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Post Event Review & Minutes for CCOI Paris Hybrid Workshop｜8th September 2025

Video Recordings


PART 1 OVERVIEW

  • Valerie opened CCOI's first international myopia workshop in Paris, highlighting global participation with 41 online attendees from seven continents, emphasizing the mission to eliminate barriers between innovations and patients.

  • Professor Tian Ying Wong reported that myopia now affects billions worldwide, with significant rates increasing in traditionally lower-risk populations due to rising education levels.

  • Myopia's economic impact was quantified at $250 billion in lost productivity as of 2015, underscoring the urgency of addressing this growing problem.

  • Professor Coutier revealed that 42% of high myopes progressed to atrophic maculopathy over four years, with macular posterior staphyloma presenting a 3.9x higher risk.

  • Data from the SCOM Singapore cohort showed that myopia rates increase from 28% at age 7 to 43% at age 9, indicating a critical window for intervention.

  • Outdoor time was noted as effective for myopia prevention but not for slowing progression, while low-dose atropine demonstrated a dose-dependent response in mitigating myopia’s effects.

  • Highly aspherical lenslet (HAL) spectacles were shown to have a 55-67% efficacy rate in reducing myopia progression with significant child adaptation.

  • MiSight is currently the only FDA-approved contact lens for myopia control, with combination therapies offering additional benefits in axial length reduction.

  • Regulatory challenges persist, with only MiSight cleared for myopia control and no devices approved for myopia screening despite existing diagnostic aids.

 

Notes

Opening and Introduction (00:26 - 14:53)

  • Valerie opened CCOI's first international in-person myopia workshop in Paris, highlighting global participation with 41 online attendees from seven continents.

  • CCOI mission emphasized: eliminate roadblocks between ophthalmic innovations and patients, focusing on myopia progression and harmonized clinical trials.

  • Professor Audre Coutier and French Myopia Institute acknowledged as generous hosts for the Paris venue.

 

Epidemiology and Natural Progression Session (18:39 - 22:20)

  • Professor Tian Ying Wong presented myopia definitions and epidemiology, noting myopia affects billions globally with increasing rates in traditionally lower-risk populations.

  • Myopia progression linked strongly to education levels - grades 10-12 vs grades 1-3 show significant differences in urban and rural populations.

  • Economic impact quantified: uncorrected myopia costs $250 billion in lost global productivity in 2015.

 

Myopia-Related Complications (28:47 - 32:54)

  • Professor Coutier detailed myopic maculopathy using ATN classification: atrophic, tractional, and neovascular components affecting 2/3 of high myopes.

  • Spanish study of 800+ eyes over 4 years showed 42% progression in atrophic maculopathy, with macular posterior staphyloma providing 3.9x higher risk.

  • Italian cohort of 1,228 eyes with 11-year follow-up revealed 57% atrophic progression, emphasizing staphyloma location over axial length alone.

 

Mechanisms of Axial Elongation (39:17 - 42:38)

  • Professor Seong Mei presented SCOM Singapore cohort data showing myopia rates: 28% at age 7, 43% at age 9, with more rapid elongation before and after myopia onset.

  • Risk factors identified: excessive near work (books read per week), insufficient outdoor time, and genetic predisposition through parental myopia.

  • Dopamine mechanism explained: outdoor light exposure releases retinal dopamine, thickening choroid and preventing scleral remodeling.

 

Natural Progression Rates (49:44 - 55:41)

  • Professor Ian Morgan distinguished between myopia progression terminology, noting 7-year-olds progress at -0.2 diopters/year (hyperopic) vs -1.2 diopters/year (myopic).

  • Age of onset critical: child myopic at age 6 progresses ~7 diopters by age 16 (high myopia), while onset at age 12 results in only 1.5 diopters progression.

  • East Asian children show consistently higher progression rates than Western counterparts across multiple studies.

 

Treatment Modalities Session (01:12:34 - 01:19:11)

  • Professor Marcus Ang categorized interventions: environmental (outdoor time), optical (spectacles/contact lenses), and pharmacological (low-dose atropine).

  • Outdoor time effective for prevention but poor for slowing progression; orthokeratology carries microbial keratitis risk in pediatric populations.

  • Multiple meta-analyses show dose-dependent atropine response with minimal side effects at low concentrations.

 

Spectacle Lens Innovations (01:25:16 - 01:28:57)

  • Olga Pranat presented highly aspherical lenslet (HAL) spectacles with 90% child adaptation within 3 days, 100% within one week.

  • HAL two-year trial showed 55-67% efficacy for spherical equivalent, 51-60% for axial length with full-time wear >12 hours/day.

