Cataract & Refractive Conditions
Leading Cataracts & Refractive clinical research development through precision trial design, optimized enrollment, and a continuous learning loop from decades of experience.
Evolving research to meet evolving patient needs.
Cataracts & Refractive Conditions are major causes of vision impairment, affecting hundreds of millions of patients worldwide. While surgery and corrective lenses offer relief, they don’t address underlying causes or evolving patient needs. The demand for more precise, accessible treatments is accelerating innovation in the Cataract & Refractive landscape.
With over a decade of focused experience in Cataract & Refractive research, Ora has led over 60+ programs in this space—across all phases—in the past five years alone. Our success is built on precision trial design, optimized enrollment, global site access, and a continuous learning loop from decades of development. Working together as a team, we’ll deliver a clear, strategic path to approval.
Team up with Ora, the ophthalmology research company to provide your next generation Cataract & Refractive Conditions therapeutic or device the edge it needs to win the race to market approval.
Key Indications
Cataracts
Myopia
Presbyopia
The Ora Cataract & Refractive Condition Team Leaders
Keith Lane
Senior Vice President, Posterior Segment
10+ years in refractive disease pharmaceutical development
Expert in innovative ophthalmic disease endpoints and complex trial design
Published leader in retinal research and FDA-accepted mobility tests
Dr. Gus De Moraes
MD, PhD, MPH, FARVO – Chief Medical Officer
World-renowned ophthalmologist, ranked top 10 glaucoma specialists worldwide based on his research
15+ years of experience leading clinical trials and research
Co-directs medical safety and pharmacovigilance team
Oversees protocol design, recruitment strategies, and endpoint determination
Caitlin Black
Vice President Clinical Operations, Anterior Segment & Medical Devices
17 years’ experience in Ophthalmology as a clinician and clinical researcher
Leader in Anterior and Medical Device trials, overseeing global clinical strategy and operations
Expert in clinical development and regulatory strategy, with a background in Orthoptics and clinical research
Ora Cataract & Refractive Condition experience over the last 5 years
Patients enrolled
Sites activated
Programs
The Ora Cataract & Refractive Condition team’s comprehensive expertise spans early-phase studies to late-stage clinical trials. Our strategic regulatory guidance and efficient operational execution, ensures seamless trial progression through even the most complex development pathways.
Why sponsors with therapies in the Cataract & Refractive Conditions pipeline choose to partner with Ora:
A sample of Ora successes
Expert end-to-end Cataract & Refractive Condition therapeutic pipeline highlights:
Proven ability to accelerate enrollment in a recent global pediatric myopia study that enrolled 675+ patients across eight countries in two years.
From phase 1 to submission partnership for recently submitted FDA presbyopic therapeutic eye drop, including randomization of 1,000+ subjects across 3 studies.
Enrollment of 50+ subjects per month across recent IOL study including over 40 sites and over 500 subjects.
Ask us about our turnkey solution for IOL and diagnostic ophthalmology device trials.
The Ora difference in a Cataract & Refractive Condition clinical trial
Global Pediatric Myopia Progression Study
Teamwork Drove a Successful Start
Ora has local teams around the world with the ophthalmology experience sponsors need for successful product development. Regional and in-country Ora clinical ophthalmology experts with expansive experience understand and adapt to local nuances, ensuring regulatory, investigator, and patient success on the ground from day one through the completion of any global study.
At Ora, we go above and beyond what a typical CRO will do for their partners to ensure a successful study. We put you and your study subjects first.
Key Pediatric Myopia Study Success Factors
Cascading communication between countries
In the pediatric myopia study, enrollment started in the US, then in the UK and Europe and finished in China. Open communication between the different Ora site teams allowed for the enrollment process to be improved and optimized as the study progressed to achieve enrollment on time.
Global-to-local approach
Ora will never use a “one size fits all” model. In the pediatric myopia study, we tailored our overarching strategies, frameworks, and systems to specific global communities. Thus, ensuring that Ora’s high-level goals and strategies were effectively molded to meet the specific needs of different countries, communities, and cultures.
Customized patient recruitment
Ora’s in house marketing team worked with the pediatric myopia study team to craft customized recruitment materials (brochures, videos, social media advertisements, etc.) centered around educating/putting parents and their children at ease about joining the clinical trial.
Further study expansion to meet clinical trial criteria
Ora actively expanded the pediatric myopia trial to include Poland and Hungary to ensure 30% of the enrolled study subjects had light eyes (blue or green). Our extensive global site network allowed us to make this addition seamlessly.
Global Operations Success Factors
KOLs Ophthalmic Networks and Site Selection
Focused Site and Patient Engagement
“One Team” Mentality with Sponsor
Risk/Issue Identification Mitigation and Escalations
Study Details
- 678 patients
- 48 sites
Global Reach
- 8 countries
- 3 continents
China, Hungry, Poland, Ireland, Slovakia, Spain, United Kingdom, United States
