7:30 - 7:55 Registration & Breakfast
7:55 - 8:00 Welcome
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Michael X. Repka, MD, MBA |
8:00 - 8:30 Opening Presentation
8:00 - 8:15 - Age as a Barrier: The ongoing Evolution of IOL Indications, What We’ve Achieved and What’s Next | Malvina Eydelman, MD  |
8:15 - 8:30 - Why Pursue On-label IOLs for the Pediatric Population: The Clinical Importance of approval | M. Edward Wilson, MD |
8:30 - 10:20 - Session 1
Current Marketing Framework and How to Bridge the Gap
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8:30 - 8:40 - Regulatory History of IOLs Bennett Walker, PhD |
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8:40 - 8:50 - Bridging Adult Standards and Modifications to incorporate Pediatric cases Don Calogero, MSE |
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8:50 - 9:00 - Defining a Pediatric IOL Patient, Who, When, & What Michael X. Repka, MD, MBA |
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9:00 - 9:10 - Appropriate Age Brackets, Anatomical Differences, Eye Growth Considerations for Pediatric IOL Marie-José Tassignon, MD, PhD |
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9:10 - 9:20 - Bridging the Gap Between Existing Regulatory Framework and What’s Known About Pediatrics Patients Aisha Traish, MD |
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9:20 - 9:30 - Historical Data & Control Arms: What’s a Valid Comparator in Pediatrics? Aracelis Torres, PhD, MPH |
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9:30 - 9:40 - What Data Do We Need Scott Lambert, MD |
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9:40 - 9:50 - Impact of Laterality on VA and IOP Outcomes Deborah VanderVeen, MD |
Panelist:
- Bennett Walker, PhD
- Don Calogero, MSE
- Marie-José Tassignon, MD, PhD
- Aisha Traish, MD
- M. Edward Wilson, MD
- Scott Lambert, MD
- Michael X. Repka, MD, MBA
- Aracelis Torres, PhD
- Deborah VanderVeen, MD
10:20-10:40 - Morning Break
10:40 - 11:45 - Session 2
Stakeholder Perspectives and Ethical Considerations
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10:40 - 10:50 - How Long of Follow-up is Necessary Scott Lambert, MD |
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10:50 - 11:00 -Challenges of Small Clinical Markets and Long-term Trials Moderator: Samuel Masket, MD Panelist: To be determined |
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11:00 - 11:10 - Practical Expectations from Pediatric Eye Surgeons Michael X. Repka, MD, MBA |
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11:10 - 11:45 - Industry Panel Discussion Moderator: Malvina Eydelman, MD Panelist: Jim Ellis, MD (President/CEO JelliSee Ophthalmics) |
11:45 - 12:20 - Lunch Break
Future of Ophthalmology Round Table
Ophthalmology Residents and Pediatric Fellows invited to join roundtable discussion
12:20 - 14:15 - Session 3
Current Data
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12:20 - 12:40 - Status of IOL Implantation in Children in USA Panelist:
12:40 - 12:50 - Pediatric IOL Implantation in India Ramesh Kekunnaya, MD 12:50 - 13:00 - Pediatric IOL Implantation in Brazil Bruna Ventura, MD, PhD 13:00-13:10 - Pediatric IOL Implantation in China Weirong Chen, MD 13:10-13:20 - Pediatric IOL Implantation in Europe Darius Hildebrand MD 13:20-13:30 - Real World Data, Real World Evidence Ken Nischal, MD 13:30-13:45 - Challenges with Utilizing Data Between Different Studies Vicki Chen, MD 13:45 - 14:15 - Panel Discussion Panelist:
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14:15 - 14:45 - Session 4
Defining a Path Forward: Aligning FDA, ISO, and Clinical Realities
Optimizing the FDA Regulatory Pathway for a Small-Volume Product
Panelist:
- Aisha Traish, MD
- Bennett Walker, PhD
- Samuel Masket, MD
14:45 - 15:00 Closing Remarks
Key Takeaways and Action Items
Natalie Afshari, MD, Malvina Eydelman, MD