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IC-8 Apthera IOL New Enrollment Post Approval Study

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Study sites: 12 to 14v9
  2. Lead sponsor: AcuFocus, Inc. to Bausch & Lomb Incorporatedv8
  3. Re-verified, no change to tracked fieldsv7
  4. Study sites: 13 to 12v6
  5. Study sites: 12 to 13v5
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  1. Study sites: 11 to 12v4
  2. Site details revised at 4 of 11 sitesv3
  3. Study sites revised (11)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to verify the post-market safety of the IC-8 Apthera IOL after the treatment of posterior capsular opacification (PCO), an expected complication related to IC-8 Apthera IOL implantation.
Trial Details
NCT Number NCT06060041
Lead Sponsor Bausch & Lomb Incorporated
Conditions
(from sponsor)		 Cataract, Presbyopia, Posterior Capsule Opacification
Related terms Cataract, Presbyopia
Enrollment 435 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov