🏛️ Verified NIH Record • Updated 2024-08-30

Phase III Presbyopia Correction Using the VIS Opti-K™ System (NCT06487897)

Phase III Presbyopia Correction Using the VIS Optimal Keratoplasty (Opti-K™) System (Phase IIIa)

🟢 Recruiting Phase3 ⚙️ Medical Device Protocol Sponsor: VIS, Inc.

🩺 Plain-English Summary (8th-Grade Level)

The goal of this clinical trial is to evaluate the safety and efficacy of using the VIS Opti-K System to enable monovision by providing temporary improvement in near vision through the treatment of the non-dominant eye of low myopic, emmetropic and low hyperopic presbyope subjects. The main questions it aims to answer are determining uncorrected near visual acuity at 40cm in the treated eye and subjective improvement as measured by the patient satisfaction questionnaire.

Who can join: Review the eligibility criteria below.

Location: Cohen Laser & Vision Center — Boca Raton, Florida

Age range: 40 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (4 Sites)

  • Cohen Laser & Vision Center — Boca Raton, Florida
  • Claris Vision Eye Health — South Dartmouth, Massachusetts
  • The Cornea & Laser Eye Institute — Teaneck, New Jersey
  • OCLI Vision - Oceanside — Oceanside, New York

📞 Contact the Study Coordinator

Phone: (214) 855-1222

Email: kwort@totalcro.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Presbyopia clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