Clinical Studies

LENTICULAR RESEARCH GROUP, LLC

CLINICAL STUDY ACTION PLAN:  ANIMAL & HUMAN

Cadaver Lens Study 2014 – 2017

  1. Reconfigure MPM – Design Process
  • Goal – Redesign MPM imaging unit for Live Animal and Human use.   Completed
  • Build prototype, Develop calibration technique and performance specifications, Test and refine system.  Completed
  • Contract with GLP (Good Laboratory Practice) lab for Live Animal Study (Rabbit).  Completed
  1. Live Animal Study
  • Goal – Lazar Targets (Spots) can be accurately and consistently delivered within 2-5 microns below the lens capsule
  • Imaging system is robust and allows for the visualization of the anterior lens epithelium

Target Achievements: Proof of Concept ‘Target & Alter Growth of Germinative Cells in Live Rabbits’

  • The targeted lens epithelial cells are no longer viable
  • Boundary condition testing to evaluate collateral effects are satisfactory
  • Target 40 Rabbit eye treatments – Estimate 3 Month Lab time
  • Capture pre, intra & post op images 
  • Develop live lens treatment algorithm & file additional patents accordingly
  • System operation – unit is functional and calibrates within specification

III. Early Human Trials

  • Goal – Demonstrate ability to maintain accommodative capability
  • Pre-Clinical:
  • Contract with clinic in Dominican Republic, Venezuela or Costa Rica for pre-clinical work
  • Ship, assemble, test prototype & gain required local approvals
  • Perform a series of pre-clinical trials; estimated subjects 10 (intended for presbyopic surgery) to refine and test system

       Target Achievements:

  • System operation – unit is functional and calibrates within specifications
  • Safety – Beat FDA Best Corrected Visual Acuity (BCVA) study target (<1% lose 2 lines BCVA)
  • No cataract formation, no retinal changes observed for 3 months post treatment
  • Able to visualize the retina without difficulty, no inflammatory changes anterior or posterior segments
  • Efficacy – spot pattern is accurate and consistent
  • No additional loss of accommodation through 1 or 3 months of follow up
  1. Perform Ethics Approved EU Clinical Trial
  • Obtain ethics approval to treat 50 subjects at one or two EU sites
  • Randomized contralateral eye study in early Presbyopes (one eye treated and one eye as control)

Study Goals: Proof of Concept ‘Target & Halt growth of Germinative Cells in Humans’

  • Safety – Exceed FDA BCVA target (<1% lose 2 lines BCVA)
  • No cataract formation through 6 months of follow up
  • Able to visualize the retina without difficulty
  • Efficacy – spot pattern is accurate and consistent
  • No additional loss of accommodation through 9 months of follow up when compared to fellow untreated eye
  • Receive CE Mark to initiate commercialization