  • Six-year data revealed 1.95 diopter reduction and 0.81mm axial elongation slowing, with only 9% developing high myopia vs 38% in control group.

️ 

Contact Lens Approaches (01:32:10 - 01:39:17)

  • Professor Jeffrey Walline emphasized center-distance soft multifocal designs, with MiSight being the only FDA-approved myopia control modality.

  • Combination therapy (0.01% atropine + orthokeratology or soft multifocals) provides additional 0.1mm axial length benefit over monotherapy.

  • Contact lens safety data shows no increased risk for children 6-12 years vs adults, with 21% reporting painful red eye over 10+ years.

 

Industry and Regulatory Perspectives (01:42:18 - 01:50:19)

  • Norbert Gorney highlighted optical industry investment over four decades, calling for harmonized device/drug endpoints and risk-based approaches.

  • Point spread function analysis revealed efficacious lenses create local spatial contrast changes, decoded by specific retinal ganglion cells.

  • Clinical trial challenges include cohort availability, study duration costs, and parental reluctance for placebo groups.

 

Regulatory Framework Discussion (02:12:11 - 02:12:58)

  • Paula Johns from FDA discussed regulatory challenges, noting only MiSight contact lens currently FDA-approved for myopia control.

  • No FDA-cleared devices for myopia screening exist, despite many cleared diagnostic aids.

  • 2003 FDA advisory panel and 2016 workshop addressed study populations and trial design for myopia control products.

 

Panel Discussion Insights (01:53:28 - 02:04:24)

  • Risk-based approach advocated for clinical trials, with proportional effect measures preferred over fixed thresholds.

  • AI and digital twins identified as key accelerators for clinical development and patient identification in underserved areas.

  • Compliance strategies emphasized through proper communication, with Chinese HAL trial achieving 93% compliance averaging >13 hours daily wear.

Part 1 Action Items

CCOI Myopia Work Group

  • Develop large, diverse, high-quality datasets to feed AI development and clinical research (02:11:23)

  • Create consensus on clinical trials and endpoints for myopia control technologies (02:11:23)

 

European Union/Healthcare Systems

  • Implement outdoor time programs in European school systems similar to successful Asian models (01:01:08)

  • Develop myopia screening and follow-up protocols for high-risk patients at certain axial lengths (01:07:06)

 

Research Community

  • Collect DNA samples from children in myopia control trials for future meta-analyses (01:02:31)

  • Establish harmonized device and drug endpoints for myopia control products globally (01:48:59)

Part 2 Overview


  • PMDA Japan categorized myopia control devices into three groups, highlighting MySite lens approval with overseas data showing 0.64 diopter reduction compared to 0.79 in Japan.

  • Timo Kratzer emphasized the need for standards harmonization for global market access, referencing ISO 13485 requirements and upcoming development of myopia-specific standards.

  • Singapore HSA classified myopia control contact lenses as Class B medical devices and outlined regulatory requirements for combination products based on primary action mode.

  • US FDA requires class-based submissions with devices needing pivotal trials while drugs require two well-controlled trials, leading to regulatory inconsistency across jurisdictions.

  • Mark Bullimore criticized historical controls for recruitment biases and proposed using a 15% annual axial elongation model for ethical trial designs.

  • Ian Flitcroft advocated for evidence-based metrics in effectiveness measurement, drawing on data from over 160,000 subjects to enhance prediction accuracy for axial length changes.

  • Myopia control spectacles face greater assessment burdens despite their lower risk status, necessitating simplified assessment measures to streamline processes.

  • Emerging consensus on a minimum study duration of 2-3 years was noted, with ethical concerns about delaying treatment for myopic children emphasized, particularly in high-risk populations.

  • Panel discussions supported a one-year effectiveness threshold with 0.1mm axial length slowing as sufficient evidence, highlighting predictive model utility for long-term outcomes.

  • Recommendations included post-market surveillance to monitor treatment rebound effects rather than extended


NOTES

Regulatory Framework Overview (00:16 - 06:12)

  • PMDA Japan presented myopia control device categorization: new medical devices (require clinical evaluation), improved medical devices (some need clinical trials), and generic medical devices (usually no new trials needed)

  • MySite contact lens approval highlighted as example of overseas clinical trial data acceptance, showing 0.64 diopter reduction overseas vs 0.79 in Japan, with similar axial length increases (0.23mm overseas, 0.34mm Japan)

  • Standards harmonization emphasized by Timo Kratzer as essential for global market access, noting ISO 13485 medical device quality management requirements and upcoming myopia-specific standards development.

