Your session is about to expire
← Back to Search
Scleral Implant
Trial of the PresVIEW Implant for the Improvement of Near Vision in Patients With Presbyopia
N/A
Waitlist Available
Led By David Schanzlin, M.D.
Research Sponsored by Refocus Group, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.
Awards & highlights
No Placebo-Only Group
Summary
The primary objective of this study is to evaluate the safety and effectiveness of the PresVIEW™ Scleral Implant (PSI) for the improvement of near visual acuity in presbyopic patients.
Eligible Conditions
- Presbyopia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better or Improvement of 2 or More Lines
Secondary study objectives
Presence of Significant Safety Events (SAEs).
Other study objectives
Safety Parameter Point Estimate -- (Axial Length Increase >= 0.20) AND (Myopic Shift > 0.50D MRSE)
Safety Parameter Point Estimate -- (IOP Increase > 10 mmHg) or (IOP > 25 mmHg)
Safety Parameter Point Estimate -- Anterior Segment Ischemia
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Implantation-RandomizedExperimental Treatment1 Intervention
Subjects are participants in the randomized sub-study. Subjects were randomized to the Immediate Treatment group. PresView Scleral Implants surgical placed in the eye(s)Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria.
Group II: Implantation-Non RandomizedExperimental Treatment1 Intervention
Subjects are not participants in the randomized sub-study. PresView Scleral Implants surgical placed in the eye(s) after enrollment and meeting inclusion/exclusion criteria.
Group III: Deferred Implantation-RandomizedActive Control1 Intervention
Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria. Subjects were randomized to the Deferred Treatment group are observed for 6 months. Upon completion of the observation follow-up, subjects can opt to have PresView Scleral Implants surgically placed in the eye(s) and become part of the overall study experimental group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PresVIEW Scleral Implants
2003
N/A
~340
Find a Location
Who is running the clinical trial?
Refocus Group, Inc.Lead Sponsor
2 Previous Clinical Trials
652 Total Patients Enrolled
2 Trials studying Presbyopia
652 Patients Enrolled for Presbyopia
David Schanzlin, M.D.Principal InvestigatorChief Medical Officer