Refocus VisAbility™ Micro Insert System Pre-market Clinical Trial
Recruiting
N/A
Interventional Study
Presbyopia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 45 – 60
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 33 (estimated)
- Sponsor
- Refocus Group, Inc. · Industry
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About This Trial
The primary study objective is to evaluate the safety and effectiveness of the VisAbility™ Micro Insert System for improvement in binocular distance corrected near visual acuity in presbyopic patients.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Subjects must be between ages of 45 to 60 at the time of enrolment.
2. Subjects must have best corrected distance visual acuity (BCDVA) of 20/20 in each eye.
3. Subjects must have distance corrected near visual acuity (DCNVA) @ 40 cm of 20/50, 20/63 or 20/80 in each eye.
4. S…
Contacts