk of vision-threatening disease is an “unverified premise,” and conclusive evidence will most likely not be available for decades.

However, if the assumption is proven correct, the benefits to society “could be substantial,” they said.

The authors noted the importance of clinicians providing appropriate informed consent for these off-label treatments and they provide a sample consent form in the appendix to the report.

Potential increased costs of treatment must be considered, they said, due to specialized equipment and extra clinic time.

Lastly, clinicians may be called upon to justify the professional rationale behind such treatments in the event of malpractice prosecution.

The authors provided five criteria for clinicians to consider when determining whether standards of practice are being met when prescribing off-label treatments: Is the drug or device approved? Has substantial peer review been conducted? Is it medically necessary? Is it nonexperimental? Has informed consent been provided, and has the patient agreed to it?

Jones concluded by saying that clinicians who are not comfortable using myopia control strategies should refer these children to someone who is.

Single vision specs not recommended for myopia progression

Options for controlling progressive myopia in children include the use of atropine, orthokeratology, multifocal soft contact lenses, and progressive-addition or bifocal spectacle lenses, but single vision spectacle lenses are not effective for this purpose, according to one of the other white papers.

“Although the efficacy over more than 5 years of myopia control treatment, plateau and rebound effects has not been established, current evidence still suggests that initiating some form of myopia control treatment is better than single vision correction,” the researchers said.)

  • The clinical management guidelines from the International Myopia Institute outline how clinicians can:
  • identify an appropriate patient for myopia control by evaluating risk factors;
  • discuss myopia control and risks with parents and patients;
  • discuss risks, benefits and expectations of treatments (including informed consent/off-label discussion);
  • perform a baseline exam;
  • select a treatment strategy; and
  • provide clinical care.
  • The report also details future treatment directions.

Author Kate Gifford, PhD, BAppSc(Optom)Hons, GCOT, FBCLA, FIACLE, FCCLSA, FAAO, told PCON that a dramatic increase in clinician awareness and product innovations by industry has recently matched findings that predict 50% of the world’s population will be myopic by 2050 (Holden et al.).

For this particular report, “The clear message for eye care providers is that it’s no longer best practice to simply prescribe single vision spectacles for progressing myopes when better options to control myopia are available,” she said in an interview with PCON. “Myopia management, at minimum, starts with a discussion on the consequences of myopia, risk factors and treatments – allowing parents and patients to make informed decisions that could influence lifelong eye health outcomes.

“The IMI white papers, and particularly these Clinical Management Guidelines, are designed to support ECPs through this imperative evolution of clinical practice,” she added. – by Nancy Hemphill, ELS, FAAO

Disclosures: Flitcroft, Jong and Wildsoet report no relevant financial disclosures. Gifford reports financial relationships with Alcon, CooperVision, Essilor, Menicon, Myopia Profile Pty. Ltd. and Visioneering Technologies. Jones reports financial relationships with Alcon, Allergan, Contamac, CooperVision, Essilor, GL Chemtec, Inflamax Research, Johnson & Johnson Vision, Menicon, Nature’s Way, Novartis, Ophtecs, PS Therapy, Safilens, Santen, Shire, SightGlass, TearLab, TearScience and Visioneering Technologies. Resnikoff is a consultant to the Brien Holden Vision Institute.