N/A
Completed N=287
Long Term Follow-up of the VisAbility™ Micro Insert System for Presbyopic Patients
Source: ClinicalTrials.gov NCT03811249 ↗Enrolled (actual)
287
Serious AEs
1.4%
Results posted
Nov 2023
Primary outcomePrimary: Primary Safety Measure - Partial or Complete Explantation — 2; 4 Eyes
Summary
The objective of this study is to obtain an additional 36 months of safety and effectiveness data from all subjects who were implanted with the VisAbility™ Micro Insert in the VIS-2014 clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Measure - Partial or Complete Explantation |
2; 4 | — |
| PRIMARY Primary Safety Measure - Anterior Segment Ischemia |
— | — |
| PRIMARY Primary Safety Measure - Segment Exposure. |
1 | — |
| PRIMARY Primary Safety Measure -Participants With Serious Ocular and Serious Non-Ocular Adverse Events |
0; 4; 1; 1; 1; 1 | — |
| SECONDARY Secondary Safety Measure - Best Corrected Distance Visual Acuity (BCDVA) in Eyes Examined at 36, 48 and 60 Month Visits |
363; 510; 330 | — |
| SECONDARY Secondary Safety Measure - Intraocular Pressure (IOP) |
0; 0; 0 | — |
| SECONDARY Secondary Safety Measure - Slit Lamp |
11; 0; 0; 0; 17; 7 | — |
| SECONDARY Secondary Safety Measure - Fundus Exam |
2; 1; 2; 2; 7; 3 | — |
| SECONDARY Secondary Safety Measure - Number of Participants With Adverse Events |
4; 3; 2; 3; 1; 5 | — |
| SECONDARY Secondary Effectiveness Measure - Distance Corrected Near Visual Acuity--Effectiveness Cohort |
2; 149; 212; 161 | — |
| SECONDARY Secondary Effectiveness Measure--Uncorrected Near Visual Acuity-Effectivness Cohort |
2; 135; 174; 128 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who were implanted with the VisAbility™ Micro Insert in Protocol VIS-2014
Exclusion Criteria
- N/A
Data sourced from ClinicalTrials.gov (NCT03811249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.