International Regulatory Perspectives (18:31 - 30:31)

  • Singapore HSA outlined regulatory pathways: contact lenses for myopia control classified as medical devices (Class B if overnight use), atropine drops as pharmaceutical products, combination products regulated based on primary mode of action.

  • US FDA requires class-based submissions (Class 1-3 based on risk), with devices needing 1-3 pivotal trials vs drugs requiring 2 well-controlled trials for effectiveness demonstration.

  • Combination products regulated by primary mode of action across all jurisdictions, with formal designation request processes available through FDA's Office of Combination Products.

Clinical Trial Design Standards (57:24 - 01:04:30)

  • Historical controls deemed inappropriate by Mark Bullimore due to recruitment biases, availability of treatments, and cohort differences - recommends extrapolated control groups using 15% annual axial elongation slowing model.

  • Time-to-treatment failure approach proposed as ethical alternative using survival analysis, allowing children progressing beyond specified criteria to exit trial and receive rescue treatment after one year.

  • FDA effectiveness criteria currently differ between devices (mean progression over 2-3 years) and drugs (proportion progressing by ≥0.5 diopter), creating inconsistent regulatory landscape.

Effectiveness Measurement Framework (01:11:36 - 01:15:12)

  • Evidence-based metrics advocated by Ian Flitcroft including baseline refraction, axial length, age, and ethnicity adjustments, with centile models from 160,000+ subjects across 9 countries providing prediction accuracy <0.1mm or 0.1 diopter.

  • Patient-focused outcomes prioritizing uncorrected visual acuity maintenance (keeping >20/60), glass thickness stability, and laser surgery candidacy preservation over purely clinical metrics.

  • Long-term health modeling demonstrating 1 diopter myopia equals ~2 years aging effect on visual impairment risk, with treatment potentially adding 4.4 years of good vision quality.

️ Safety Assessment Requirements (01:20:15 - 01:26:38)

  • Myopia control spectacles require milestone development assessment, physical safety demonstration, functional vision comparison to single vision lenses, and adverse event categorization despite being lowest-risk devices.

  • Disproportionate burden identified for spectacles vs contact lenses/drugs, with complex obstacle courses and reading comprehension tests required only for spectacles despite minimal visual disruption.

  • Simplified assessment recommendations including emoticon-based quality of life questionnaires, basic visual acuity/stereo acuity testing, and parent/child fall assessment questionnaires rather than complex physical demonstrations.

  • ⏳ Study Duration and Rebound Considerations (01:30:53 - 01:38:09)

  • Minimum study duration consensus emerging around 2-3 years, with recognition that first-year effectiveness typically highest but treatment effects continuing at modest levels in subsequent years.

  • Ethical concerns raised about withholding treatment from myopic children for 3+ years given established association with uncorrectable visual impairment, particularly in fast-progressing East Asian populations.

  • Rebound evidence limited to pharmacological treatments (particularly atropine), with no scientific evidence of rebound in optical treatments, suggesting post-market surveillance may be more appropriate than extended control periods.

Panel Discussion Consensus Points (02:15:19 - 02:29:41)

  • One-year effectiveness threshold supported by multiple panelists with 0.1mm axial length slowing considered adequate evidence, leveraging predictive models for longer-term efficacy extrapolation.

  • Risk-benefit calibration acknowledged need for higher effectiveness thresholds for higher-risk devices, but emphasized clinical significance requirements regardless of risk profile.

  • Post-market surveillance recommended for rebound monitoring rather than extended clinical trials, particularly for optical treatments with established safety profiles.

ACTION ITEMS

CCOI Team

  • Schedule two additional workshops focusing on pharmacological treatments, light therapy, and AI-related myopia control products - finalize dates for completion before December next year (02:31:27)

  • Summarize workshop discussions and distribute to all participants and additional stakeholders for consensus building (02:31:27)

  • Develop AI-enabled Delphi process to accelerate consensus building, potentially reducing typical multi-month timeline for consensus papers (02:32:48)

  • Create data registries for different global regions to support evidence collection and standardization efforts (02:31:27)

Regulatory Bodies (Collective)

  • Harmonize effectiveness endpoints across medical products for same intended use, addressing current inconsistencies between device and drug approval criteria (01:04:30)

  • Consider risk-benefit calibration for effectiveness thresholds, allowing lower thresholds for lower-risk devices like spectacles (02:25:22)

Standards Organizations

  • Develop myopia-specific clinical trial standards to replace current product design standards that lack global acceptance (33:49)

  • Create global standards framework that meets regulatory requirements across multiple jurisdictions to reduce market access barriers (35:07)